# P040033: Birmingham Hip Resurfacing (BHR) System

- Pathway: PMA
- Applicant: Smith & Nephew, Inc.
- Decided: May 9, 2006 after 659 days
- Product code: NXT (Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing)
- Device class: 3
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 14, 2021 · Class II · Z-2242-2021: The nail head may become detached during surgery.
- May 11, 2018 · Class II · Z-2268-2018: The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information B
- May 11, 2018 · Class II · Z-2267-2018: The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information B
- Jun 3, 2015 · Class II · Z-2745-2015: The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
- Jun 3, 2015 · Class II · Z-2747-2015: The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
- Jun 3, 2015 · Class II · Z-2746-2015: The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
- Jul 12, 2007 · Not classified · Z-0016-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0020-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0027-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0029-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0031-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0017-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0018-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0019-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0021-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0022-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0024-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0028-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0033-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0023-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0025-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0026-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0030-2008: The carton label may not reflect the correct size of the acetabular cup.
- Jul 12, 2007 · Not classified · Z-0032-2008: The carton label may not reflect the correct size of the acetabular cup.
- Mar 13, 2007 · Not classified · Z-0866-2007: The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
- Mar 13, 2007 · Not classified · Z-0863-2007: The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
- Mar 13, 2007 · Not classified · Z-0865-2007: The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
- Mar 13, 2007 · Not classified · Z-0862-2007: The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
- Mar 13, 2007 · Not classified · Z-0864-2007: The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.

Source page: https://510kreport.com/device/P040033
Methodology: https://510kreport.com/methodology