MAUDE Adverse Event Report: SMITH & NEPHEW BIRMINGHAM HIP RESURFACING SYSTEM

Lot Number 09DW22936

Device Problems Nonstandard Device (1420); Metal Shedding Debris (1804)

Patient Problem Death (1802)

Event Type  Death  

Event Description

My husband had the smith and nephew birmingham hip resurfacing system implanted in 2010.We were never in formed of all the adverse health effects from metal on metal hip implants, which can cause systemic disease.Cobalt and chromium metal ions injured my husband's heart which led to his death.We were not informed of recalls of metal on metal hip implants; the need for monitoring of cobalt and chromium metal ions; and ultimately the need for revision.

• Brand Name: BIRMINGHAM HIP RESURFACING SYSTEM
• Type of Device: HIP RESURFACING SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW
• MDR Report Key: 7101272
• MDR Text Key: 94374821
• Report Number: MW5073862
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: H729713411581L
• UDI-Public: +H729713411581L
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Lot Number: 09DW22936
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Disability
• Patient Age: 57 YR
• Patient Weight: 91