MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG HIP REPLACEMENT DEVICE; PROSTHESIS, HIP, HEMI - FEMORAL, METAL / POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 71336500ETC

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Toxicity (2333); Cognitive Changes (2551)

Event Date 03/31/2011

Event Type  Injury  

Event Description

Left hip replacement with smith & nephew device causing metal-on-metal toxic side effects.Chromium and cobalt elevated levels which indicated replacement device surgery as soon as possible.Experiencing cognitive decline and pain.Since the beginning, a clicking noise has always been present in the left hip.

• Brand Name: HIP REPLACEMENT DEVICE
• Type of Device: PROSTHESIS, HIP, HEMI - FEMORAL, METAL / POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG
• MDR Report Key: 8186264
• MDR Text Key: 131328084
• Report Number: MW5082360
• Device Sequence Number: 3
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/18/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 71336500ETC
• Device Lot Number: 10JM13823ETC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 67 YR
• Patient Weight: 58