MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH & NEPHEW R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, 52 MM ; PROSTHESIS HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335552

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 10/10/2018

Event Type  Injury  

Event Description

I had a metal-on-metal total hip arthroplasty made by smith & nephew implanted in me in 2009 and it needed to be revised due to excessive metal wear.

• Brand Name: SMITH & NEPHEW R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, 52 MM
• Type of Device: PROSTHESIS HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 8727214
• MDR Text Key: 149145548
• Report Number: MW5087551
• Device Sequence Number: 1
• Product Code: MBL
• 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
• Type of Report: Initial
• Report Date: 06/03/2019
• 4 Devices were Involved in the Event: 1 2 3 4

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: 71335552
• Device Lot Number: 09EM21016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 98