MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP JOINT REPLACEMENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Patient Problem Failure of Implant (1924)

Event Date 12/30/2023

Event Type  malfunction  

Event Description

It was reported that the patient was convert from a competitor cement cup to a pinnacle constrained.The loosening interface was cement to implant.Competitor cement was used.Unknown surgical delay.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: HIP JOINT REPLACEMENT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 18457424
• MDR Text Key: 332330651
• Report Number: MW5149866
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1