MAUDE Adverse Event Report: SMITH & NEPHEW, INC. METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED

Patient Problem Failure of Implant (1924)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that patient had poly wear in srom/richards cup construct.Cup was explanted.Emsys mh cup was implanted.Srom head was changed from 28 +6 to 36 +6.Oit was unknown, if there was a surgical delay.Affected side- left hip.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED
• Type of Device: METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 18874252
• MDR Text Key: 337462821
• Report Number: MW5152528
• Device Sequence Number: 1
• Product Code: MRA
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2024
• Patient Sequence Number: 1