MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 54 MM DUAL MOBILITY LINER; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Device Problem Use of Device Problem (1670)

Patient Problems Emotional Changes (1831); Discomfort (2330); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Asr litigation record received.Litigation alleges severe hip pain, discomfort, elevated metal ions, emotional distress, disability, disfigurement, permanent physical and economical injuries.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Reference report #mw5119376.

• Brand Name: 54 MM DUAL MOBILITY LINER
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.
• MDR Report Key: 17324532
• MDR Text Key: 319121915
• Report Number: MW5119377
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1