MAUDE Adverse Event Report: ZIMMER GMBH ZIMMER HIP JOINT REPLACEMENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Device Problems Unintended Movement (3026); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

It was reported that the surgeon was not satisfied with the stability of the construct after implanting a new head with zimmer dual mobility.He removed the head and cup and put in a larger zimmer cup and switched to our 36 head with a longer neck length.Doi: unknown, dor: (b)(6) 2023 affected side: right hip.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ZIMMER HIP JOINT REPLACEMENT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER GMBH
• MDR Report Key: 18374591
• MDR Text Key: 331301483
• Report Number: MW5149438
• Device Sequence Number: 1
• Product Code: LZO
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1