MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER FEMORAL STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/02/2022

Event Type  Injury  

Event Description

This fda report is about a patient who underwent a right total hip arthroplasty on (b)(6) 2012.He did well for many years, but in mid-(b)(6) , developed worsening right hip and thigh pain, seeking emergency services in (b)(6) 2022 when he became unable to walk or move without significant pain.Following the (b)(6) 2022 ed work-up, the surgeon recommended revision surgery for this patient, noting "the diagnosis was somewhat unclear, but at the very least he had metallosis and adverse local tissue reaction and i believe he was also suffering from varus migration of his stem with a stress reaction of the femur that renders him unable to walk." reference reports: mw5117294, mw5117295, mw5117297.

• Brand Name: ZIMMER FEMORAL STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 16886715
• MDR Text Key: 314859629
• Report Number: MW5117296
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/02/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRILOGY ACETABULAR SYSTEM.; VERSYS HIP SYSTEM.; ZIMMER 12/14 COCR FEMORAL HEAD 36MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White