MAUDE Adverse Event Report: ZIMMER, INC. TRILOGY ACETABULAR SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

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 11/5/2012.He did well for many years, but in (b)(6) 2022, 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, mw5117296.

• Brand Name: TRILOGY ACETABULAR SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 16886729
• MDR Text Key: 314855041
• Report Number: MW5117297
• 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: VERSYS HIP SYSTEM.; ZIMMER 12/14 COCR FEMORAL HEAD 36MM.; ZIMMER FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White