MAUDE Adverse Event Report: STRYKER STRYKER ACCOLADE STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Defective Device (2588)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

From our instructions our client had difficulties with his hip and ultimately on the (b)(6) 2021 a part of the hip fractured and/or suffered a catastrophic trunnion failure.We are of the belief that the incident occurred as a result of a defective manufacture of the hip replacement.We are unable to say whether you or competitor uk limited is responsible for the defect.We now call upon you to admit responsibility and agree to compensate our client for the personal injury, loss and damage which he has sustained arising from 83 same.Original implant date (b)(6) 2009.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STRYKER ACCOLADE STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17526482
• MDR Text Key: 321113346
• Report Number: MW5133421
• 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: Other
• Type of Report: Initial
• Report Date: 01/20/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1