MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BICON-PLUS TITANIUM SHELL 3-49 NON-CEM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 75004169

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 11/22/2012

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed in the right hip, for the removal of exostosis at trochanter major and bursectomy, as well as removal of periarticular calcifications.No implants were explanted.

Manufacturer Narrative

H3, h6: it was reported that a revision surgery was performed in the right hip, for the removal of exostosis at trochanter major and bursectomy, as well as removal of periparticular calcifications.No implants were explanted.The device intended for use in treatment was not returned for investigation nor was a batch number communicated.An appropriate investigation could therefore not be conducted and the reported failure mode could not independently be confirmed.A review of the complaint history revealed no complaint reported for a similar issue for the device in scope.A medical investigation was conducted based on available medical records.The reported pain and subsequent bursectomy and surgical removal of the exostosis, periparticular calcifications are not associated with a malperformance of the implant.As well, the root cause for the heterotopic ossification cannot be concluded but some patients can be genetically predisposed, it is a known complication of joint surgeries and is related to the procedure and not the device.The ifu (lit.No.12.23 ed 05/16) lists several adverse issues as a known possible side effects resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the information provided, the root cause for the reported issue is not related to the device.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: BICON-PLUS TITANIUM SHELL 3-49 NON-CEM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11409097
• MDR Text Key: 234625506
• Report Number: 9613369-2021-00097
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75004169
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR