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 75003740

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

Patient Problems Failure of Implant (1924); Pain (1994); Hernia (2240)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that after the primary right hip surgery performed in 2004, the patient started experiencing spine problems and in 2010 had to have a discus hernia surgery, at the same time decompression in spinal tightness.

Manufacturer Narrative

H3, h6: it was reported that after the primary right hip surgery performed in 2004, the patient started experiencing spine problems and in 2010 had to have a discus hernia surgery, at the same time decompression in spinal tightness.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 spine problems and subsequent discus hernia surgery and decompression are related to degenerative changes in the lumbar spine and disc herniation and is not associated with a mal-performance of the implant.The patient impact beyond the decompression with stabilization cannot be determined.Instructions for use (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: 11409094
• MDR Text Key: 234624798
• Report Number: 9613369-2021-00096
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75003740
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR