MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121150

Device Problem Osseointegration Problem (3003)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

Us legal.It was reported that, after a bhr resurfacing construct had been implanted on the plaintiff¿s left hip on (b)(6) 2010, the plaintiff experienced disabling left hip, groin pain caused by left hip arthroplasty failure and femoral component failed into varus.A revision surgery was performed on (b)(6) 2016 to treat this adverse event.Intraoperatively, it was noticed that the femoral component was loose.Patient was brought to recovery room in stable condition.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in said revision, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the femoral head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified and this failure will continue to be monitored.On account of the fact devices reportedly involved in this incident were not returned for evaluation, the relevant production records were reviewed.All released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.The reported pain and varus position of the femoral component are consistent with the loose femoral component noted intraoperatively.However, with the information provided the clinical root cause of the loose femoral component cannot be confirmed and it cannot be concluded that the reported events were associated with a malperformance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the applicable devices or further information we cannot advance the investigation or confirm the details supplied in this complaint.Furthermore, our investigation remains inconclusive and a definitive root cause cannot be determined.Due to the insufficient information provided, we are unable to determine specific factors known to contribute to the alleged fault.If the devices or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective action is not indicated.H6: update codes.

• Brand Name: RESURFACING FEMORAL HEAD 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 12477679
• MDR Text Key: 271651695
• Report Number: 3005975929-2021-00407
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

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 Expiration Date: 02/28/2014
• Device Model Number: 74121150
• Device Catalogue Number: 74121150
• Device Lot Number: 98652
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 54 YR