MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123152

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 12/19/2018

Event Type  Injury  

Event Description

It was reported that, after a bhr construct had been implanted on a left hip arthroplasty, the patient experienced pain because of a loose femoral head.A revision surgery was performed to treat this event.The patient was not harmed.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup and head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr head and bhr cup, was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.The bhr cup involved met manufacturing specifications at the time of production.Non-conformance was identified for the castings inspection procedure paperwork for the bhr head.However, all supporting documents confirm that this was an acceptable product when released.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 and no further actions are required at this time.The available medical documents were reviewed.Although loosening of the femoral head and osteolysis were noted intraoperatively; without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, loosening of the femoral head and osteolysis cannot be confirmed and it cannot be concluded that the reported clinical reactions 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.No post revision follow-up information was provided.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: FEMORAL HEAD 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 10227459
• MDR Text Key: 197403013
• Report Number: 3005975929-2020-00224
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2011
• Device Catalogue Number: 74123152
• Device Lot Number: 8017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP; UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP
• Patient Outcome(s): Hospitalization; Required Intervention