MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

Device Problems Fracture (1260); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348)

Event Date 08/30/2019

Event Type  Injury  

Event Description

It was reported a right hip revision surgery due to elevated chromium and cobalt levels, hip squeaking, chronic pain and a femoral neck fracture around the birmingham hip resurfacing arthroplasty, grey fluid and grey synovitis, with gray tissue staining on the capsule and bone loss.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the head and 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.All the 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 medical records were reviewed.Based on the information provided, the periprosthetic fracture at the right femoral neck is likely due to a work-related injury but if the femoral neck as weakened as a result of another pathology is unknown based on the information provided.The intraoperative findings of elevated cocr levels, synovitis, gray fluid and stained tissue are consistent with findings associated with metal debris.It cannot be determined whether the source of the reported intraoperative findings was a result of the wear associated with the fractured device or something else.Without the supporting radiographic images and/or the analysis of the explanted components, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and expected post-operative healing/pain cannot be determined.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.

Manufacturer Narrative

New information: g4, d4.

• Brand Name: ACETABULAR CUP HAP SIZE 48/54
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9474568
• MDR Text Key: 170933022
• Report Number: 3005975929-2019-00433
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2021
• Device Catalogue Number: 74122154
• Device Lot Number: 16CW14056
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123148 FEML HEAD 48MM 16GW00044
• Patient Outcome(s): Hospitalization; Required Intervention