MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Degraded (1153); Material Discolored (1170); Naturally Worn (2988)

Patient Problems Pain (1994); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 08/28/2019

Event Type  Injury  

Event Description

It was reported that a left hip revision was performed due to unexplained chronic pain, difficulty walking, and elevated chromium and cobalt levels consistent with metal-on-metal wear, extensive discoloration of the soft tissue consistent with metal debris.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.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 cup & head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the head.Similar complaints have been identified for the cup.However, as bhr systems of this size are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known 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 and no further actions are required at this time.The available medical documents were reviewed.The root cause of the patient¿s reported chronic left hip pain and squeaking cannot be concluded.The intraoperative report of elevated cocr levels and discolored soft tissue may be consistent with findings associated with metal debris, although the acetabular component was noted to be well fixed without signs of failure.Based on the provided information the source of the reported findings cannot be confirmed, and 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: RESURFACING FEMORAL HEAD 46MM
• 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: 9752070
• MDR Text Key: 180802979
• Report Number: 3005975929-2020-00073
• 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: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2012
• Device Catalogue Number: 74121146
• Device Lot Number: 079620
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120154 ACE CUP HAP 54MM W/ IM 077305
• Patient Outcome(s): Hospitalization; Required Intervention