MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problems Degraded (1153); Naturally Worn (2988); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Swelling (2091); Toxicity (2333); Injury (2348); Ambulation Difficulties (2544); Test Result (2695)

Event Date 12/06/2019

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to unexplained pain, difficulty walking, elevated chromium and cobalt levels, pseudotumor, alval, significant synovitis with fibrohistiocytic reaction and regions of fibrinoid degeneration from a failed right hip resurfacing arthroplasty, consistent with metal-on-metal wear.

Manufacturer Narrative

It was reported that left 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 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 cup & head.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable 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 medical records were reviewed.Based on the information provided, the reported elevated metal ion levels, pseudotumor/alval, and synovitis may be consistent with findings associated with metal debris though it was reported no bony degeneration or avascular necrosis or metallosis or discoloration.Without supporting radiographic images, and/or the analysis of the explanted components, 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: ACETLR CUP HAP 56MM W/ IMPTR
• 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: 9552265
• MDR Text Key: 173752364
• Report Number: 3005975929-2020-00002
• 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,Followup
• Report Date: 10/22/2020

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: 10/31/2015
• Device Catalogue Number: 74120156
• Device Lot Number: 10KW30241
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 07/06/2020; 08/18/2020
• Supplement Dates FDA Received: 07/08/2020; 10/22/2020
• Patient Sequence Number: 1
• Treatment: 74121150 RESURF FEM HEAD 50MM 10MW31052; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN