MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 60MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120160

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Pain (1994); Rash (2033); Injury (2348)

Event Date 10/29/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery of the left hip was performed due to: severe pain, failed left hip resurfacing, elevated levels of cobalt and chromium, skin rash, loss of mobility, loss of strength, osteolysis, bone and tissue loss, cysts and pseudotumors, brain fog and metallosis.Bilateral patient.There's confirmation that non medical intervention has been performed for right hip.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr head and cup 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 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 available medical documents were reviewed.The intraoperative findings of the reported elevated metal ion levels and altr may be consistent with findings associated with metal debris; however, the root cause of the reported symptoms cannot be concluded.Further, it cannot be concluded that the reported 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.

• Brand Name: ACETLR CUP HAP 60MM 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 CV313 HL; UK CV313HL
• MDR Report Key: 8181508
• MDR Text Key: 130970717
• Report Number: 3005975929-2018-00543
• 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
• Report Date: 04/16/2020

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: 03/31/2013
• Device Catalogue Number: 74120160
• Device Lot Number: 084988
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 12/09/2018
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121154 RESURFACING FEMORAL HEAD 54MM L#086790.; UNKNOWN BHR DEVICE/UNKNOWN LOT.
• Patient Outcome(s): Hospitalization; Required Intervention