MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348)

Event Date 02/18/2020

Event Type  Injury  

Event Description

It was reported that, after a bhr construct had been implanted in a right hip arthroplasty, the patient experienced unexplained pain, difficulty walking, and elevated cobalt and chromium levels.Such toxic effects of heavy metal-on-metal wear were addressed by performing a medically-indicated revision surgery.The patient was not harmed.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right 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 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 for the bhr head.Similar complaints have been identified for the bhr 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 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.The clinical information provided, of the elevated metal ion levels and the necrotic tissue may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The hematoma post revision was likely due to his factor 5 leiden mutation.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 52MM 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 warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10114101
• MDR Text Key: 193613893
• Report Number: 3005975929-2020-00172
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2018
• Device Catalogue Number: 74120152
• Device Lot Number: 13BW09400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention