MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 58MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120158

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

Patient Problems Ossification (1428); Cyst(s) (1800); Pain (1994); Injury (2348); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 01/07/2020

Event Type  Injury  

Event Description

It was reported that, after a left-side bhr construct had been implanted in a knee arthroplasty, the patient experienced unexplained pain, difficulty walking, pseudotumor and elevated chromium and cobalt levels.A medically-indicated revision surgery was performed to treat the adverse event.The patient outcome is unknown.

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 bhr cup & head 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 head.Similar complaints were identified for the cup and this will continue to be monitored.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 documents were reviewed.The revision operative report noted ¿pseudotumor, dark staining, dysvascular/avascular tissue, heterotopic bone and scar tissue.¿ it is also noted gram stains were all negative and tissue was negative for evidence of acute inflammation.Conclusion: the pseudotumor, dark staining, dysvascular/avascular tissue may be consistent with findings associated with metallosis; however, the root cause of the pseudotumor, dark staining, dysvascular/avascular tissue and metallosis cannot be confirmed and it cannot be concluded that the reported reactions were associated with a mal-performance of the implant.The root cause for the ¿heterotopic bone and scar tissue¿ cannot be concluded but some patients can be genetically predisposed they are known complications of joint surgeries and is related to the procedure and not the device.The patient impact beyond the pain, revision, and expected transient post-op convalescence period 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

Event description corrected.

Event Description

It was reported that, after a left-side bhr surgery, the patient experienced unexplained pain, difficulty walking, pseudotumor and elevated chromium and cobalt levels.A medically indicated revision surgery was performed to treat the adverse event.The patient outcome is unknown.

• Brand Name: ACETLR CUP HAP 58MM 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: 10114130
• MDR Text Key: 193617912
• Report Number: 3005975929-2020-00174
• 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: 12/11/2020

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 Catalogue Number: 74120158
• Device Lot Number: 077916
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention