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 Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Debris, Bone Shedding (1803); Pain (1994); Weakness (2145); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 10/15/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery of left hip was performed due to pain, failed left hip resurfacing, loss of mobility, loss of strength, tissue and bone loss, elevated levels of cobalt and chromium, and metallosis.

Manufacturer Narrative

It was reported that a revision surgery of the left hip was performed.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 / 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 cup.A similar complaint was found for the head and this will continue to be monitored.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.It was noted that the implant operative report refers to a femoral stem and poly liner, however only classic resurfacing components are listed.The available medical documents were reviewed.The reported clinical symptoms may be consistent with findings associated with metal debris; however, without the revision operative report, supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported symptoms noted in the legal claim cannot be confirmed, and it cannot be concluded that the reported reactions/events are associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected post-op healing 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

It was reported that a revision surgery of the left hip was performed.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 / 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 cup.A similar complaint was found for the head and this will continue to be monitored.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.It was noted that the implant operative report refers to a femoral stem and poly liner, however only classic resurfacing components are listed.The available medical documents were reviewed.The reported clinical symptoms may be consistent with findings associated with metal debris; however, without the revision operative report, supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported symptoms noted in the legal claim cannot be confirmed, and it cannot be concluded that the reported reactions/events are associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected post-op healing 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 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 CV313 HL; UK CV313HL
• MDR Report Key: 8200924
• MDR Text Key: 131544981
• Report Number: 3005975929-2018-00561
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2011
• Device Catalogue Number: 74120152
• Device Lot Number: 69934
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121146 HEAD, LOT 74632; UNKNOWN DEVICE/UNKNOWN LOT; UNKNOWN DEVICE/UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR