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 Problem Compatibility Problem (2960)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/13/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patients left hip due to severity of the pain and the impending catastrophic implant failure, elevated levels of ions in the left hip with mild bone loss.The patient outcome is unknown.

Manufacturer Narrative

It was reported that a revision surgery was performed on the patients left hip.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 cup, hemi head, sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the hemi head and sleeve.However, as the device is no longer sold, no action is to be taken.No other similar complaints were identified for the cup and stem.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 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 pain, may be consistent with a reaction to metal debris or trunnionosis.However, the source and the root cause cannot be confirmed with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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 was performed on the patients left hip.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 cup, hemi head, sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the hemi head and sleeve.However, as the device is no longer sold, no action is to be taken.No other similar complaints were identified for the cup and stem.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 and no further actions are required at this time.The available medical documents were reviewed.The reported pain, elevated cobalt, intraoperative findings of adverse local tissue response (altr) and trunnionosis may be consistent with findings associated with metal debris.However, the root cause of the reported pain, elevated cobalt, altr and trunnionosis 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 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.

• 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: 10405953
• MDR Text Key: 202854174
• Report Number: 3005975929-2020-00294
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120156
• Device Lot Number: 079666
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention