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 Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/14/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patients left hip due to elevated chromium and cobalt levels, muscle damage, cardiomyopathy, and chronic kidney disease from failed left hip resurfacing, consistent with metal¿on-metal wear and the resulting toxic effects of chromium and cobalt.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

It was reported that a left hip revision surgery was performed.The devices involved were all used in treatment.As of today 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.Medical the revision document does not note findings consistent with the complaint description of metal-on-metal wear or elevated metal ions.With the limited information provided the root cause of the reported cardiomyopathy, and chronic kidney disease and gluteus minimus tear cannot be confirmed and it cannot be concluded that the reported clinical relations were associated with a mal-performance of the implant.No follow-up information was provided beyond the revision.The patient impact beyond the 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.

Event Description

It was reported that, a left hip revision surgery was performed on (b)(6) 2020 due to elevated chromium and cobalt levels, muscle damage, cardiomyopathy, and chronic kidney disease from failed left hip resurfacing, consistent with metal¿on-metal wear and the resulting toxic effects of chromium and cobalt.During the revision surgery, the resurfacing metallic femoral head was explanted and replaced with a tha system.The primary left hip surgery was performed on (b)(6) 2010.

Manufacturer Narrative

H10.Additional information in a1, a2, a3, a4, b6, b7, d4 (expiration date) and h4.H11.Corrected information in b5 and h6 (medical device problem code).

Manufacturer Narrative

It was reported that, a left hip revision surgery was performed due to elevated chromium and cobalt levels, muscle damage, cardiomyopathy, and chronic kidney disease from failed left hip resurfacing, consistent with metal¿on-metal wear and the resulting toxic effects of chromium and cobalt.During the revision surgery, the resurfacing metallic femoral head was explanted and replaced with a total hip arthroplasty system.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the bhr cup and head.This will continue to be monitored via routine trending, however it should be noted that this device is no longer sold.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.The revision document does not note findings consistent with the complaint description of metal-on-metal wear.Patient had a history of tia and cad s/p mi in 2009, prior to left bhr implantation.It is also noted patients¿ chronic kidney disease was diagnosed as fsgs.With the information provided the clinical root cause of the reported cardiomyopathy, chronic kidney disease and gluteus minimus tear cannot be definitively confirmed: however, the patient¿s comorbidities cannot be ruled out as possible contributing factors to his reported pain and clinical status.Having decreased kidney function can impact the clearance of the reported metal ions as well and cannot be ruled out as a contributing factor as there are no symptoms consistent with metal-on-metal wear.It cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• 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 warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone ; aurora house; spa park; leamington spa, warwickshire ; UK ; 4414826737
• MDR Report Key: 10261813
• MDR Text Key: 198496215
• Report Number: 3005975929-2020-00241
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2013
• Device Catalogue Number: 74120160
• Device Lot Number: 095438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 77 KG