MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122158

Device Problems Material Fragmentation (1261); Unstable (1667); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 11/28/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery from the left hip was performed due to pain, instability, dislocations, elevated ion levels and metallosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr cup and bhr head were removed.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 and bhr head, 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 known 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.Although the cobalt and chromium levels were reported to be elevated, neither the levels nor the lab reports were provided.It is unknown to what extent the patient¿s medical history such as spine trauma and neuropathy could have been a contributing factor the reported pain.The intraoperative findings of stained tissue and fluid are consistent with findings associated with metallosis; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported elevated cobalt and chromium levels, pain, metallosis, dislocations, instability, and stained tissue and fluid 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.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr cup and head were removed.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 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.Non-conformances were identified for the castings inspection procedure paperwork for the bhr cup and bhr head.However, all supporting documents confirm that these were acceptable products 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.No further actions are required at this time.The available medical documents were reviewed.According to the provided revision report, the patient had pain.During the revision, stable components were noted and a synovium with layers of brownish tissue.Whether the brown synovium tissue corresponds the alleged metallosis cannot be determined based on the provided documents.Review of the provided implantation and revision report did not provided information that could explain the reasons for this revision in more detail.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• 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: 8355424
• MDR Text Key: 136716291
• Report Number: 3005975929-2019-00081
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 74122158
• Device Lot Number: 11JW34234
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123152 FEMORAL HEAD, LOT 11KW34516; UNKNOWN BHR DEVICE/ UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR