MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121150

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Pain (1994); Toxicity (2333); Injury (2348); Test Result (2695); Test Result (2695)

Event Date 01/10/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery of the left hip was performed due to pain.An x-ray showed migration of the femoral component consistent with femoral loosening.In addition, cobalt and chromium levels were high.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The cup remained implanted.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 full documentation review could not be performed as device batch details have not currently been made available.A review of the complaint history for the head and cup was performed using part numbers in search of similar recurring reports, involving femoral loosening, for the products during their lifetimes.Similar complaints have been identified and this will continue to be monitored.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.Although it was reported that the cobalt and chromium levels were elevated, only the levels from 1 year prior were provided which did show some elevation above reference values.Without the implantation and pre-revision x-rays to determine initial implant anatomical placement and any micro-motion over time (for loosening), this cannot be ruled out as a contributory factor to the reported elevated cobalt and chromium levels which is also the statement of the surgeon that this did not represent metallosis.Additionally, 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, and loosening of the femoral component 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 left hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.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 head was performed using part numbers in search of similar recurring reports for the products during their lifetimes.A full complaint history review could not be performed due to no batch numbers provided.Similar complaints have been identified and this failure will continue to be monitored.The production records or specific ifu could not be reviewed for the devices reportedly involved in this incident as batch numbers were not provided.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.Although it was reported that the cobalt and chromium levels were elevated, neither the levels nor the lab reports were provided.Without the implantation and pre-revision x-rays to determine initial implant anatomical placement and any micro-motion over time, for loosening, this cannot be ruled out as a contributory factor to the reported elevated cobalt and chromium levels.It is also the statement of the surgeon that this did not represent metallosis.Additionally, 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, and loosening of the femoral component 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: RESURFACING FEMORAL HEAD 50MM
• 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: 8065986
• MDR Text Key: 127049498
• Report Number: 3005975929-2018-00446
• 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: 06/18/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74121150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Required Intervention