MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN BHR DEVICE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123144

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Toxicity (2333); Test Result (2695); No Code Available (3191)

Event Date 02/16/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery from the right hip was performed due to pseudotumor, constant pain in hip, elevated chromium and cobalt levels.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the femoral head was removed.The acetabular 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 has not become available.A review of the complaint history for the cup + head 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 + head.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable 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.The available medical documents were reviewed.The reported pain, elevated metal levels, pseudotumor, stained synovial fluid, synovitis, and osteolysis are consistent with an adverse reaction to metal debris; however, without the supporting lab results, imaging, and the analysis of the explanted components, the root cause of the reported clinical reactions cannot be confirmed, and it cannot be concluded that they 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 reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: UNKNOWN BHR DEVICE
• 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: 8290762
• MDR Text Key: 134560670
• Report Number: 3005975929-2019-00039
• 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
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 74123144
• Device Lot Number: 08MW20905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BHR DEVICE/ UNKNOWN LOT.
• Patient Outcome(s): Hospitalization; Required Intervention