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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 10/10/2018

Event Type  Injury  

Event Description

It was reported a revision surgery of the right hip was performed due to severe pain, failed right hip resurfacing, osteolytic lesion, bone and tissue death, pseudo-tumors, elevated levels of cobalt and chromium, loss of mobility, and metallosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr head and cup 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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history for the bhr cup and head was performed using part numbers in search of similar recurring reports involving metallosis and osteolytic lesion for the products during their lifetimes.No other similar complaints were identified.As no device lot details were provided, a documentation review nor ifu review could be performed.If more information is received, this investigation will be reopened.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 the cobalt and chromium levels were reported to be elevated, neither the levels nor the lab reports were provided.The acetabular component was noted to be significantly anteverted; without the implantation and pre-revision x-rays to determine initial implant anatomical placement and any micro-motion over time, this cannot be ruled out as a contributory factor to the reported issues.The intraoperative findings of an osteolytic lesion and stained tissue and synovium 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, loss of mobility, osteolytic lesion, bone and tissue death, pseudotumors, and stained tissue and synovium 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: 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: 8247688
• MDR Text Key: 133051251
• Report Number: 3005975929-2019-00018
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BHR DEVICE/ UNKNOWN LOT; UNKNOWN BHR DEVICE/ UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention