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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 01/13/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to left hip pain, left hip limited motion, metallosis elevated cobalt and chromium metal ions.

Manufacturer Narrative

As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.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 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 devices reportedly involved in this incident.The bhr cup involved met manufacturing specifications at the time of production.Non-conformance was identified for the castings inspection procedure paperwork for the bhr head.However, all supporting documents confirm that this was an acceptable product when released.Additionally, it was also confirmed that all devices were sterilised.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.It cannot be determined to what extent the patient¿s comorbidities had on his clinical status.Although it was reported the patient had elevated cobalt and chromium serum levels, neither the levels nor the lab reports were provided for review.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, infection, and elevated metal ion levels 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, CV313 HL; UK CV313HL
• MDR Report Key: 8020907
• MDR Text Key: 125532619
• Report Number: 3005975929-2018-00406
• 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: 04/14/2020

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
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 10/08/2018; 10/08/2018
• Supplement Dates FDA Received: 01/28/2019; 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BHR DEVICE.
• Patient Outcome(s): Hospitalization; Required Intervention