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

Catalog Number 74120160

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Scar Tissue (2060); Synovitis (2094); Metal Related Pathology (4530)

Event Date 10/16/2019

Event Type  Injury  

Event Description

It was reported that, after a bhr tha construct had been implanted on the right hip, the patient experienced persistent pain, synovitis and metallosis.A revision surgery was performed to treat the adverse event.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that a revision surgery was performed on the right hip.The devices involved were all used in treatment.As of today additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi head, stem and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for sleeve and this failure will continue to be monitored.No other similar complaints were identified for the head, cup and stem.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.The revision document does not note findings consistent with the complaint description of metallosis.The reported pain may be associated with the scar tissue; however, the root cause for the scar tissue cannot be concluded but some patients can be genetically predisposed as it is a known complication of joint surgeries and is related to the procedure and not the device.With the information provided the root cause of the excessive amount of fluid and mild synovitis cannot be confirmed and it cannot be concluded that the reported 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 BIRMINGHAM HIP RESURFACING (BHR) CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 10438914
• MDR Text Key: 203978610
• Report Number: 3005975929-2020-00302
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74120160
• Device Lot Number: 086149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention