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

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530)

Event Date 05/23/2019

Event Type  Injury  

Event Description

Us legal mdl - it was reported that a revision surgery was performed on the patient's right hip due to pain, limited mobility, and elevated metal ion levels.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.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 and lot numbers a complaint history / dhr / device labelling review cannot be performed for the devices involved.Should the lot / batch / serial number become available at a later date then a complaint history / dhr / device labelling task will be re-opened and completed.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 ions and operative findings of milky joint fluid and mild changes of the synovium may be consistent with findings associated with metal debris; however, the root cause of the reported pain, elevated cobalt and chromium levels, milky joint fluid and mild changes of the synovium cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.In addition, the slightly posterior and slightly retroverted acetabular component as well as the reported trunnionosis of the contralateral side (depuy) cannot be ruled out as contributing factors to the reported clinical reactions and reported lab values.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: 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 10173401
• MDR Text Key: 195725643
• Report Number: 3005975929-2020-00203
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention