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

Catalog Number UNKNOWN

Device Problems Malposition of Device (2616); Biocompatibility (2886); Migration (4003)

Patient Problem Metal Related Pathology (4530)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case- (b)(4).

Event Description

*us legal* bilateral patient.It was reported that, after a right bhr on (b)(6) 2010 due to severe arthritis.Plaintiff experiences elevated levels of cobalt and chromium ions.Advanced imaging demonstrated a collection of fluid around the right hip.Due to failed implants with metallosis, pseudotumor and malposition of components, plaintiff underwent right revision surgery on (b)(6) 2021 where significant retro acetabular osteolysis and signs of bone holes were found.The status of the patient is unknown.

Event Description

It was reported that, after a right bhr on (b)(6), 2010 due to severe arthritis.Plaintiff experiences elevated levels of cobalt and chromium ions.Advanced imaging demonstrated a collection of fluid around the right hip.Due to failed implants with metallosis, pseudotumor and malposition of components, plaintiff underwent right revision surgery on (b)(6), 2021 where significant retro acetabular osteolysis and signs of bone holes were found.The status of the patient is unknown.

Manufacturer Narrative

B4, h3, h6: it was reported that revision surgery was performed on the patient¿s right hip.As of today, the devices used in treatment have been requested but have not become available.Without definitive lot numbers, a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.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 information was reviewed.The reported pain, elevated metal ions, pseudotumor and intraoperative finding of the retroverted acetabular component can be seen as a result of metallosis, but changes in position could also accelerate wear and lead to metal debris and result in metallosis.With the information provided, the root cause of the reported pain, elevated metal ions, and metallosis cannot be confirmed.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 reported complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight and trauma to the joint replacement.If the products or additional information become available in the future, this case will be reopened.Based on the results of this investigation, the need for corrective or preventative action is not indicated.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14429598
• MDR Text Key: 291929459
• Report Number: 3005975929-2022-00253
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female