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

Model Number 74121146

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Failure of Implant (1924); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 01/05/2010

Event Type  Injury  

Manufacturer Narrative

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

Event Description

*us legal * it was reported that, after a left birmingham resurfacing on (b)(6) 2006 due to degenerative joint disease, plaintiff has experience loosening of femoral component.A revision surgery was performed on (b)(6) 2010 where it was converted to bhr tha.Patient outcome is unknown.

Event Description

It was reported that, after a left birmingham resurfacing on (b)(6) 2006 due to degenerative joint disease, plaintiff has experience loosening of femoral component and pain that was treated with marcaine and lidocaine injections.As the problem was not solved, a revision surgery was performed on (b)(6) 2010 where it was converted to bhr tha.Patient outcome is unknown.

Manufacturer Narrative

H10.Additional information in b5 and b7.Internal reference number: (b)(4).

Manufacturer Narrative

H3, h6: it was reported that a revision surgery was performed on the patient's left hip.As of today, the implanted devices all of which were used in the treatment, and additional information has been requested for this complaint but has 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 and device labelling / ifu review could not be performed.All of the devices would have met manufacturing specifications at the time of production.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 and no further actions are required at this time.The provided operative reports have been reviewed.However, they do not aid in determining a root cause for the reported loosening of the femoral component.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.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 cannot be provided due to the insufficient information.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.

Manufacturer Narrative

Section d4 were updated.

Manufacturer Narrative

H10: additional information in h6 (codes e, f and a were updated).H3, h6.It was reported that a revision surgery was performed on the patient's left hip.As of today the devices used in treatment have been requested but have not become available.A review of the complaint history was performed using the part number the head and the failure mode.Other similar complaints have been identified for the head.However, as the device is no longer sold, no action is to be taken.As no device batch numbers were provided for investigation, a manufacturing record review, device labelling and ifu review could not be performed.A risk management review was not performed as the device has been phased out from the market and as a result there is no live risk management file to review.A review of prior escalation actions was completed using the available information.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; no further escalation actions required.The available medical information was reviewed.The physician¿s note along with the revision operative report confirmed the loosening of the femoral component.However, the root cause of the aseptic loosening, pain, and pathological findings cannot be confirmed.It cannot be concluded that the reported clinical symptoms are associated with a malperformance of the implant.The impact to the patient beyond that which has already been reported cannot be concluded.Based on the information and reports provided, we are able to confirm the reported complaint.However, a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault may include excessive physical activity levels or 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: 12952269
• MDR Text Key: 281850759
• Report Number: 3005975929-2021-00557
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502780
• UDI-Public: 03596010502780
• 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,Followup,Followup,Followup
• Report Date: 05/26/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 74121146
• Device Catalogue Number: 74121146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 01/13/2022; 01/17/2022; 05/05/2022; 05/25/2022
• Supplement Dates FDA Received: 01/14/2022; 01/28/2022; 05/11/2022; 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male