MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74123148
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a thr surgery was performed on (b)(6) 2016, the patient experienced migration and collapse of a bhr resurfacing femoral head 48mm due to bad bone quality.This adverse event was treated by a revision surgery on (b)(6) 2022, in which a the femoral head was replaced with a femoral stem and a dual mobility insert.The patient's current health status is unknown.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to migration and collapse of a bhr femoral head related to unhealthy bone tissue.The patient's current health status is unknown.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the device was performed using the batch number, part number and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for he femoral head, this will continue to be monitored.In the absence of the actual device, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the product and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.The reported ¿bad bone quality¿ cannot be ruled out as a contributing factor to the reported migration and collapse of the femoral head and subsequent revision 6 years later.The patient impact beyond the revision and expected convalescence period cannot be determined with the limited information provided.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Besides the unhealthy bone tissue, other specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
Event or Problem Description
It was reported that, after a thr surgery was performed on (b)(6) 2016, the patient experienced migration and collapse of a bhr resurfacing femoral head 48mm due to unhealthy bone tissue.This adverse event was treated by a revision surgery on (b)(6) 2022, in which a the femoral head was replaced with a femoral stem and a dual mobility insert.The patient's current health status is unknown.

• Brand Name: BHR RESURFACING FEMORAL HEAD 48MM
• Common Device Name: 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: 15610824
• Report Number: 3005975929-2022-00476
• Device Sequence Number: 16825553
• Product Code: NXT
• UDI-Device Identifier: 03596010552426
• UDI-Public: 03596010552426
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 74123148
• Device Catalogue Number: 74123148
• Device Lot Number: 16AW03994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 09/20/2022; 11/03/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 10/24/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 64 KG