MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Osteolysis (2377)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

*us legal* it was reported that, after a left bhr was performed on (b)(6) 2009 due to degenerative arthritis, the patient experienced pain and a loose femoral component resulting from avascular necrosis of femoral head.This adverse event was treated with a revision surgery on (b)(6) 2020.Patient's current health status is unknown.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to the patient experiencing pain and a loose femoral component resulting from avascular necrosis of femoral head.During the surgery the femoral head was removed.As of today, the implanted device, which was used in treatment has not been returned for evaluation.A review of the historical complaints data for the femoral head was performed, using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.Using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Another complaint was identified to involve this batch.Other similar complaints were identified for the part number and the reported/related failure mode.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.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 mode and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.The available medical documents were reviewed.According to the revision operative report, the patient had a progressive degree of left hip symptoms and x-ray suggestive of subsidence of the femoral component of the bhr construct.The surgeon noted there was no evidence of metallosis and the femoral component was grossly loose and easily removed.It was also noted that there was osteonecrotic change of the femoral head, which, according to the surgeon, explained the patient¿s pain and subsidence of the femoral component.There was also an area along the inferior aspect of the component that somewhat deficient to bone.Based on the information provided, the pain, loosening and subsidence of the femoral head, and osteolysis is most likely attributed to the osteonecrotic change of the femoral head.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision cannot be determined.Based on the available information provided we can confirm the reported complaint.A probable root cause of the reported failure is the osteonecrotic change of the femoral head.If the products or additional information become available in the future, this case will be reopened.Based on this investigation the need for corrective and preventative action is not indicated.

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• 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: 14075544
• MDR Text Key: 289012632
• Report Number: 3005975929-2022-00148
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502780
• UDI-Public: 3596010502780
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2013
• Device Catalogue Number: 74121146
• Device Lot Number: 082774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• 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): Other