MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Arthralgia (2355); Unequal Limb Length (4534)

Event Date 12/17/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Us legal.It was reported that, after a bhr resurfacing joint prosthesis had been implanted on the plaintiff¿s right hip on (b)(6) 2008, the plaintiff experienced pain, leg length discrepancy and impingement at the head neck junction.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.During this procedure, the bhr femoral head was resected and replaced with a total hip replacement prosthesis, leaving the acetabular cup in place and implanting a dual mobility liner.Intraoperatively, avascular necrosis was noted around the femoral neck area.The patient was transferred to the recovery room in stable condition.

Manufacturer Narrative

H3, h6.It was reported that a right hip revision surgery was performed.As of today, device return has been requested for this complaint but has not become available.As no device batch numbers were provided for investigation for the femoral head, a manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the femoral head.A review of historical complaints data was performed 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.Other similar complaints have been identified for the part number and the reported failure mode, and this failure will continue to be monitored.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.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.The reported pain, leg length discrepancy, and subsequent revision are related to the impingement and avascular necrosis.It cannot be concluded that the reported events/clinical reactions were associated with a mal performance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the information provided, we can confirm this complaint; a probable root cause of the reported issues is the impingement on the acetabular component and avascular necrosis of the femoral neck and not the device.Should the devices or additional information be received, the complaint will be reopened.Based on the investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: RESURFACING FEMORAL HEAD 50MM
• 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: 14030394
• MDR Text Key: 288794268
• Report Number: 3005975929-2022-00127
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74121150
• Device Catalogue Number: 74121150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• 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
• Treatment: ACETLR CUP HAP 56MM W/ IMPTR
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male