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 Hip Fracture (2349); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 05/15/2021

Event Type  Injury  

Event Description

It was reported that, after left bhr surgery was performed on (b)(6) 2006, the patient experienced periprosthetic left femoral neck fracture, pain and inability to ambulate.This adverse event was treated with a revision surgery on (b)(6) 2021, in which severe arthritic degeneration of both the femoral head and the acetabular articular surfaces was observed.The patient's current status is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

D4, h4, h3, h6: it was reported that the patient experienced periprosthetic left femoral neck fracture, pain and inability to ambulate.This adverse event was treated with a revision surgery, in which severe arthritic degeneration of both the femoral head and the acetabular articular surfaces was observed.The patient's current status is unknown and the devices, used in treatment, were not returned for analysis.A review of the historical complaints data for the devices was performed, using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and 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.No other similar complaints were identified involving the femoral head batch.One complaint was found for the acetabular cup batch.Other similar complaints have been identified for the part numbers and the reported failure mode; this failure will continue to be monitored.In the absence of the actual devices, 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 products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20 degrees of anteversion and 40-45 degrees of abduction.However, the revision operative report indicates that the acetabular component was noted to be excessively anteverted and showed signs of migration for its original placement.It is unknown if this position and migration of the acetabular component has led to accelerated wear and the reported pain and intraoperative findings of discolored synovial fluid, femoral neck fracture, and cavitary defects of the acetabulum.The severe arthritic degeneration of the femoral head and acetabular surfaces cannot be ruled out as a contributing factor to the reported pain.The patient impact beyond that which has already been reported cannot be determined.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.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, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this 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: 14493957
• MDR Text Key: 292574875
• Report Number: 3005975929-2022-00334
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2011
• Device Model Number: 74121150
• Device Catalogue Number: 74121150
• Device Lot Number: 61891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Date Device Manufactured: 04/21/2006
• 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 Age: 55 YR
• Patient Sex: Male