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

Catalog Number 74121146

Device Problem Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Joint Laxity (4526)

Event Date 06/15/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a bhr surgery, the resurfacing femoral head 46mm loosened in the femur so it was revised on (b)(6) 2022 with a bhr dual mobility and a stem.Current health status of the patient is unknown.

Manufacturer Narrative

D4 and h4 were corrected.

Manufacturer Narrative

Section d4 was updated.

Manufacturer Narrative

Additional information added: h6 (component code, type of investigation, investigation findings, investigation conclusions).H9: z-2745-2015 through z-2747-2015.Results of investigation: it was reported that revision of the femoral head component was performed due to loosening.As of today, the device, used in treatment, has not been returned for evaluation and further information has not been supplied in relation to the case.A review of the historical complaints data for the femoral head was performed.One other complaint was identified involving this batch number.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 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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.No details have been supplied to enable an evaluation of the case from a clinical / medical perspective.Based on the information provided we cannot confirm or further investigate the reported complaint, our 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 additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.Corrected data: h3, h6(health effect - clinical code, health effect - impact code).

• 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: 14933209
• MDR Text Key: 295345916
• Report Number: 3005975929-2022-00415
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74121146
• Device Lot Number: 089778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2267-2018, Z-2268-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female