MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74121154
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after a bhr surgery on (b)(6) 2007, the patient presented high co and cr levels.The adverse event was treated via revision surgery on (b)(6) 2022 and the resurfacing femoral head 54mm was explanted.Patient current status is unknown.
Additional Manufacturer Narrative
B5: describe event or problem.B6: relevant tests/laboratory data, including dates.
Event or Problem Description
It was reported that after a bhr surgery on (b)(6) 2007, the patient presented high co and cr levels.The adverse event was treated via revision surgery on (b)(6) 2022 and the resurfacing femoral head 54mm was explanted.The patient is doing well.
Additional Manufacturer Narrative
H3, h6: it was reported that revision surgery of the 54mm resurfacing femoral head was performed due to elevated metal ion levels.The device, used in treatment, was not returned for analysis.As no device lot numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.Similar complaints were identified for the femoral head part number and the reported failure mode.This will continue to be monitored.If more information is received, this investigation will be reopened.A review of historic escalation actions related to the products 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.A risk management review was performed for the devices involved.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.Based on the reported symptoms it cannot be concluded that the events/clinical reactions of high cobalt and chromium levels was associated with a mal-performance of the implant.The patient impact cannot be determined at this time.No further clinical assessment is warranted at this time.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: RESURFACING FEMORAL HEAD 54MM
• 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: 13958249
• Report Number: 3005975929-2022-00089
• Device Sequence Number: 5053561
• Product Code: NXT
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• 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: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74121154
• Device Catalogue Number: 74121154
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 04/12/2022; 06/27/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/21/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 89 KG