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

Model Number	74121150
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); High metal ion levels (4847)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after a bhr surgery was performed on (b)(6) 2010, the patient experienced high levels of lead.On (b)(6) 2022 an mri showed damage had to be removed.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H11: corrected information in h6 (health effect - clinical code and health effect - impact code).
Event or Problem Description
It was reported that, after undergoing left hip bhr resurfacing on (b)(6) 2010 due to unspecified complications caused by high impact activities (construction work), the patient experienced high levels of lead and cobalt.On (b)(6) 2022, an mri revealed a faulty hip construct and coexistent metal shavings.This event was treated by performing a revision surgery on (b)(6) 2023.
Additional Manufacturer Narrative
It was reported that a left hip revision surgery was performed because the patient experienced high levels of lead and cobalt and a faulty hip construct.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head and the cup, and this failure will continue to be monitored.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the cup.In the absence of the actual devices, the production records were reviewed for the head reportedly involved in this incident.The cup involved met manufacturing specifications upon release for distribution.As no device batch numbers were provided for investigation for the cup, the manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The 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.Although the increased cobalt levels and mri results of ¿faulty hip¿ were reported, the cobalt level values and/or laboratory reports as well as the mri imaging were not provided for review.Therefore, based on the limited information provided, there were no clinical factors found which would have contributed to the reported high cobalt levels and mri results.The patient impact beyond the revision surgery could not be determined.Although high levels of lead and cobalt were reported by the patient, lead is not a constituent of bhr devices and we believe this to be an error.Bhr devices comply with iso 5832-4:2014, related to cobalt-chromium-molybdenum casting alloy.Composition of bhr devices are provided with every castings batch which confirm no notable levels of lead are present.Batch numbers were not provided for investigation of the cup.The chemical composition breakdown of the femoral head castings batch shows no notable levels of lead are present.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.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
• 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: 16808546
• Report Number: 3005975929-2023-00030
• Device Sequence Number: 20331673
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2023

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 Expiration Date: 03/30/2015
• Device Model Number: 74121150
• Device Catalogue Number: 74121150
• Device Lot Number: 10CW26199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 05/31/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/25/2023; 05/31/2023
• Date Device Manufactured: 03/31/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 74120156 / ACETLR CUP HAP 56MM W/ IMPTR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male