MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74121142
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Discomfort (2330); High metal ion levels (4847)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a left hip bhr procedure performed on (b)(6) 2012, the plaintiff suffered from elevated metal ion levels in blood and occasional plunking sensations in the left hip.No revision surgery or medical intervention has been indicated at this time to address the issue, however, the level of cobalt in blood suppresses the safety limit.The current state of heath of the patient is unknown.
Additional Manufacturer Narrative
It was reported that, after a left hip bhr procedure the bilateral plaintiff suffered from elevated metal ion levels in blood and occasional plunking sensations in the left hip.The devices, used in treatment, remain implanted.A review of the historical complaints data for the devices involved 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.One other complaint was identified to involve the acetabular cup batch.Other similar complaints were identified for both part numbers and the reported/related failure mode.This will continue to be monitored via routine trending, however it should be noted that the parts are no longer sold.In the absence of the actual devices, the production records were reviewed for the devices involved.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.Prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.With the information provided the clinical root cause of the reported elevated cobalt cannot be confirmed.It cannot be concluded the reported elevated cobalt was associated with a mal performance of the implant or implant failure.Based on the available 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 42MM
• 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: 16527358
• Report Number: 3005975929-2023-00016
• Device Sequence Number: 14108424
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 3596010502773
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 74121142
• Device Lot Number: 085568
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/12/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2745-2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 52 KG