MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74122150
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	High metal ion levels (4847)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after undergoing a left bhr-tha on (b)(6) 2009, the patient was diagnosed with elevated metal ion levels on or about (b)(6) 2024.Therefore, they are scheduled for a revision surgery on (b)(6) 2024.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H3, h6: it was reported that, after undergoing a left bhr-total hip arthroplasty the patient was diagnosed with elevated metal ion levels.Therefore, they are scheduled for a revision surgery.Patient's current health status is unknown.As of today, the devices, all of which were used in treatment, remain implanted and therefore cannot be tested.A review of the historical complaints data for the alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Other similar complaints were identified for the cup and none for the head and sleeve.This will continue to be monitored via routine trending, however it should be noted that this device is no longer sold.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.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, 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.Based on the limited information provided the clinical root cause of the reported elevated metal ions, cannot be confirmed.The patient impact is determined to be the elevated metal ions and scheduled revision.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: ACETABULAR CUP HAP SIZE 44/50
• 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: 19655033
• Report Number: 3005975929-2024-00093
• Device Sequence Number: 20519475
• Product Code: NXT
• UDI-Device Identifier: 03596010552273
• UDI-Public: 3596010552273
• 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: 2009
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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 Expiration Date: 09/29/2013
• Device Catalogue Number: 74122150
• Device Lot Number: 08JW18863
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2008
• 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: 71357004/ANTHOLOGY SO POR PL HA SZ 4/ LOT: 08MM115; 74122544/HEMI HEAD44MM/LOT: 08CW16088; 74222100/MODULAR SLEEVE -4MM 12/14/ LOT: 08EW16959
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female