MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122158
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Shaking/Tremors (2515); Metal Related Pathology (4530)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a primary left bhr tha surgery performed on (b)(6) 2011, the plaintiff experienced ringing in his ears, tremor, severe pain, and evidence of osteolysis in the acetabulum, so he underwent a left hip revision surgery on (b)(6) 2022.During the revision, a huge amount of metallosis was found.The acetabular cup hap size 52/58, hemi head 52mm and the modular sleeve -4mm 12/14 were explanted and replaced with components from a competitor manufacturer (stryker).The syn por fem comp sz 15 remained implanted.Patient current health status is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that, after a primary left bhr tha surgery performed, the plaintiff experienced ringing in his ears, tremor, severe pain, and evidence of osteolysis in the acetabulum, so so a left hip revision surgery was performed.The devices, used in treatment, were not returned for evaluation.A review of the complaint history for the head cup and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes 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 reopen date.Similar complaints have been identified for the cup and failure mode and this will continue to be monitored through routine complaint trending.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic capa/nc/pra/hhe/field 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 required.The available medical documents were reviewed.With the limited information provided the clinical root cause of the reported ringing in his ears, tremor, severe pain, and metallosis cannot be confirmed.It cannot be concluded the reported events / clinical reactions were associated with a mal performance of the implant or implant failure.The patient impact beyond the reported events cannot be determined based on the information provided we cannot further investigate the complaint 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.If the products or additional information become available in the future, this case will be reopened.Based on this investigation the need for corrective and preventative action is not indicated.

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• 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: 16542394
• Report Number: 3005975929-2023-00017
• Device Sequence Number: 15018975
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• 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: 2011
• Device Explanted Year: 2022
• 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): 04/13/2023

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 Expiration Date: 09/29/2015
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 10JW30127
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/13/2023
• Date Device Manufactured: 09/30/2010
• 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: 71306615 / UNKNOWN; 74122552 / 09BW22111; 74222100 / 10CW2552
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male