MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 46MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120146
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).(b)(6).
Event or Problem Description
It was reported that, after a thr surgery, it was necessary to perform a revision surgery in which an acetlr cup hap 46mm w/ imptr was explanted; however, it is unknown the reason that led to this surgery.The current health status of the patient is also unknown.
Additional Manufacturer Narrative
It was reported that a hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Since part/lot details were not received for investigation for the femoral head implant, no thorough manufacturing record review or assessment of the reported event can be performed.If the products or additional information become available in the future, the tasks will be reopened and performed.A review of the historical complaints data for the acetabular cup 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.No other similar complaints were identified to involve this batch.Other similar complaints have been identified for the part number and the reported failure mode.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the 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.Bhr resurfacing systems =46mm have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.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 required.Smith and nephew has not received relevant clinical documentation or the device to perform a thorough medical investigation nor can we determine a definitive root cause of the reported failure.Per the medical director¿s analysis of the three prevision x-ray photos, two of which were undated and unlabeled, along with one x-ray photo dated 8-2-2021, the provided x-rays revealed, ¿edge loading and osteolysis of the acetabulum behind the shell¿ likely loose shell.¿ based on the information provided, this patient underwent a revision where the acetabulum component was removed and replaced with a redapt.Without the requested supporting clinical documentation, we are unable to determine when the onset of loosening occurred or if the length of time in that position could have caused and/or contributed to other metal related injuries.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this compliant would be re-assessed.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm 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.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: ACETLR CUP HAP 46MM W/ IMPTR
• 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: 12741798
• Report Number: 3005975929-2021-00492
• Device Sequence Number: 4012469
• Product Code: NXT
• UDI-Device Identifier: 03596010502544
• UDI-Public: 3596010502544
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 74120146
• Device Lot Number: 26259
• 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: 10/12/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 02/28/2022
• 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: Other
• Patient Sex: Unknown