MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120154
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal refrence number: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Bourget-murray j, watt kearns sj, piroozfar s, lukenchuk j, johnston k, werle j.Birmingham hip resurfacing for osteoarthritis - a canadian retrospective cohort study with a minimum 10-year follow-up.Can j surg.2022 may 3;65(3):e296-e302.Doi: 10.1503/cjs.013320.
Event or Problem Description
It was reported that on literature review "birmingham hip resurfacing for osteoarthritis ¿ a canadian retrospective cohort study with a minimum 10-year follow-up", after a bhr resurfacing surgery performed due to osteoarthritis, patient experienced cup loosening.This adverse event was treated with a revision surgery to a bhr dysplasia cup 97 months after implantation.No further information is available.
Additional Manufacturer Narrative
It was reported that on literature review "birmingham hip resurfacing for osteoarthritis ¿ a canadian retrospective cohort study with a minimum 10-year follow-up", after a bhr resurfacing surgery performed due to osteoarthritis, patient experienced cup loosening.This adverse event was treated with a revision surgery.The devices, used in treatment were not available for evaluation.A review of the complaint history for the cup was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.No other similar complaints were identified.Without batch numbers a review of the manufacturing records could not be performed.Should the details be received at a later date this task will be reopened and completed.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 quality escalations 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.It is noted, no further information is available.As of the date of this medical investigation, clinically relevant patient-specific supporting documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported events.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The patient¿s outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.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.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: ACETLR CUP HAP 54MM 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: 16820483
• Report Number: 3005975929-2023-00056
• Device Sequence Number: 17925126
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 3596010502582
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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: 74120154
• Device Lot Number: UNKNOWN
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 74121146/RESURFACING FEMORAL HEAD 46MM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female