MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0335
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by patient's counsel as a result of a legal claim that allegedly the patient underwent right tha on (b)(6) 2013, and was implanted with an lfit v40 femoral head and accolade hip stem requiring revision surgery on (b)(6) 2022, due to alleged head disassociation.
Additional Manufacturer Narrative
An event involving an unknown accolade stem regarding disassociation and wear was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: not performed as the lot number was not provided.-complaint history review: not performed as the lot number was not provided.Conclusions: it was reported that the patient was revised due to disassociation.The exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Additional Manufacturer Narrative
An event involving an accolade stem regarding disassociation and wear was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to disassociation.The exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported by patient's counsel as a result of a legal claim that allegedly the patient underwent right tha on april 8, 2013, and was implanted with an lfit v40 femoral head and accolade hip stem requiring revision surgery on may 6, 2022, due to alleged head disassociation.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19488961
• Report Number: 0002249697-2024-00844
• Device Sequence Number: 17914698
• Product Code: LPH
• UDI-Device Identifier: 04546540510686
• UDI-Public: 04546540510686
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 03/31/2017
• Device Catalogue Number: 6021-0335
• Device Lot Number: 39496701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2012
• 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: Hospitalization; Required Intervention
• Patient Sex: Male