MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-4535
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving accolade stem was reported.The event was not confirmed.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including lot 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.H3 other text : device not returned.
Event or Problem Description
It was reported by patient's attorney as a result of a legal claim that the patient was implanted with an accolade tmzf hip stem and lfit anatomic v40 femoral head on his right hip on or about (b)(6) 2009.It is alleged that he developed severe pain in the right hip and the inability to walk or bear weight on the right leg, trunnionosis, almost complete disassociation between the femoral head and neck, and a metallosis.He was revised on (b)(6) 2022.

• Brand Name: ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17763939
• Report Number: 0002249697-2023-01049
• Device Sequence Number: 17956151
• Product Code: LPH
• UDI-Device Identifier: 04546540510761
• UDI-Public: 04546540510761
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2023

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: 02/28/2014
• Device Catalogue Number: 6021-4535
• Device Lot Number: 29091202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2009
• 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: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male