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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
It was reported that the patient arrived in er with discomfort in hip.Component failure discovered upon xray.The head disassociated from the stem.
Event or Problem Description
It was reported that the patient arrived in er with discomfort in hip.Component failure discovered upon xray.The head disassociated from the stem.
Additional Manufacturer Narrative
An event regarding disassociation involving an accolade stem that was mated with a lfit v40 cocr head was reported.The event was confirmed via clinician review of provided medical records and evaluation of the provided photographs of the devices.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show the trunnion of the stem is severely worn.Damage is consistent with loss of taper lock.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this product inquiry concerns a male patient who underwent a right total hip arthroplasty with a cobalt chrome femoral head with an accolade stem.The patient developed had neck disassociation with trunnionosis.I can confirm that the patient underwent both primary and revision surgeries since i was able to review the x-rays.I can also confirm that trunnionosis and trunnion deformity was present since i was able to see intraoperative photos displaying those findings.The root cause of this event cannot be determined with certainty.The causes of trunnionosis and head neck disassociation are multifactorial including surgical technique factors, especially in the preparation, or lack thereof, of the femoral head and trunnion prior to final insertion.Other factors include patient activity level and bmi as well as implant factors." 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: the reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17854890
• Report Number: 0002249697-2023-01092
• Device Sequence Number: 3390563
• Product Code: LPH
• UDI-Device Identifier: 04546540510761
• UDI-Public: 04546540510761
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: 11/30/2016
• Device Catalogue Number: 6021-4535
• Device Lot Number: 38403904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2011
• 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 Age: 72 YR
• Patient Sex: Male