MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6021-0637
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to trunnionosis.Surgeon also reported that the shell was not anteverted properly, causing impingement of the liner and stem.An accolade stem, 40mm femoral head, and liner were revised to competitor femoral implants and a new stryker liner.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving an accolade stem was reported.The event was confirmed via med review.Method & results: product evaluation and results: visual inspection: the device was not returned; however, photographs were provided for review.These images clearly show the device in a disassociated and used state, with significant wear evident on the trunnion, and typical wear patterns from implantation and explantation.Based on this evidence, the event can be confirmed clinician review: a review of the provided medical records by a clinical consultant indicated:" i can confirm that the patient had a right total hip arthroplasty which developed trunnionosis/head neck disassociation since i was able to review an x-ray demonstrating the problem and failure.Unfortunately there were no demographics or any markings on the x-ray.It was a right total hip arthroplasty if conventional orientation was utilized.I cannot confirm that the patient had a revision because i have no documentation including office notes, operation notes or post revision radiographs.The root cause of this event cannot be determined with certainty.The causes of trunnionosis with head neck disassociation are multifactorial including surgical technique, especially in the way that the femoral head and trunnion are prepared for insertion and the way in which the femoral head is inserted on the femoral trunnion.Also importantly it was noted that the acetabular component was not anteverted properly causing impingement of the liner and stem.This can certainly contribute to the event.Other factors including the patient's lifestyle, activity level and bmi also contributes.Implant factors may also the contributory.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: no other similar events were reported for the lot conclusions: it was reported that the patient was revised due to disassociation and wear.The device was not returned; however, photographs were provided for review.These images clearly show the device in a disassociated and used state, with significant wear evident on the trunnion, and typical wear patterns from implantation and explanation.A review of the provided medical records by a clinical consultant indicated:" i can confirm that the patient had a right total hip arthroplasty which developed trunnionosis/head neck disassociation since i was able to review an x-ray demonstrating the problem and failure.Unfortunately there were no demographics or any markings on the x-ray.It was a right total hip arthroplasty if conventional orientation was utilized.I cannot confirm that the patient had a revision because i have no documentation including office notes, operation notes or post revision radiographs.The root cause of this event cannot be determined with certainty.The causes of trunnionosis with head neck disassociation are multifactorial including surgical technique, especially in the way that the femoral head and trunnion are prepared for insertion and the way in which the femoral head is inserted on the femoral trunnion.Also importantly it was noted that the acetabular component was not anteverted properly causing impingement of the liner and stem.This can certainly contribute to the event.Other factors including the patient's lifestyle, activity level and bmi also contributes.Implant factors may also the contributory.Based on this evidence, the event can be confirmed.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 PLUS TMZF HIP STEM #6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20636834
• Report Number: 0002249697-2024-01526
• Device Sequence Number: 7404309
• Product Code: JDI
• UDI-Device Identifier: 04546540510716
• UDI-Public: 04546540510716
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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: 02/29/2016
• Device Catalogue Number: 6021-0637
• Device Lot Number: 36006501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2011
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 113 KG