MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6020-4535
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient revised for failure of left total hip arthroplasty.Gray tissue staining.Dissociated head and stem trunnion damage were noted.Stem and head were explanted and replaced with new stem (below billing sheet).Cup and insert were retained.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving a accolade stem was reported.The event was confirmed via review of the provided photographs.Method & results: -product evaluation and results: the device was not returned; however, photographs were provide for review.The photographs show a recently explanted head, some biological material is noted outside and inside the implant.There is also an intraop photo where the stem is shown to be completely disassociated from the stem.Loos of taper lock is confirmed.-clinician review: a review with a clinical consultant indicated " i can confirm that the patient had a primary left total hip arthroplasty with head neck disassociation and trunnion deformity inside was able to review and x-ray showing those findings.I can confirm that the patient had revision surgery by way of the implant usage sheet for the revision procedure although i do not have a copy of the operation report, nor do i have any post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of head neck disassociation with trunnionosis are multifactorial including surgical technique especially in the way that the trunnion and femoral head are prepared and implanted, positioning of the implants to avoid impingement, patient factors including lifestyle, 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: it was reported that the patient was revised due to disassociation of the head from the stem and trunnionsosis.The device was not returned; however, photographs were provide for review.The photographs show a recently explanted head, some biological material is noted outside and inside the implant.There is also an intraop photo where the stem is shown to be completely disassociated from the stem.Loos of taper lock is confirmed.A review with a clinical consultant indicated " i can confirm that the patient had a primary left total hip arthroplasty with head neck disassociation and trunnion deformity inside was able to review and x-ray showing those findings.I can confirm that the patient had revision surgery by way of the implant usage sheet for the revision procedure although i do not have a copy of the operation report, nor do i have any post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of head neck disassociation with trunnionosis are multifactorial including surgical technique especially in the way that the trunnion and femoral head are prepared and implanted, positioning of the implants to avoid impingement, patient factors including lifestyle, activity level, and bmi, as well as implant factors.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.
Event or Problem Description
Patient revised for failure of left total hip arthroplasty.Gray tissue staining.Dissociated head and stem trunnion damage were noted.Stem and head were explanted and replaced with new stem (below billing sheet).Cup and insert were retained.

• Brand Name: ACCOLADE 132 SIZE 4.5
• 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: 19994421
• Report Number: 0002249697-2024-01129
• Device Sequence Number: 7057731
• Product Code: JDI
• UDI-Device Identifier: 04546540510631
• UDI-Public: 04546540510631
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 04/30/2016
• Device Catalogue Number: 6020-4535
• Device Lot Number: 36406801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2011
• 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: 76 YR
• Patient Sex: Male