MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #5; REP CALLED TO INFORM OF A BROKEN ACCOLADE TRUNNION IN A CASE OVER THE WEEKEND. W

Catalog Number	6021-0537
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	05/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Rep called to inform of a broken accolade trunnion in a case over the weekend.This was a revision surgery.Primary surgery was on (b)(6) 2014.
Additional Manufacturer Narrative
An event regarding disassociation & crack/fracture involving an accolade stem that was mated with a lfit v40 cocr head was reported.The event was confirmed.Method & results: -device evaluation and results: the reported devices were not returned but photographs were provided for review.A review indicated recently explanted devices covered in blood.The head had what looked like black debris on the inner taper.Loss of taper lock between the head neck junction and the trunnion of the stem was fractured.The liner had damage consistent with explantation -clinician review: a review of the provided medical records by a clinical consultant indicated: "the ap and lateral x-rays show a press fit th with a head dissociated from a deformed trunnion.The photograph demonstrates significant metallosis within the hip.A head dissociation from a trunnion with significant material loss is confirmed.The root cause of this mechanical complication cannot be determined from the limited documentation provided.-device 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.Conclusion: the reported devices were not returned but photographs were provided for review.A review indicated recently explanted devices covered in blood.The head had what looked like black debris on the inner taper.Loss of taper lock between the head neck junction and the trunnion of the stem was fractured.The liner had damage consistent with explantation.A review of the provided medical records by a clinical consultant indicated: "the ap and lateral x-rays show a press fit th with a head dissociated from a deformed trunnion.The photograph demonstrates significant metallosis within the hip.A head dissociation from a trunnion with significant material loss is confirmed.The root cause of this mechanical complication cannot be determined from the limited documentation provided.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.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
Rep called to inform of a broken accolade trunnion in a case over the weekend.This was a revision surgery.Primary surgery was (b)(6) 2014.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #5
• Common Device Name: REP CALLED TO INFORM OF A BROKEN ACCOLADE TRUNNION IN A CASE OVER THE WEEKEND. W
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19526547
• Report Number: 0002249697-2024-00877
• Device Sequence Number: 7501588
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 08/31/2018
• Device Catalogue Number: 6021-0537
• Device Lot Number: 42911306
• 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: 05/25/2024
• Supplement Date Received by Manufacturer: 08/17/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2013
• 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: 89 YR
• Patient Sex: Unknown