MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0435
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to the trunnion breaking off from the stem (reported as 'right at the beginning of the trunnion) inside the head.The head, stem, and liner were revised.
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's right hip was revised due to the trunnion breaking off from the stem (reported as 'right at the beginning of the trunnion) inside the head.The head, stem, and liner were revised.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a accolade stem was reported.The event was confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records by a clinical consultant indicated "the ap pelvis x-ray shows a pressfit right tha where the head has dissociated from the trunnion.The trunnion itself is deformed with significant material loss superiorly and rounding off of the trunnion.In addition, there is a fracture of the inferior portion of the trunnion.Fracture of the trunnion with trunnion deformation and head dissociation is confirmed.The root cause of this issue cannot be established by the limited documentation provided.Should additional information become available i would be happy to further this assessment.-product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no similar events for the lot referenced.Conclusion: it was reported the patient was revised due to stem fracture and head disassociation.A review of medical records by a clinical consultant indicated "the ap pelvis x-ray shows a pressfit right tha where the head has dissociated from the trunnion.The trunnion itself is deformed with significant material loss superiorly and rounding off of the trunnion.In addition, there is a fracture of the inferior portion of the trunnion.Fracture of the trunnion with trunnion deformation and head dissociation is confirmed.The root cause of this issue cannot be established by the limited documentation provided.Should additional information become available i would be happy to further this assessment.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE TMZF HIP STEM #4
• 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, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 14826747
• Report Number: 0002249697-2022-00921
• Device Sequence Number: 19996650
• Product Code: LPH
• UDI-Device Identifier: 04546540510563
• UDI-Public: 04546540510563
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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: 06/30/2015
• Device Model Number: 6020-0435
• Device Catalogue Number: 6020-0435
• Device Lot Number: 33875303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2010
• 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 Sex: Male