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

Catalog Number	6021-0435
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving an accolade stem was reported.The events 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 the provided medical information by a clinical consultant indicated: it was reported that the patient's left hip was revised.As reported: "the revision was secondary to pain from dislocation.The dislocation was identified radiographically to have occurred between the femoral stem and femoral head.No further information is available from the doctor or hospital." the x-ray of a pressfit tha sows it is anatomic position without evidence of loosening.The femoral head gas disassociated from the femoral stem.There is remodeling of the superior aspect of the trunnion with material loss.Disassociation of a femoral head from a femoral stem in a tha is confirmed.No documentation was provided to confirm this tha was revised.The root cause of this tha disassociation cannot be determined from 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 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.A review of the provided medical information by a clinical consultant indicated: "it was reported that the patient's left hip was revised.As reported: "the revision was secondary to pain from dislocation.The dislocation was identified radiographically to have occurred between the femoral stem and femoral head.No further information is available from the doctor or hospital." the x-ray of a pressfit tha sows it is anatomic position without evidence of loosening.The femoral head gas disassociated from the femoral stem.There is remodeling of the superior aspect of the trunnion with material loss.Disassociation of a femoral head from a femoral stem in a tha is confirmed.No documentation was provided to confirm this tha was revised.The root cause of this tha disassociation cannot be determined from the limited documentation provided.Should additional information become available i would be happy to further this assessment." further information such as return of the device, pathology reports, pre- and post-operative x-rays, and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.Product surveillance will continue to monitor for trends.
Event or Problem Description
It was reported that the patient's left hip was revised.As reported: "the revision was secondary to pain from dislocation.The dislocation was identified radiographically to have occurred between the femoral stem and femoral head.No further information is available from the doctor or hospital.".

• Brand Name: ACCOLADE PLUS 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: kelsey williams ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18062218
• Report Number: 0002249697-2023-01317
• Device Sequence Number: 20699292
• Product Code: LPH
• UDI-Device Identifier: 04546540510693
• UDI-Public: 04546540510693
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

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: 08/31/2020
• Device Catalogue Number: 6021-0435
• Device Lot Number: 52370206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• 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: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male