MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6020-0335
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	10/18/2024
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.
Event or Problem Description
Accolade tmzf with 36 metal head.Femoral stem trunnion worn down.Hospital took implants and was doing testing.
Event or Problem Description
Accolade tmzf with 36 metal head.Femoral stem trunnion worn down.Hospital took implants and was doing testing.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an accolade stem was reported.The event was confirmed via evaluation of the provided photographs of the stem and clinician review of the provided medical records.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the stem indicated damage consistent with loss of taper lock.-clinician review: a review with a clinical consultant indicated "i can confirm that the patient underwent a primary left total hip arthroplasty at some point in the past, on or about (b)(6), 2014 since i was able to review an undated photo with the implant in place.The acetabular component did appear anteverted and subsequently the trunnion was deformed and there was a significant notch on the inferior aspect of the femoral neck.I can also confirm that the patient underwent a revision procedure on (b)(6), 2024 since i was able to see the explanted prosthetic components with deformity of the trunnion and a notch in the inferior portion of the neck of the femoral stem.It is unclear whether the acetabular component was revised or left in situ.I do not have either the primary or the revision operation report.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to disassociation of the femoral head from the stem.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the stem indicated damage consistent with loss of taper lock.A review with a clinical consultant indicated "i can confirm that the patient underwent a primary left total hip arthroplasty at some point in the past, on or about (b)(6), 2014 since i was able to review an undated photo with the implant in place.The acetabular component did appear anteverted and subsequently the trunnion was deformed and there was a significant notch on the inferior aspect of the femoral neck.I can also confirm that the patient underwent a revision procedure on (b)(6), 2024 since i was able to see the explanted prosthetic components with deformity of the trunnion and a notch in the inferior portion of the neck of the femoral stem.It is unclear whether the acetabular component was revised or left in situ.I do not have either the primary or the revision operation report.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 TMZF HIP STEM #3
• 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: 20598126
• Report Number: 0002249697-2024-01500
• Device Sequence Number: 6529009
• Product Code: JDI
• UDI-Device Identifier: 04546540510556
• UDI-Public: 04546540510556
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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 Catalogue Number: 6020-0335
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Female