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

Model Number	6020-0335
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 trunnion-head of the accolade tmzf stem failed and required revision.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an accolade stem which was mated with a lfit v40 cocr head was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the trunnion of the stem was severely worn.Damage is consistent with the loss of taper lock.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the implant record confirms it was a tmzf stem matched with a v40 lfit head.Radiographs confirm tha failure with dissociation of the femoral head from the stem.The trunnion is deformed with inferomedial notching and material loss.There is also rounding off of the superior aspect of the trunnion.Similar findings are noted on the intra-operative photograph.It is confirmed that there was a need for revision of a femoral head neck tha dissociation and that the trunnion was deformed and suffered material loss.Acetabular reviosn can ot be confirmed due to lack of documentation.The root cause of the dissociation and femoral stem trunnion deformity cannot be established by this limited documentation." -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 failure of the stem trunnion.The event was confirmed by medical review and examination of the returned devices.Visual inspection indicated that damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the trunnion-head of the accolade tmzf stem failed and required revision.(b)(6), 2021: pictures revealed that the shell was also revised.

• Brand Name: ACCOLADE TMZF HIP STEM #3
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12959878
• Report Number: 0002249697-2021-02020
• Device Sequence Number: 20189646
• Product Code: LPH
• UDI-Device Identifier: 04546540510556
• UDI-Public: 04546540510556
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: 05/31/2012
• Device Model Number: 6020-0335
• Device Catalogue Number: 6020-0335
• Device Lot Number: 22108701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2007
• 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: 88 YR
• Patient Sex: Female