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

Model Number	6021-0335
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's hip was revised due to trunnion wear.The stem, head, and liner were revised to a restoration modular stem construct, femoral head, and liner.Rep confirmed that there are no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving an accolade stem was reported.The events were confirmed through evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the trunnion of the stem was worn.Damage is consistent with the loss of taper lock.Dimensional inspection and functional inspection was not performed as the device was returned damaged.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.-clinician review: no medical records were received for review with a clinical consultant.-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: the device was returned for evaluation.Damage/wear is visible on the stem trunnion.Biological matter is visible on the stem body.Material evaluation was completed and indicated the following comments: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.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.
Event or Problem Description
It was reported that the patient's hip was revised due to trunnion wear.The stem, head, and liner were revised to a restoration modular stem construct, femoral head, and liner.Rep confirmed that there are no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.

• Brand Name: ACCOLADE PLUS 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 14389819
• Report Number: 0002249697-2022-00690
• Device Sequence Number: 14739788
• Product Code: LPH
• UDI-Device Identifier: 04546540510686
• UDI-Public: 04546540510686
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 10/31/2016
• Device Model Number: 6021-0335
• Device Catalogue Number: 6021-0335
• Device Lot Number: 38252402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2011
• 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: 73 YR
• Patient Sex: Male