MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-0637
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's hip was revised due to trunnion wear and dissociation of the head from the stem.Rep was not present for the procedure.The stem, head and liner were revised.
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.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.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and crack/fracture involving an accolade stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: device 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 records by a clinical consultant stated the following comment: : i have had the opportunity to review documentation related to the pi including the product inquiry summary, as well as implant records from the index surgery dated (b)(6)2012 and the revision surgery dated (b)(6) 2022.The event description from the product inquiries summary states: it was reported that the patient's hip was revised due to trunnion wear and dissociation of the head from the stem.Rep was not present for the procedure.The stem, head and liner were revised.Rep may be able to provide pictures and implant information.Otherwise, no further information will be released by the hospital or surgeon.The ap pelvis x-ray demonstrates the femoral head of the right tha has dissociated from the femoral stem.There is substantial material loss from the trunnion with "pencil" remodeling of the trunnion.The x-ray confirms dissociation of the head from the femoral stem.The implant records confirm a primary hip implanted in 2012 and a revision surgery occurred in 2022.However, the implant record from 2022 is incomplete as sheet only shows a liner was used.In light of the extensive damage to the index stem this is not feasible.The root cause of this mechanical complication it is confirmed that a fracture through the neck of a cemented femoral stem has occurred.The root cause of this mechanical complication cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment.Device 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.Conclusion: no further investigation is required at this time.If additional information becomes 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 and dissociation of the head from the stem.Rep was not present for the procedure.The stem, head and liner were revised.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #6
• 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: 15705704
• Report Number: 0002249697-2022-01576
• Device Sequence Number: 12419841
• Product Code: LPH
• UDI-Device Identifier: 04546540510716
• UDI-Public: 04546540510716
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/16/2023

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: 09/30/2016
• Device Model Number: 6021-0637
• Device Catalogue Number: 6021-0637
• Device Lot Number: 37797106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2011
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 103 KG