MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-0230
Medical Device Problem Codes	Degraded (1153); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	01/12/2021
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.Catalog numbers and lot codes of other devices listed in this report: cat # mac-9988-4854, lot # rm061631, description: std mitch trh cp sz 48/54, manufacturer: depuy.Cat # mmh-9988-0048, lot # fm063623, description: mitch trh md hd sz 48+0, manufacturer: depuy.
Event or Problem Description
It was reported that the patient had tha in 2008 at another facility out of town.The patient presented with stem fx and pain and xrays showed fx and some metal on metal inducing pseudotumor.The patient required a revision of the femoral stem.
Additional Manufacturer Narrative
An event regarding disassociation, altr and wear involving a accolade stem was reported.The event of disassociation and wear were confirmed, the event of altr was not 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 records by a clinical consultant stated the following comment: ap pelvis x-rays x2, both undated, one with side label.Showed head disengaged from stem with severe trunnion wear, second x-ray with apparent repair.Event confirmation: there was head disengagement and severe trunnion wear of a tmzf accolade stem.Root cause: the root cause cannot be determined without additional medical and radiographic information and potentially the explants.Identifying the implant lot numbers would be an important step to root cause relative to the trunnion failure.Product history review: indicated all 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: a review of the provided medical records by a clinical consultant stated the following comment: ap pelvis x-rays x2, both undated, one with side label.Showed head disengaged from stem with severe trunnion wear, second x-ray with apparent repair.Event confirmation: there was head disengagement and severe trunnion wear of a tmzf accolade stem.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, histopathology report, pre- and post-operative x-rays, primary 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.
Event or Problem Description
It was reported that the patient had tha in 2008 at another facility out of town.The patient presented with stem fx and pain and xrays showed fx and some metal on metal inducing pseudotumor.The patient required a revision of the femoral stem.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11269403
• Report Number: 0002249697-2021-00199
• Device Sequence Number: 1167048
• Product Code: LPH
• UDI-Device Identifier: 04546540510679
• UDI-Public: 04546540510679
• 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: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 01/31/2021
• Device Model Number: 6021-0230
• Device Catalogue Number: 6021-0230
• Device Lot Number: 21426001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 46