MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-0537
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); No Information (3190)
Date of Event	11/18/2020
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
As reported: "revision of left hip due to fractured femoral stem at head neck junction of trunnion.No trauma/complications during surgery for patient." rep provided an x-ray, explant pictures, and intra-op photos of black tissue both inside and removed from patient.The stem, head, and poly insert were revised.
Additional Manufacturer Narrative
Reported event:  an event regarding fretting involving accolade stem was reported.The event was confirmed based on medical review.Method & results:  device evaluation and results:visual inspection: the device was not returned however photographs were provided for review.Fractured femoral stem at head neck junction of trunnion can be seen on the surface of the explanted stem.Material analysis, 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: no clinical or pmh, no operative reports or date of primary tha, no dated serial x-rays, no surgical pathology report, no examination of explanted components.Based upon the information available for review, confirmation of the event description can be made by the x-ray provided, but insufficient data is available to create a medical report for this case.Device history review: could not be performed as lot code information was not provided.  complaint history review: could not be performed as lot code information was not provided.  conclusion:  it was reported that patient had fretting.The event was confirmed based on medical review.A review of the provided medical records by a clinical consultant stated the following comment: no clinical or pmh, no operative reports or date of primary tha, no dated serial x-rays, no surgical pathology report, no examination of explanted components.Based upon the information available for review, confirmation of the event description can be made by the x-ray provided, but insufficient data is available to create a medical report for this case.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
As reported: "revision of left hip due to fractured femoral stem at head neck junction of trunnion.No trauma/complications during surgery for patient." rep provided an x-ray, explant pictures, and intra-op photos of black tissue both inside and removed from patient.The stem, head, and poly insert were revised.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #5
• 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: 10992510
• Report Number: 0002249697-2020-02648
• Device Sequence Number: 10919935
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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 Model Number: 6021-0537
• Device Catalogue Number: 6021-0537
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/12/2021
• 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 Age: 55 YR
• Patient Weight: 146