MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 14X150MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5566-S-014
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device not returned.
Event or Problem Description
It was reported that the patient's right knee was revised due to instability.Surgeon's original plan was to revise the poly insert, but intra-operatively decided to revise the femoral component as well.A size 4 ts femoral component with stem and augments, and a size 4 ts insert were revised to a size 4 ts femoral component with a stem, cones, and augments, and a 4x19 ts insert.Rep provided explant pictures and revision usage sheet, and confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's right knee was revised due to instability.Surgeon's original plan was to revise the poly insert, but intra-operatively decided to revise the femoral component as well.A size 4 ts femoral component with stem and augments, and a size 4 ts insert were revised to a size 4 ts femoral component with a stem, cones, and augments, and a 4x19 ts insert.Rep provided explant pictures and revision usage sheet, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding, instability involving triathlon stem was reported.The event was not confirmed.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted triathlon stem in used condition with biological material throughout.No other remarkable observations were noted.Clinician review: no medical records were received for review with a clinical consultant.Device history review: 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.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays 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.

• Brand Name: TRI PRESS-FIT STEM 14X150MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10744784
• Report Number: 0002249697-2020-02263
• Device Sequence Number: 3111935
• Product Code: MBH
• UDI-Device Identifier: 07613327026887
• UDI-Public: 07613327026887
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 02/28/2019
• Device Model Number: 5566-S-014
• Device Catalogue Number: 5566-S-014
• Device Lot Number: M8W37
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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: 81 YR