MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5536-B-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
As reported: "patient fractured her [left] proximal tibia.Surgeon revised the baseplate and added a cone.The femur and patella are not involved.X-ray showing fracture, original surgery sheet, and revision surgery sheet were provided.Rep, confirmed there are no allegations against the revised liner and that no further information will be released by hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving triathlon baseplate was reported.The event was confirmed by medical review.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "one single ap x-ray of the left knee was available for review.This x-ray demonstrated a loose tibial component that is displaced and angulated in to a varus position.There is a small fracture of the tibial plateau along the medial periphery thus confirming the tibial fracture.No information was provided to confirm the revision surgery.The root cause of the failure of fixation and fracture can not be determined.Multiple view pre-operative x-rays and early post op x-rays for comparison ,as well as any other studies completed i.E., ct bone scan, and infection labs would be necessary to determine the cause of the loosening and fracture.Post-operative x-rays and an operative report would confirm the revision tka." -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 reported lot.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.
Event or Problem Description
As reported: "patient fractured her [left] proximal tibia.Surgeon revised the baseplate and added a cone.The femur and patella are not involved.X-ray showing fracture, original surgery sheet, and revision surgery sheet were provided.Rep, confirmed there are no allegations against the revised liner and that no further information will be released by hospital or surgeon.

• Brand Name: TRITANIUM BPLATE TRIATHLON S5
• 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: 10982150
• Report Number: 0002249697-2020-02623
• Device Sequence Number: 703071
• Product Code: MBH
• UDI-Device Identifier: 07613327041507
• UDI-Public: 07613327041507
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 03/31/2025
• Device Model Number: 5536-B-500
• Device Catalogue Number: 5536B500
• Device Lot Number: CTD43706
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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: 63 YR