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 Codes	Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408); Malposition of Device (2616)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	02/26/2020
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.
Event or Problem Description
It was reported that the patient's right knee was revised due to subsidence of the tibial baseplate due to the baseplate being too small for the patient's anatomy.There are no allegations against the baseplate's manufactured dimensions.A cr knee construct was revised to a ps cemented femur, universal baseplate with stem, a new insert, and cone.Rep confirmed there are no allegations against the revised femur or insert.Rep can provide some photos and reported that no further information will be available.
Event or Problem Description
It was reported that the patient's right knee was revised due to subsidence of the tibial baseplate due to the baseplate being too small for the patient's anatomy.There are no allegations against the baseplate's manufactured dimensions.A cr knee construct was revised to a ps cemented femur, universal baseplate with stem, a new insert, and cone.Rep confirmed there are no allegations against the revised femur or insert.Rep can provide some photos and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding subsidence and incorrect selection involving a tritanium baseplate was reported.The medical review comment confirmed subsidence and loosening.The event of incorrect selection was not confirmed.Method & results -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: - x-ray confirms tibia subsided and loosening, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: - x-ray confirms tibia subsided and loosening.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are required to complete the investigation and determine a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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: 9881074
• Report Number: 0002249697-2020-00601
• Device Sequence Number: 16260738
• Product Code: MBH
• UDI-Device Identifier: 07613327041507
• UDI-Public: 07613327041507
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 05/01/2020

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: 08/31/2024
• Device Model Number: 5536-B-500
• Device Catalogue Number: 5536B500
• Device Lot Number: CTD35625
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 05/01/2020
• 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: 78 YR