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

Catalog Number	5536B500
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathalon baseplate was reported.The event was confirmed through visual inspection of the photograph of the explanted device.Method & results: device evaluation and results: visual inspection: the reported device was not returned however a photograph was provided for review.The photograph shows a recently explanted triathalon baseplate with evidence of a fracture.There is also the presence of biological matter.Medical records received and evaluation: 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 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
It was reported that patient's right knee was revised due to a broken tibial baseplate.No trauma or other possible causes/ contributors to implant breakage were reported.When the baseplate was removed, the keel and one of the cruciform pegs remained in the bone and had to be removed separately.Patient was revised to a universal baseplate with a 100mm cemented stem.

• Brand Name: TRITANIUM BPLATE TRIATHLON S5
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8152535
• Report Number: 0002249697-2018-03982
• Device Sequence Number: 19220564
• Product Code: MBH
• UDI-Device Identifier: 07613327041507
• UDI-Public: 07613327041507
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 05/31/2022
• Device Catalogue Number: 5536B500
• Device Lot Number: CTD16851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/11/2018
• 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: 65 YR
• Patient Weight: 143