MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5537-G-611
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information pertaining to the device referenced in this report (including x-rays and medical records) has been requested.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Sales rep reported a right knee revision surgery.
Additional Manufacturer Narrative
Corrected data: the event was confirmed.An event regarding revision involving a triathlon insert was reported.The event was confirmed.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
Sales rep reported a right knee revision surgery.

• Brand Name: NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6640516
• Report Number: 0002249697-2017-01873
• Device Sequence Number: 11008302
• Product Code: MBH
• UDI-Device Identifier: 07613327027396
• UDI-Public: 07613327027396
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2017

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: 07/14/2021
• Device Catalogue Number: 5537-G-611
• Device Lot Number: M08K65
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 08/17/2017
• 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: Other; Required Intervention
• Patient Age: 68 YR