MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-411
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/30/2020
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.As reported by rep: "revision of x3 ts insert, due to global instability." a 4x11 ts insert was revised to a 4x16 ts insert.Spoke to rep, who confirmed no further information will be released by the hospital or surgeon.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM
• 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: 10288166
• Report Number: 0002249697-2020-01466
• Device Sequence Number: 11394436
• Product Code: MBH
• UDI-Device Identifier: 07613327027228
• UDI-Public: 07613327027228
• 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: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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: 05/31/2023
• Device Model Number: 5537-G-411
• Device Catalogue Number: 5537-G-411
• Device Lot Number: L41EPP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/17/2020
• 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: 67 YR
• Patient Weight: 84