MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-413
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/05/2016
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 has been one 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 returned.
Event or Problem Description
Postoperative diagnosis: patient had an index surgery outside the ri, prior to cors.In (b)(6) 2014 doctor revised the patient's right knee for stiffness, changed only the poly.Now he is revising again the patient's right knee for stiffness (disfunction, arthrofibrosis) changing only the poly.
Additional Manufacturer Narrative
This report is being cancelled as a duplicate of the mfr report 0002249697-2016-02177.Any follow up reports will be submitted under the mfr report 0002249697-2016-02177.
Event or Problem Description
Postoperative diagnosis: patient had an index surgery outside the ri, prior to cors.In (b)(6) 2014 doctor revised the patient's right knee for stiffness, changed only the poly.Now he is revising again the patient's right knee for stiffness (disfunction, arthrofibrosis) changing only the poly.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
• 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: 9648915
• Report Number: 0002249697-2020-00193
• Device Sequence Number: 3414151
• Product Code: MBH
• UDI-Device Identifier: 07613327027242
• UDI-Public: 07613327027242
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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 Model Number: 5537-G-413
• Device Catalogue Number: 5537-G-413
• Device Lot Number: MNJKWK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/12/2020
• 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: 44 YR
• Patient Weight: 80