MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5537-G-325
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not available.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly on or about (b)(6) 2018, the patient underwent knee replacement surgery which was a substantial factor in causing the injuries which the patient suffers.
Additional Manufacturer Narrative
Additional information: 510k added an event regarding revision involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: visual, dimensional, functional and material analysis not be performed as the device is not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the product history records could not be performed as lot code are unknown.Complaint history review: a complaint history review could not be performed as lot code are unknown.Conclusions: it was reported that patient underwent knee replacement surgery with a defective device which was a substantial factor in causing the injuries which the patient suffers.The event could not be confirmed nor the exact cause of the event could be determined because insufficient information was available.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly on or about (b)(6)2018 the patient underwent knee replacement surgery which was a substantial factor in causing the injuries which the patient suffers.

• Brand Name: NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM
• 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: 8636836
• Report Number: 0002249697-2019-02080
• Device Sequence Number: 1821598
• Product Code: MBH
• UDI-Device Identifier: 07613327027181
• UDI-Public: 07613327027181
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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 Catalogue Number: 5537-G-325
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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