MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 31MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-631
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding a revision due to patient factors involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: not performed as medical records were not provided.Product history review: indicated 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 lot or sterile lot referenced.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.It is noted that the patient is mentally unstable and jumped off a balcony, tearing his retinaculum.The surgeon washed out the wound and revised the ts insert.Further information such as product evaluation, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient's right knee was revised.As reported by rep: "patient is mentally unstable and jumped off a balcony, tearing his retinaculum.Doctor washed wound and swapped out ts liner for a brand new one".Rep also reported there were no allegations against the liner.

• Brand Name: NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 31MM
• 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: 7953936
• Report Number: 0002249697-2018-03260
• Device Sequence Number: 16469188
• Product Code: MBH
• UDI-Device Identifier: 07613327027457
• UDI-Public: 07613327027457
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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: 02/28/2023
• Device Catalogue Number: 5537-G-631
• Device Lot Number: N019PT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/10/2018
• 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: 54 YR
• Patient Weight: 114