MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5532-G-413
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding instability.There have been no other similar events for the reported lot.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
The doctor revised a tibial insert from a 4x13 to a 4x16 due to pain/instability.No issues were observed with the insert implant.The original surgery was performed on (b)(6) 2016.Update 06/december/2018: rep provided a primary operative report with implant information, x-rays, and revision implant sheet and reported that no further information is available due to hospital policy.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 8213057
• Report Number: 0002249697-2019-00017
• Device Sequence Number: 16650412
• Product Code: MBH
• UDI-Device Identifier: 07613327050721
• UDI-Public: 07613327050721
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

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: No Information
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 5532-G-413
• Device Lot Number: T433XA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/03/2019
• 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
• Patient Age: 66 YR