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

Model Number 5532-G-313

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Dr.Inserted a triathlon ps tibial insert and noticed part of the locking wire sticking up above the edge of the baseplate.The insert was removed and replaced with another of the same size without further incident.Update 30/april/2019 wg: surgical delay is reported as "yes".Update: "delay was less than a minute.".

Event Description

Dr.Inserted a triathlon ps tibial insert and noticed part of the locking wire sticking up above the edge of the baseplate.The insert was removed and replaced with another of the same size without further incident.Update 30/april/2019 wg: surgical delay is reported as "yes".Update: "delay was less than a minute.".

Manufacturer Narrative

Upon review, h1 was noted incorrect.This report is to correct h1.H3 other text : device not returned.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8637047
• MDR Text Key: 145967182
• Report Number: 0002249697-2019-02081
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050653
• UDI-Public: 07613327050653
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 5532-G-313
• Device Catalogue Number: 5532-G-313
• Device Lot Number: 97898118D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR