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

Catalog Number 5532-G-509

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

On (b)(6) 2018, during the operation of a permanent knee cement prosthesis of the triathlon knee, it was found that there is no possibility of fully snapping the prosthesis # 5 / 9mm.The insert was removed with a no-problem new insert # 5 / 9mm.All operations during the operation were performed in accordance with the triathlon operating technique.

Event Description

On (b)(6) 2018, during the operation of a permanent knee cement prosthesis of the triathlon knee, it was found that there is no possibility of fully snapping the prosthesis # 5 / 9mm.The insert was removed with a no-problem new insert # 5 / 9mm.All operations during the operation were performed in accordance with the triathlon operating technique.

Manufacturer Narrative

An event regarding seating/locking issues involving a triathlon insert was reported.The event was not confirmed.Conclusions: the event could not be confirmed nor the root cause determined.If additional information becomes available, this investigation will be reopened.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7814116
• MDR Text Key: 118241129
• Report Number: 0002249697-2018-02670
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050776
• UDI-Public: 07613327050776
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 5532-G-509
• Device Lot Number: 82518817D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/24/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other