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

Model Number 5532-G-409

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured, and accepted into final stock with no relevant reported discrepancies.There have been no other similar 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

The following was reported: during a ptg triathlon procedure, the surgeon was unable to place the implant because the metal ring became detached during insertion.

Manufacturer Narrative

Reported event.An event regarding disassociation involving a triathlon insert was reported.The event was confirmed via product evaluation.Method & results.Product evaluation and results: visual inspection: visual inspection of the returned device noted the following: device was returned in used condition.The metal locking wire was observed to be missing confirming the reported disassociation event.There was also damage consistent with attempted implantation.Material analysis: damage observed on the insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: 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 referenced.Conclusions: device was returned in used condition.The metal locking wire was observed to be missing confirming the reported disassociation event.There was also damage consistent with attempted implantation.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The following was reported: during a ptg triathlon procedure, the surgeon was unable to place the implant because the metal ring became detached during insertion.

• 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: 10592499
• MDR Text Key: 208728904
• Report Number: 0002249697-2020-02000
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050707
• UDI-Public: 07613327050707
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5532-G-409
• Device Catalogue Number: 5532-G-409
• Device Lot Number: K70MPK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other