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-E

Device Problems Device Difficult to Setup or Prepare (1487); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2021

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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

A ps poly #4 9mm was used but found to have a substandard locking mechanism.The surgeon decided to not use it after failing to seat in on the tibia and another one had to be ordered in.The surgeon couldn't get the poly seated correctly on the baseplate.A different poly was used to complete the procedure.

Event Description

A ps poly #4 9mm was used but found to have a substandard locking mechanism.The surgeon decided to not use it after failing to seat in on the tibia and another one had to be ordered in.The surgeon couldn't get the poly seated correctly on the baseplate.A different poly was used to complete the procedure.

Manufacturer Narrative

Reported event: an event regarding seating/locking issues involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: device had notable damage consistent with attempted implantation.No other remarkable observations were noted.Material analysis of the returned device noted, 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.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there has been no other similar events for the lot referenced.Conclusions: material analysis of the returned device noted the following: 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.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.

• 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: 11607095
• MDR Text Key: 243530156
• Report Number: 0002249697-2021-00597
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327338355
• UDI-Public: 07613327338355
• Combination Product (y/n): N
• PMA/PMN Number: K172634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5532-G-409-E
• Device Catalogue Number: 5532-G-409-E
• Device Lot Number: 4E02AY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 78