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

Catalog Number 5530-G-611

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate 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

Triathlon tka procedure with a size 6 baseplate.A size 6 x 11 insert was placed on the baseplate and an attempt to secure it into the baseplate was made.It appeared to be fully seated, but when the insert was checked if locked, the surgeon was able to lift the insert out of the baseplate.A second 6 x 11 insert was opened and the surgeon was able to secure that one to the baseplate.

Manufacturer Narrative

An event regarding seating/locking issues involving a triathlon insert was reported.The event was not confirmed by product inspection.A material analysis engineer indicated, "damages observed on insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." a device history review confirmed all devices accepted into finished goods conformed to specification.No other events were reported for the lot indicated.The event could not be confirmed nor the root cause could be determined because the device was returned damaged.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

Triathlon tka procedure with a size 6 baseplate.A size 6 x 11 insert was placed on the baseplate and an attempt to secure it into the baseplate was made.It appeared to be fully seated, but when the insert was checked if locked, the surgeon was able to lift the insert out of the baseplate.A second 6 x 11 insert was opened and the surgeon was able to secure that one to the baseplate.

• Brand Name: TRIATHLON CR 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: 7548337
• MDR Text Key: 109364309
• Report Number: 0002249697-2018-01593
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050592
• UDI-Public: 07613327050592
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 5530-G-611
• Device Lot Number: W409ER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 205