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-709

Device Problems Detachment Of Device Component (1104); Scratched Material (3020)

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

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported by the customer that the wire surrounding the polyethylene is loose.

Event Description

It has been reported by the customer that the wire surrounding the polyethylene is loose.

Manufacturer Narrative

Corrected data: device evaluated by mfg.An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed by visual inspection.Method & results: device evaluation and results: one insert with lot code lft480 was returned inside the outer blister for evaluation.There are scratches on the anterior of the locking wire groove of the insert.The locking wire is bent and has come out or its groove.There are scratches on the inferior surface of the insert.The marks on the locking wire and scratches on the inferior surface of the insert are consistent with attempted implantation of the device.Medical records received and evaluation: not performed as no medical records were received.Device history review: dhr review for the reported lot was satisfactory.Complaint history review: chr review for the reported lot confirmed that there are no other similar events reported.Conclusions: based on the visual inspection of the returned component, the damage observed on the insert component is consistent with attempted seating of the insert onto the baseplate.It is reported that the event was an out of pack issue however, the visual analysis would indicate that this was not the case.The root cause cannot be confirmed as no photographs were taken during the procedure when the issue was first identified.No further investigation is required 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: 7235446
• MDR Text Key: 98862700
• Report Number: 0002249697-2018-00292
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327046274
• UDI-Public: 07613327046274
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

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: 04/30/2022
• Device Catalogue Number: 5532-G-709
• Device Lot Number: LFT480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 02/12/2018
• Supplement Dates FDA Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other