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
Medical Device Problem Codes	Detachment Of Device Component (1104); Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It has been reported by the customer that the wire surrounding the polyethylene is loose.
Event or Problem Description
It has been reported by the customer that the wire surrounding the polyethylene is loose.
Additional 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
• Common Device Name: 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
• Report Number: 0002249697-2018-00292
• Device Sequence Number: 980073
• Product Code: MBH
• UDI-Device Identifier: 07613327046274
• UDI-Public: 07613327046274
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other