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
Medical Device Problem Codes	Unstable (1667); Positioning Problem (3009)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional 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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
During medical procedure, the surgeon found that tibial insert was very hard to implant.After beat several times, the surgeon felt tibial insert was instability.And then, the surgeon took the tibial insert out to implant again.But, the wire was out of insert and could not be used again.Finally, the other replacement was used to finish procedure.The surgery was delay nearly 1 hour.
Event or Problem Description
During medical procedure, the surgeon found that tibial insert was very hard to implant.After beat several times, the surgeon felt tibial insert was instability.And then, the surgeon took the tibial insert out to implant again.But, the wire was out of insert and could not be used again.Finally, the other replacement was used to finish procedure.The surgery was delay nearly 1 hour.
Additional Manufacturer Narrative
An event regarding seating/locking issue involving traithlon insert was reported.The event was confirmed.Method & results: device evaluation and results: damage observed on the insert consistent with attempted implantation.Clinician review: no medical records were received for review with a clinical consultant.Device 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 reported lot.Conclusion: the investigation concluded that 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 examine.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: 9711542
• Report Number: 0002249697-2020-00305
• Device Sequence Number: 1964517
• Product Code: MBH
• UDI-Device Identifier: 07613327050707
• UDI-Public: 07613327050707
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 04/06/2020

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: 03/31/2024
• Device Model Number: 5532-G-409
• Device Catalogue Number: 5532-G-409
• Device Lot Number: 286D81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 01/19/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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
• Patient Age: 65 YR
• Patient Weight: 78