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-416
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/17/2017
Type of Reportable Event	Serious Injury
Additional 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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device evaluated by manufacturer? not returned.
Event or Problem Description
This pi is for the left knee.It was reported through the communication of an attorney that allegedly the patient was revised due to "unstable left total knee arthroplasty, all components.".
Event or Problem Description
This pi is for the left knee.It was reported through the communication of an attorney that allegedly the patient was revised due to "unstable left total knee arthroplasty, all components." update 14 october 2019: as per medical review dated 13 august 2019 "component malposition of triathlon ps knee components with a ¿significantly elevated joint line¿ has contributed to gross instability of the arthroplasty requiring exchange of all knee devices after 5-years".
Additional Manufacturer Narrative
An event regarding instability involving a triathlon insert was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: not performed as product was not returned/ remains implanted.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: component malposition of triathlon ps knee components with a ¿significantly elevated joint line¿ has contributed to gross instability of the arthroplasty requiring exchange of all knee devices after 5- years.-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: a review of the provided medical records and x-rays by a clinical consultant indicated: component malposition of triathlon ps knee components with a ¿significantly elevated joint line¿ has contributed to gross instability of the arthroplasty requiring exchange of all knee devices after 5-years.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: 8753785
• Report Number: 0002249697-2019-02506
• Device Sequence Number: 19432599
• Product Code: MBH
• UDI-Device Identifier: 07613327050738
• UDI-Public: 07613327050738
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 5532-G-416
• Device Lot Number: MKR9KY
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR