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-509
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Insufficient Information (4580)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon asymmetric x3 patella; cat# 5551-g-320; lot# 0y94; triathlon prim cem fxd bplt #5; cat# 5520b500; lot# stehf; triathlon cr fem comp #4 l-cem; cat# 5510f401; lot# stdlb.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.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 not returned.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "status post left tkr with prosthetic joint implant failure".
Additional Manufacturer Narrative
An event regarding revision surgery involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of medical records indicated "root cause analysis: the cause of this event cannot be determined with certainty with the information provided.The reason stated for revision of the primary implant was due to "status post left tkr with prosthetic joint implant failure.".This is a nebulous and imprecise diagnosis.The term "implant failure" is often used to describe simple failure of a total knee arthroplasty due to myriad causes including infection, instability, loosening, impingement, etc.In most cases this does not relate to actual mechanical failure of the implant such as breakage.Therefore it is impossible to assign any causality to the implant with this imprecise diagnosis." -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 medical records indicated "root cause analysis: the cause of this event cannot be determined with certainty with the information provided.The reason stated for revision of the primary implant was due to "status post left tkr with prosthetic joint implant failure.".This is a nebulous and imprecise diagnosis.The term "implant failure" is often used to describe simple failure of a total knee arthroplasty due to myriad causes including infection, instability, loosening, impingement, etc.In most cases this does not relate to actual mechanical failure of the implant such as breakage.Therefore it is impossible to assign any causality to the implant with this imprecise diagnosis." the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
No new information.

• Brand Name: TRIATHLON CR 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8632953
• Report Number: 0002249697-2019-02060
• Device Sequence Number: 16732739
• Product Code: MBH
• UDI-Device Identifier: 07613327050530
• UDI-Public: 07613327050530
• 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: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: 12/31/2013
• Device Catalogue Number: 5530-G-509
• Device Lot Number: MERL0D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male