MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5550-G-278
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	11/21/2012
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 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 failed right total knee arthroplasty, mechanical loosening of components.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon patella was reported.The event was confirmed.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of medical records with a clinical consultant indicated "confirmation of event: based upon the information provided with the product inquiry, i can confirm that the patient underwent a total knee arthroplasty on (b)(6) 2011 and a revision of that knee on (b)(6) 2012.Corroborating these events are the grids that are provided that contain evidence of product usage and the operation report for the revision surgery.Root cause analysis: the root cause of this event cannot be determined with the information supplied.The root causes of revision total knee arthroplasty for mechanical loosening at about 1 1/2 years following surgery are multifactorial including surgical technique, patient factors including lifestyle, activity level, and bmi.The implant itself should not be assigned any causality if there was no evidence of malfunction or material and mechanical failure of the implant itself." -product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of medical records with a clinical consultant indicated "confirmation of event: based upon the information provided with the product inquiry, i can confirm that the patient underwent a total knee arthroplasty on (b)(6) 2011 and a revision of that knee on (b)(6) 2012.Corroborating these events are the grids that are provided that contain evidence of product usage and the operation report for the revision surgery.Root cause analysis: the root cause of this event cannot be determined with the information supplied.The root causes of revision total knee arthroplasty for mechanical loosening at about 1 1/2 years following surgery are multifactorial including surgical technique, patient factors including lifestyle, activity level, and bmi.The implant itself should not be assigned any causality if there was no evidence of malfunction or material and mechanical failure of the implant itself." 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 SYMMETRIC X3 PATELLA
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• 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: 8879405
• Report Number: 0002249697-2019-02788
• Device Sequence Number: 227466
• Product Code: MBH
• UDI-Device Identifier: 07613327014730
• UDI-Public: 07613327014730
• 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: 2011
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 02/28/2016
• Device Catalogue Number: 5550-G-278
• Device Lot Number: D308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2011
• 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: 56 YR
• Patient Sex: Male