MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; POSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-600
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	03/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that all devices in the lot were manufactured and accepted into final stock with no reported discrepancies.Lot id.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 not returned.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "loose implants right total knee arthroplasty".
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon baseplate 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 provided medical records with clinician indicated."confirmation of event: i can confirm that the patient underwent a primary right cemented triathlon total knee arthroplasty since i was able to review x-rays with the implant in place.I can also confirm that the patient had a revision of that implant with a triathlon ts implant since i was able to review x-rays with the implant in place.I cannot confirm that the revision of the ts implant took place on (b)(6) 2016 since i have no documentation such as office visits, operation reports or post revision x-rays.The last x-ray i was able to see was dated (b)(6) 2015.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of loosening of a cemented triathlon total knee arthroplasty approximately one year following implantation are multifactorial including surgical technique especially in the way the implants are positioned and aligned, cement technique, proper restoration of knee kinematics, as well as patient factors including lifestyle, activity level and bmi.I would not assign any causality to the implant itself.As for the revision root cause, the root causes of loosening of a revision implant that is cemented, approximately three years after implantation are the same as above.The possibility of infection".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 provided medical records with clinician indicated "confirmation of event: i can confirm that the patient underwent a primary right cemented triathlon total knee arthroplasty since i was able to review x-rays with the implant in place.I can also confirm that the patient had a revision of that implant with a triathlon ts implant since i was able to review x-rays with the implant in place.I cannot confirm that the revision of the ts implant took place on (b)(6) 2016 since i have no documentation such as office visits, operation reports or post revision x-rays.The last x-ray i was able to see was dated (b)(6) 2015.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of loosening of a cemented triathlon total knee arthroplasty approximately one year following implantation are multifactorial including surgical technique especially in the way the implants are positioned and aligned, cement technique, proper restoration of knee kinematics, as well as patient factors including lifestyle, activity level and bmi.I would not assign any causality to the implant itself.As for the revision root cause, the root causes of loosening of a revision implant that is cemented, approximately three years after implantation are the same as above.The possibility of infection" 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
It was reported through the communication of an attorney that allegedly the patient was revised due to "loose implants right total knee arthroplasty".

• Brand Name: TRI TS BASEPLATE SIZE 6
• Common Device Name: POSTHESIS, 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 8424763
• Report Number: 0002249697-2019-01357
• Device Sequence Number: 16726164
• Product Code: MBH
• UDI-Device Identifier: 07613327026337
• UDI-Public: 07613327026337
• 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: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 04/30/2018
• Device Catalogue Number: 5521-B-600
• Device Lot Number: HRIV
• 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: 02/15/2019
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2013
• 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: 64 YR
• Patient Sex: Male