MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5536B500
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/23/2023
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.H3 other text: device not available.
Event or Problem Description
Patient would like to know if knee implants are subject to a recall.Patient noted loosening.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of medical records with a clinical consultant indicated according to the product inquiry a patient who underwent a right total knee arthroplasty complained of "loosening" and wanted to know if the implants were subject to recall.The patient also underwent an aspiration.I can confirm that the patient underwent the right total knee arthroplasty since i was able to review the operation report.I have no other information about the aspiration and i cannot confirm this.Based upon the assumption that the implant could be "loose" the root cause of this event cannot be determined with certainty.Nor can loosening be determined with certainty without any workup including bone scans, ct scan, serial radiographs.The root cause of loosening of what would appear to be a cementless implant (the surgeon made no indication whether these implants were cemented or not) are multifactorial including surgical technique, alignment, position, and restoration of kinematics, bone preparation and proper implantation, if cemented, then cement technique, patient factors including activity level and bmi.With the information given i would not assign any causality to the implant itself." -product history review: review of the device history records indicate 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 lot referenced.Conclusions: a review of medical records with a clinical consultant indicated according to the product inquiry a patient who underwent a right total knee arthroplasty complained of "loosening" and wanted to know if the implants were subject to recall.The patient also underwent an aspiration.I can confirm that the patient underwent the right total knee arthroplasty since i was able to review the operation report.I have no other information about the aspiration and i cannot confirm this.Based upon the assumption that the implant could be "loose" the root cause of this event cannot be determined with certainty.Nor can loosening be determined with certainty without any workup including bone scans, ct scan, serial radiographs.The root cause of loosening of what would appear to be a cementless implant (the surgeon made no indication whether these implants were cemented or not) are multifactorial including surgical technique, alignment, position, and restoration of kinematics, bone preparation and proper implantation, if cemented, then cement technique, patient factors including activity level and bmi.With the information given i would not assign any causality to the implant itself."the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.The patient would like to know if his implants were part of a recall.A review indicated no recalls were associated with the implants.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient would like to know if knee implants are subject to a recall.Patient noted loosening.(b)(6) 2023: update per conversation with patient: patient reported an aspiration.

• Brand Name: TRITANIUM BPLATE TRIATHLON S5
• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18189280
• Report Number: 0002249697-2023-01441
• Device Sequence Number: 7264701
• Product Code: MBH
• UDI-Device Identifier: 07613327041507
• UDI-Public: 07613327041507
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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: 03/31/2026
• Device Catalogue Number: 5536B500
• Device Lot Number: CTD58106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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; Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 107 KG