MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G513
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for left knee.Patient would like to know if implants are subject to a recall.Patient reported pain, weakness and instability.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon insert 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 the provided medical records by a clinical consultant indicated: i can confirm that the patient had bilateral total knee arthroplasty since i was able to view radiographs and ct scan images with bilateral total knee arthroplasty in place.The root cause of this event cannot be determined with certainty.Patient subjective complaints of pain, weakness, and instability are not unusual 12 years following index procedures.No useful information regarding patients symptoms and physical examinations i provided.The causes of pain weakness and instability are multifactorial including loosening, infection, development of objective instability as well as polyethylene wear.However no evidence is given for any of these possible etiologies.The patient is reportedly obese and this can contribute to the development of all of the above.Patient lifestyle, activity level and bmi contribute.At this point, with the information supplied, i would not assign any causality to the implant itself.I don't believe these products have been part of a recall but stryker would have to research that.-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: it was reported that the patient is experiencing pain, weakness, and instability post-implantation.The patient would like to know if their implants were part of a recall there were no recalls associated with these parts/lots.The exact cause of the event could not be determined because insufficient information was provided.A review of the provided medical records by a clinical consultant indicated: i can confirm that the patient had bilateral total knee arthroplasty since i was able to view radiographs and ct scan images with bilateral total knee arthroplasty in place.The root cause of this event cannot be determined with certainty.Patient subjective complaints of pain, weakness, and instability are not unusual 12 years following index procedures.No useful information regarding patients symptoms and physical examinations i provided.The causes of pain weakness and instability are multifactorial including loosening, infection, development of objective instability as well as polyethylene wear.However no evidence is given for any of these possible etiologies.The patient is reportedly obese and this can contribute to the development of all of the above.Patient lifestyle, activity level and bmi contribute.At this point, with the information supplied, i would not assign any causality to the implant itself.I don't believe these products have been part of a recall but stryker would have to research that.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: device name#triathlon mb patella pa a35 ; cat#5554l350 ; lot#s6m4h device name#triathlon p/a cr beaded #5l ; cat#5517f501 ; lot#s6eet device name#triathlon prim bead pa sze5 bp ; cat#5526b500 ; lot#s8f3y it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: X3 TRIATHLON CS INSERT #5 13MM
• 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: 19967848
• Report Number: 0002249697-2024-01116
• Device Sequence Number: 15649539
• Product Code: MBH
• UDI-Device Identifier: 07613327045888
• UDI-Public: 07613327045888
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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: 09/30/2016
• Device Catalogue Number: 5531G513
• Device Lot Number: LCO935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2011
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Male