MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532-G-611
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised due to unstable knee, poly was compromised when knee opened and poly was replaced successfully.Poly needed to be swapped out due to wear.Additional info.08-aug-2024: ¿ could you please provide details as to what is meant by ¿poly was compromised¿? - patient was revised due to femur moving anterior on tibia in flexion, when opened up saw that the poly post was broken and thus allowing femur to move forward, old poly was removed and same thickness poly was inserted successfully.We do not know what allowed the post to dissociate like that.¿ left or right side: left side.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event: an event regarding instability, wear & fracture involving a triathlon insert was reported.The events for wear and fracture were confirmed via review of the returned device.Method & results: -product evaluation and results: visual inspection of the returned device indicated that the device is fractured and the locking mechanism disassociated.Consistent with disassembly through explantation.Wear is also noted.-clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had primary triathlon total knee arthroplasty since i was able to review an ap x-ray with the implant in place.I cannot confirm the revision or explantation since i have no documentation such as operation note, office notes or post revision x-ray.The explanation given for the femur moving anterior on the tibia in flexion is curious.They attribute that instability due to fracture of the stabilizing ps post.However, the ps post does not restrict anterior movement, only posteriorly directed forces.The root cause of this event cannot be determined with certainty.The root causes of instability are multifactorial including surgical technique, ligament balancing, restoration of knee kinematics, and implant positioning as well as patient lifestyle, activity level and bmi.This patient's bmi was extremely elevated at over 42.The root causes of post fracture are also multifactorial including surgical technique including ligament balancing and restoration of kinematics of the knee as well as implant positioning, as well as patient lifestyle, activity level and bmi, as well as implant factors.As noted above the patient's bmi is extremely elevated at over 42 which definitely could contribute to post breakage." -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 was revised due to instability and insert wear.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had primary triathlon total knee arthroplasty since i was able to review an ap x-ray with the implant in place.I cannot confirm the revision or explantation since i have no documentation such as operation note, office notes or post revision x-ray.The explanation given for the femur moving anterior on the tibia in flexion is curious.They attribute that instability due to fracture of the stabilizing ps post.However, the ps post does not restrict anterior movement, only posteriorly directed forces.The root cause of this event cannot be determined with certainty.The root causes of instability are multifactorial including surgical technique, ligament balancing, restoration of knee kinematics, and implant positioning as well as patient lifestyle, activity level and bmi.This patient's bmi was extremely elevated at over 42.The root causes of post fracture are also multifactorial including surgical technique including ligament balancing and restoration of kinematics of the knee as well as implant positioning, as well as patient lifestyle, activity level and bmi, as well as implant factors.As noted above the patient's bmi is extremely elevated at over 42 which definitely could contribute to post breakage." visual inspection of the returned device indicated that the device is fractured and the locking mechanism disassociated.Consistent with disassembly through explantation.Wear is also noted.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.
Event or Problem Description
Patient was revised due to unstable knee; poly was compromised when knee opened and poly was replaced successfully.Poly needed to be swapped out due to wear.Additional info.08-aug-2024: ¿ could you please provide details as to what is meant by ¿poly was compromised¿? - patient was revised due to femur moving anterior on tibia in flexion, when opened up saw that the poly post was broken and thus allowing femur to move forward, old poly was removed and same thickness poly was inserted successfully.We do not know what allowed the post to dissociate like that.¿ left or right side: left side.

• Brand Name: TRIATHLON PS 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: anna ryan ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20039066
• Report Number: 0002249697-2024-01156
• Device Sequence Number: 6537143
• Product Code: MBH
• UDI-Device Identifier: 07613327050851
• UDI-Public: 07613327050851
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2024

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: 08/31/2022
• Device Catalogue Number: 5532-G-611
• Device Lot Number: A877A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2016
• 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: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 130 KG