MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-313
Medical Device Problem Codes	Degraded (1153); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	03/15/2023
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.The following devices were also listed in this report: triathlon prim bead pa sze3 bp; cat # 5526b300; lot # ahe6p.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not available.
Event or Problem Description
Knee revision due to instability.Poly wear.
Additional Manufacturer Narrative
Reported event an event regarding instability and wear involving a triathlon insert was reported.The wear event was confirmed through evaluation of the returned device.Instability was not confirmed.Method & results -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.-clinician review: a review of the provided medical records by a clinical consultant indicated: "this patient underwent a primary cementless cruciate retaining total knee arthroplasty and about 7 1/2 years later required revision for global instability and fracture of the tibial polyethylene.I can confirm that the primary and revision procedure took place since i was able to view x-rays.I was also able to review the translation of the primary and revision operation note.The root cause of this event cannot be determined with certainty.Causes of multidirectional instability and fracture of the tibial polyethylene are multifactorial including surgical technique factors, patient activity level including bmi, and implant factors.When a total knee exhibits global instability, this puts abnormal stress on the tibial polyethylene and can contribute to its failure.I would not necessarily assign any causality to the implant itself in the face of global instability." -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.Conclusion: it was reported that the patient was revised due to instability.Visual inspection of the returned insert indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.A review of the provided medical records by a clinical consultant did not confirm instability but did indicate that instability can contribute to poly wear: "causes of multidirectional instability and fracture of the tibial polyethylene are multifactorial including surgical technique factors, patient activity level including bmi, and implant factors.When a total knee exhibits global instability, this puts abnormal stress on the tibial polyethylene and can contribute to its failure.I would not necessarily assign any causality to the implant itself in the face of global instability." 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
Knee revision due to instability.Poly wear.

• Brand Name: X3 TRIATHLON CS INSERT #3 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: 16758735
• Report Number: 0002249697-2023-00392
• Device Sequence Number: 16910156
• Product Code: MBH
• UDI-Device Identifier: 07613327045741
• UDI-Public: 07613327045741
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2023

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: 03/31/2018
• Device Model Number: 5531-G-313
• Device Catalogue Number: 5531G313
• Device Lot Number: LDF179
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 75 KG