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

Model Number	5530-G-413
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	08/12/2021
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.
Event or Problem Description
The following was reported: knee revision for instability.
Additional Manufacturer Narrative
Reported event: an event regarding instability and wear involving a triathlon insert was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device confirms that the device was worn/damaged at a posterior edge which is consistent with articulation against hard object.Explantation damage was also observed on the insert.Material analysis: no material non-conformances with the uhmwpe insert were found, nor any manufacturing defects seen on any of the device¿s surfaces.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the patient underwent a left cementless cruciate retaining triathlon total knee arthroplasty in 2014.It required revision for instability in 2021.I can confirm that the event occurred since i was able to review xrays and the translation of a brief operation note for the primary and revision surgery.Regarding the possible root cause of this event, revision for late instability is a common problem.I see no intrinsic problem with the implant.Instability is related to the patient¿s activity level and the competency of the ligaments surrounding the knee." -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 of the knee.Visual inspection of the returned device confirms that the device was worn/damaged at a posterior edge which is consistent with articulation against hard object.Explantation damage was also observed on the insert.No material non-conformances with the uhmwpe insert were found, nor any manufacturing defects seen on any of the device¿s surfaces.A review of the provided medical information by a clinical consultant indicated the following: "i can confirm that the event occurred since i was able to review xrays and the translation of a brief operation note for the primary and revision surgery.Regarding the possible root cause of this event, revision for late instability is a common problem.I see no intrinsic problem with the implant.Instability is related to the patient¿s activity level and the competency of the ligaments surrounding the knee." it was reported that the patient was "very active" post-implantation, so this likely contributed to the device failure.This would need to be supported by further patient history information.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following was reported: knee revision for instability.

• Brand Name: TRIATHLON CR 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12441497
• Report Number: 0002249697-2021-01519
• Device Sequence Number: 17057588
• Product Code: MBH
• UDI-Device Identifier: 07613327050509
• UDI-Public: 07613327050509
• 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: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 03/31/2019
• Device Model Number: 5530-G-413
• Device Catalogue Number: 5530-G-413
• Device Lot Number: MNEM31
• 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: 08/16/2021
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2014
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 75 KG