MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE 4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-409
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: knee revision.
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.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a triathlon insert was reported.The event was only confirmed for wear based on product evaluation.Method & results: -device 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.Dimensional inspection: not performed as the device was returned damaged.Functional inspection: not performed as the device was returned damaged.Material analysis: not performed as there is no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.-clinician review: the available medical records were provided to the consulting clinician for a review which noted," this failure was specifically related to the polyethylene component which had to be replaced at about six years following implantation.I can confirm that the event occurred because i saw both the primary and revision operation report although i did not see a postop x-ray after the revision.It would be helpful to have an analysis of the implant to determine the type of failure of the polyethylene.Surgical technique factors, patient factors and implant factors can contribute to this event.In this case the patient's bmi certainly can contribute.I cannot comment on whether there was instability or a tight flexion gap." -device history review: all 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 reported lot.Conclusion: the event was only confirmed for wear based on product evaluation.The available medical records were provided to the consulting clinician for a review which noted," this failure was specifically related to the polyethylene component which had to be replaced at about six years following implantation.I can confirm that the event occurred because i saw both the primary and revision operation report although i did not see a postop x-ray after the revision.It would be helpful to have an analysis of the implant to determine the type of failure of the polyethylene.Surgical technique factors, patient factors and implant factors can contribute to this event.In this case the patient's bmi certainly can contribute.I cannot comment on whether there was instability or a tight flexion gap." no further investigation is possible at this time.If additional information becomes available, the pi will be reopened.
Event or Problem Description
The following was reported: knee revision.

• Brand Name: X3 TRIATHLON CS INS SIZE 4 9MM
• 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 ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14342957
• Report Number: 0002249697-2022-00667
• Device Sequence Number: 20387970
• Product Code: MBH
• UDI-Device Identifier: 07613327045802
• UDI-Public: 07613327045802
• 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: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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: 12/31/2020
• Device Model Number: 5531-G-409
• Device Catalogue Number: 5531G409
• Device Lot Number: LET620
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2015
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 115 KG