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

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2022

Event Type  Injury  

Event Description

The following was reported: knee revision.

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.

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 Description

The following was reported: knee revision.

• Brand Name: X3 TRIATHLON CS INS SIZE 4 9MM
• Type of Device: 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
• MDR Text Key: 291283745
• Report Number: 0002249697-2022-00667
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045802
• UDI-Public: 07613327045802
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 115 KG