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

Catalog Number	5530-G-716
Medical Device Problem Codes	Material Erosion (1214); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/30/2023
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.H3 other text : not available.
Event or Problem Description
It was reported that the patient's right knee was revised due to wear and joint laxity.A poly exchange was performed.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding wear and instability involving a triathlon insert was reported.The events were confirmed via provided photographs of the device.Method & results: product evaluation and results: the device was not returned; however, photographs were provided for review.The photographs show a recently explanted insert which is covered in blood.Significant material loss is visible on the anterior portion of both condyles.Clinician review: review of the images of the explanted device by a clinical consultant indicated the following: "the wear pattern would indicate high and pathologic loading of the posterior aspect of the polyethylene.This sort of loading would typically be associated with instability in the ap plane leading to posterior subluxation and thus high stresses in the polyethylene.An underlying preexistent manufacturing or other problem in the polyethylene cannot be determined." 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 wear and joint laxity.The device was not returned; however, photographs were provided for review.The photographs show a recently explanted insert which is covered in blood.Significant material loss is visible on the anterior portion of both condyles.Review of the images of the explanted device by a clinical consultant indicated the following: "the wear pattern would indicate high and pathologic loading of the posterior aspect of the polyethylene.This sort of loading would typically be associated with instability in the ap plane leading to posterior subluxation and thus high stresses in the polyethylene.An underlying preexistent manufacturing or other problem in the polyethylene cannot be determined." further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right knee was revised due to wear and joint laxity.A poly exchange was performed.Rep confirmed that no further information will be released by the hospital or surgeon.

• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18309848
• Report Number: 0002249697-2023-01544
• Device Sequence Number: 6643942
• Product Code: MBH
• UDI-Device Identifier: 07613327045536
• UDI-Public: 07613327045536
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: 10/31/2011
• Device Catalogue Number: 5530-G-716
• Device Lot Number: LAG979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2006
• 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 Sex: Male
• Patient Weight: 126 KG