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-309
Medical Device Problem Codes	Degraded (1153); Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	07/22/2021
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
As reported: "pain and instability.All available information submitted." the patient's right knee was revised.A 3x9 cr insert, size 4 cr femoral component, and size 3 tritanium baseplate were revised to a ts femoral component, ps insert, and new baseplate.
Event or Problem Description
As reported: "pain and instability.All available information submitted." the patient's right knee was revised.A 3x9 cr insert, size 4 cr femoral compoent, and size 3 tritanium baseplate were revised to a ts femoral component, ps insert, and new baseplate.
Additional Manufacturer Narrative
Reported event: an event regarding instability and wear involving a triathlon insert was reported.The event was only confirmed for wear based on photographs.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted triathlon insert with blood spots and wear on insert.Dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: materials reviewed: (b)(6) 2021: stryker pi report.Undated: photo of x-ray ap knee unlabeled.Femur not articulating with tibia, off the anterior medial side, some medial tibial varus and cystic like change at plateau.(b)(6) 2021: vital signs.Stable.(b)(6) 2017: or record.Primary tka cr femur uncemented triathlon, size 3 tibia tritanium, 3x9 mm bearing, 32 asymmetric patella cemented.Bone cement simplex for patella.(b)(6) 2017: operative note.Primary tka.Bmi 42.Oa.No foley or tourniquet.Deficient bone on medial plateau.Confirmation: the event a revision tka cannot be confirmed without additional medical records.The undated/unlabeled x-ray provided did show failure of an uncemented triathlon tka.Root cause: a root cause cannot be ascertained without additional history and medical records.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 photographs.The reported device was not returned however photographs were provided for review.The photographs show a recently explanted triathlon insert with blood spots and wear on insert.Refer attached pictures.The event of instability was not confirmed nor the exact cause be determined because insufficient information was provided.Additional information including return of device are needed to fully investigate the event.If further information becomes available or product is returned , this investigation will be re-opened.

• 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
• MDR Report Key: 12323559
• Report Number: 0002249697-2021-01388
• Device Sequence Number: 17186769
• Product Code: MBH
• UDI-Device Identifier: 07613327050431
• UDI-Public: 07613327050431
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 01/31/2022
• Device Model Number: 5530-G-309
• Device Catalogue Number: 5530-G-309
• Device Lot Number: PT7K9Y
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR