MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #5 CR INSERT 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530P511

Device Problem Degraded (1153)

Patient Problem Subluxation (4525)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding wear involving a triathlon insert was reported.The event was confirmed via review of the provided photographs.Method & results: -product evaluation and results: visual inspection: the device was not returned; however, photographs were provided for review.The photos show a recently explanted insert with signs of wear.-clinician review: no medical records were received for review with a clinical consultant.-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 insert wear.Visual inspection: the device was not returned; however, photographs were provided for review.The photos show a recently explanted insert with signs of wear.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Did a triathlon tibial insert swap from a 5x11 to a 5x19 of a right knee due to soft tissue stretching, and subluxation of the femur relative to the tibia, which caused posterior poly wear.The only information on the history is that was originally done in 2005, thought to have been done at (b)(6) hospital.

• Brand Name: TRIATHLON #5 CR INSERT 11MM
• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19211349
• MDR Text Key: 341353784
• Report Number: 0002249697-2024-00660
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041835
• UDI-Public: 07613327041835
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2010
• Device Catalogue Number: 5530P511
• Device Lot Number: LN188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2005
• 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: 80 YR
• Patient Sex: Female