MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #2L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F201
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed via visual inspection.Method & results: product evaluation and results: visual inspection:the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the devices indicate that the devices have been recently explanted and are covered in blood/tissue.A portion of the triathlon femoral component appears to have been fractured.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 fracture at the triathlon femoral component.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the devices indicate that the devices have been recently explanted and are covered in blood/tissue.A portion of the triathlon femoral component appears to have been fractured.Further information such as return of the devices, 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 left knee was revised due to the femoral component cracking nearly in half (crack runs anterior to posterior).Intra-operatively, the following were noted: the lateral side of the implant showed almost complete fibrous ingrowth (almost no bony ingrowth).The damage to the femoral component caused minor damage to the patellar component (not enough to revise the patellar component).The femoral component and liner were revised (no allegations against the revised liner) to a cemented cr femoral component and cs liner.Rep provided pictures.Rep confirmed no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's left knee was revised due to the femoral component cracking nearly in half (crack runs anterior to posterior).Intra-operatively, the following were noted: the lateral side of the implant showed almost complete fibrous ingrowth (almost no bony ingrowth).The damage to the femoral component caused minor damage to the patellar component (not enough to revise the patellar component).The femoral component and liner were revised (no allegations against the revised liner) to a cemented cr femoral component and cs liner.Rep provided pictures.Rep confirmed no further information will be released by the hospital or surgeon.
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.

• Brand Name: TRIATHLON P/A CR BEADED #2L
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19142432
• Report Number: 0002249697-2024-00619
• Device Sequence Number: 7920715
• Product Code: MBH
• UDI-Device Identifier: 07613327040906
• UDI-Public: 07613327040906
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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: 07/31/2026
• Device Catalogue Number: 5517F201
• Device Lot Number: NJ66N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2021
• 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: Unknown