MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5510-F-501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.Device not returned.
Event or Problem Description
As reported: "we noticed the femur primary (medial) condyle was broken.Dr.Then explanted the primary components and replaced with stryker triathlon ts revision knee." spoke to rep.The patient's left knee was converted from a cs to a ts construct.All components were revised.Due to the broken implant, the liner was damaged in situ.The patellar component and baseplate were revised in order to convert the knee, there are no allegations against those implants.
Event or Problem Description
As reported: "we noticed the femur primary (medial) condyle was broken.Dr.Then explanted the primary components and replaced with stryker triathlon ts revision knee." spoke to rep.The patient's left knee was converted from a cs to a ts construct.All components were revised.Due to the broken implant, the liner was damaged in situ.The patellar component and baseplate were revised in order to convert the knee, there are no allegations against those implants.
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed via provided photos.Method & results -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: the photos show that the femoral component medial condyle fractured.The reported event was confirmed.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate the 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's knee was revised due to broken medial condyle whereby the cs construct was converted to a ts construct.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary 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.

• Brand Name: TRIATHLON CR FEM COMP #5 L-CEM
• 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: anna ryan ; raheen business park; centennial park, elstree; limerick WD6 3-SJ ; EI WD6 3SJ ; 61498200
• MDR Report Key: 13266129
• Report Number: 0002249697-2022-00097
• Device Sequence Number: 19999325
• Product Code: MBH
• UDI-Device Identifier: 07613327040296
• UDI-Public: 07613327040296
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 5510-F-501
• Device Catalogue Number: 5510F501
• Device Lot Number: EBY7L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 88 KG