MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Model Number	5510-F-402
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that the patient's right knee was revised due to the medial condyle of the femoral component breaking off.A cr femur and cs insert were revised to a ts femur and new insert.Rep confirmed that there are no allegations against the revised liner.Rep reported he can send an explant picture and also confirmed that no further information will be released.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed by inspection of received image of device.Method & results: device evaluation and results: the device was not returned.Visual inspection of the received image of the device noted one of the condyles of the device fractured.The device is observed to be in 2 parts with biological matter around the posterior surface.Dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.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: it was reported that the patient's right knee was revised due to the medial condyle of the femoral component breaking off.Visual inspection of the received image of the device noted one of the condyles of the device fractured.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened. product surveillance will continue to monitor for trends.
Event or Problem Description
It was reported that the patient's right knee was revised due to the medial condyle of the femoral component breaking off.A cr femur and cs insert were revised to a ts femur and new insert.Rep confirmed that there are no allegations against the revised liner.Rep reported he can send an explant picture and also confirmed that no further information will be released.

• Brand Name: TRIATHLON CR FEM COMP #4 R-CEM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11155278
• Report Number: 0002249697-2021-00099
• Device Sequence Number: 19769367
• Product Code: MBH
• UDI-Device Identifier: 07613327040289
• UDI-Public: 07613327040289
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: 01/31/2016
• Device Model Number: 5510-F-402
• Device Catalogue Number: 5510F402
• Device Lot Number: SY8HX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/01/2021
• 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: 50 YR
• Patient Weight: 123