MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #8 L-CEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	5510-F-801
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	01/29/2020
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.Device not returned.
Event or Problem Description
It was reported that the patient's left knee was revised due to a fracture of the implanted femoral component.Possible cause or contributor for device fracture was not reported to the rep.The patient's femur did not fracture.As a result of the device fracture, the patient's knee construct became mis-aligned, causing wear of the patellar component and loosening of the tibial baseplate.The patient's entire knee construct was revised.Rep confirmed that there are no allegations against the revised insert.Rep also confirmed that he has some pictures pertaining to the event, and that no further information will be available.
Event or Problem Description
It was reported that the patient's left knee was revised due to a fracture of the implanted femoral component.Possible cause or contributor for device fracture was not reported to the rep.The patient's femur did not fracture.As a result of the device fracture, the patient's knee construct became mis-aligned, causing wear of the patellar component and loosening of the tibial baseplate.The patient's entire knee construct was revised.Rep confirmed that there are no allegations against the revised insert.Rep also confirmed that he has some pictures pertaining to the event, and that no further information will be available.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed based on provided photos.Method & results -product evaluation and results: the reported device was not returned however photographs were provided for review.The photo presented the recently explanted femoral component which was fractured.Refer to attached pictures for details.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms loose femoral component, photo confirms fracture of femoral component, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the femoral component was fractured.Possible cause or contributor for device fracture was not reported to the rep.As a result of the device fracture, the patient's knee construct became mis-aligned, causing wear of the patellar component and loosening of the tibial baseplate.The patient's entire knee construct was revised.The provided photo confirmed that the femoral component was fractured.Clinician review indicated that x-ray confirmed loose femoral component.The exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components 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 #8 L-CEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9757905
• Report Number: 0002249697-2020-00404
• Device Sequence Number: 2288953
• Product Code: JWH
• UDI-Device Identifier: 07613327040340
• UDI-Public: 07613327040340
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 02/28/2014
• Device Model Number: 5510-F-801
• Device Catalogue Number: 5510F801
• Device Lot Number: SLPJH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: 61 YR
• Patient Weight: 138