MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	5510-F-501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	05/04/2020
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left knee was revised due to pain.The original surgical plan was to perform a poly exchange.Intra-operatively, the medial condyle of the femoral component was found to have broken off of the implant.The poly, which had metal embedded into it, was also found to have had some wear medially.Patient was revised to a ps femoral component with a ts insert.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed on the basis for inspection of received device.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), which noted that the triathlon cr femoral knee was returned fractured at the medial condyle.The returned device was evaluated with the use of a stereomicroscope at magnifications up to 50x.Bone cement was observed on the proximal portion of the device.The bone cement observed on the medial condyle extended past the edges of the condyles.Damage was observed on the articulating surface of the femoral component consistent with articulation against a hard object/particulate.Macroscopic surface features indicate that the fracture propagated distally with final fracture occurring in overload.The fracture condyle was examined further using a scanning electron microscope (sem).A material analysis was performed which concluded that the fracture morphology of the femoral component is consistent with a fatigue fracture propagating distally with final fracture occurring in overload.Eds showed that the femoral component was consistent with the drawing (astm f75 alloy).Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces.Dimensional and functional analysis could not be performed as the device was returned in fractured condition.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's left knee was revised due to pain.Intra-operatively, the medial condyle of the femoral component was found to have broken off of the implant.Material analysis performed on the returned device concluded that the fracture morphology of the femoral component is consistent with a fatigue fracture propagating distally with final fracture occurring in overload.Eds showed that the femoral component was consistent with the drawing (astm f75 alloy).Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces.The exact cause of the event could not be determined because insufficient information was available with stryker.Further information such as 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 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 pain.The original surgical plan was to perform a poly exchange.Intra-operatively, the medial condyle of the femoral component was found to have broken off of the implant.The poly, which had metal embedded into it, was also found to have had some wear medially.Patient was revised to a ps femoral component with a ts insert.

• Brand Name: TRIATHLON CR FEM COMP #5 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: 10101239
• Report Number: 0002249697-2020-00987
• Device Sequence Number: 3082473
• Product Code: JWH
• UDI-Device Identifier: 07613327040296
• UDI-Public: 07613327040296
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/07/2020

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: 09/30/2018
• Device Model Number: 5510-F-501
• Device Catalogue Number: 5510F501
• Device Lot Number: EELAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 09/07/2020
• 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: 75 YR
• Patient Weight: 104