MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #8 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F802
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Femoral component implanted in 2017 had to be removed because the femoral component was fractured at the transition between the anterior chamber and the distal part.Implantation in 2017 was unremarkable and performed according to standard procedure.Explantation after presumption of loosening of the component, discovery of the broken implant.
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.H3 other text: device not returned to the manufacturer.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed via provided photographs of the device.Method & results: -product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show that the femoral component has fractured at the condyle.The bone-interfacing side of the device appears covered in a layer of bone cement.-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 of the femoral component.The reported device was not returned; however, photographs were provided for review.The photographs show that the femoral component has fractured at the condyle.The bone-interfacing side of the device appears covered in a layer of bone cement.The exact cause of the event could not be determined from the information provided.Additional information such as return of the device, pathology reports, pre- and post-operative x-rays, the primary and revision operation reports, patient history and follow-up notes are needed to further investigate root cause.No further investigation for this event is possible at this time.If device(s) and/or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Correction: d6a.
Event or Problem Description
Femoral component implanted in 2017 had to be removed because the femoral component was fractured at the transition between the anterior chamber and the distal part.Implantation in 2017 was unremarkable and performed according to standard procedure.Explantation after presumption of loosening of the component, discovery of the broken implant.

• Brand Name: TRIATHLON CR FEM COMP #8 R-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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17907271
• Report Number: 0002249697-2023-01174
• Device Sequence Number: 18051204
• Product Code: MBH
• UDI-Device Identifier: 07613327040364
• UDI-Public: 07613327040364
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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: 02/29/2020
• Device Catalogue Number: 5510F802
• Device Lot Number: EMXAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• 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 Sex: Unknown