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

Model Number	5510-F-802
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised due to the medial femoral condyle of the femoral component breaking off.Intra-operatively, insert wear and sharp edges were noted.The femoral component and insert were revised.Rep confirmed that other than pictures and possibly implant information, no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed.Method & results: product evaluation and results: visual: visual inspection of the provided photos indicate an implanted femoral component and insert.The condyle of the femoral component is fractured.Insert wear cannot be confirmed as the device was not returned.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated " both the lateral view x-ray and intra-operative photograph demonstrate a fractured medial femoral condyle of a tka femoral component.Fracture of the medial femoral condyle of a tka femoral component is confirmed.The root cause of this fracture cannot be identified from this limited documentation" -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.Visual inspection of the provided photos indicate an implanted femoral component and insert.The condyle of the femoral component is fractured.A review of medical records with a clinical consultant indicated " both the lateral view x-ray and intra-operative photograph demonstrate a fractured medial femoral condyle of a tka femoral component.Fracture of the medial femoral condyle of a tka femoral component is confirmed.The root cause of this fracture cannot be identified from this limited documentation".No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right knee was revised due to the medial femoral condyle of the femoral component breaking off.Intra-operatively, insert wear and sharp edges were noted.The femoral component and insert were revised.Rep confirmed that other than pictures and possibly implant information, no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed.Method & results: product evaluation and results: visual: visual inspection of the provided photos indicate an implanted femoral component and insert.The condyle of the femoral component is fractured.Insert wear cannot be confirmed as the device was not returned.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated " both the lateral view x-ray and intra-operative photograph demonstrate a fractured medial femoral condyle of a tka femoral component.Fracture of the medial femoral condyle of a tka femoral component is confirmed.The root cause of this fracture cannot be identified from this limited documentation." 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.Visual inspection of the provided photos indicate an implanted femoral component and insert.The condyle of the femoral component is fractured.A review of medical records with a clinical consultant indicated " both the lateral view x-ray and intra-operative photograph demonstrate a fractured medial femoral condyle of a tka femoral component.Fracture of the medial femoral condyle of a tka femoral component is confirmed.The root cause of this fracture cannot be identified from this limited documentation".No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16682518
• Report Number: 0002249697-2023-00359
• Device Sequence Number: 20656259
• Product Code: MBH
• UDI-Device Identifier: 07613327040364
• UDI-Public: 07613327040364
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: 03/31/2016
• Device Model Number: 5510-F-802
• Device Catalogue Number: 5510F802
• Device Lot Number: S3FKM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2011
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male