MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post-op of a right mako tka, patient fell and sustained a femoral fracture.An im nail was implanted, nothing was removed.Rep confirmed that no further information will be released by the hospital or surgeon.
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.H3 other text : device not returned.
Event or Problem Description
It was reported that post-op of a right mako tka, patient fell and sustained a femoral fracture.An im nail was implanted, nothing was removed.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a triathlon femoral component was reported.Periprosthetic fracture was confirmed via clinician review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical information by a clinical consultant indicated: "a total knee arthroplasty was performed (b)(6) 2023 reportedly with the robot.Operative notes and relevant clinical history and postop care were not provided for review.Apparently postoperative periprosthetic fracture occurred by report on day 1.The fracture was widely displaced and very comminuted.The patient underwent retrograde nailing of the femur.The postoperative course and clinical outcome were not provided for review.Confirmation: a peri-prosthetic femoral fracture around a triathlon component can be confirmed.The timing or events that led to the fracture cannot be confirmed.Use of the mako device for implantation cannot be confirmed.Root cause: a root cause for the fracture cannot be confirmed without additional medical information as well as postoperative x-rays prior to the fracture.At the level of the fracture concern would exist for fracture through the pin tracks created for the mako trackers (this cannot be confirmed)." -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 suffered a periprosthetic fracture aster a fall.A review of the provided medical information by a clinical consultant indicated: "a total knee arthroplasty was performed (b)(6) 2023 reportedly with the robot.Operative notes and relevant clinical history and postop care were not provided for review.Apparently postoperative periprosthetic fracture occurred by report on day 1.The fracture was widely displaced and very comminuted.The patient underwent retrograde nailing of the femur.The postoperative course and clinical outcome were not provided for review.Confirmation: a peri-prosthetic femoral fracture around a triathlon component can be confirmed.The timing or events that led to the fracture cannot be confirmed.Use of the mako device for implantation cannot be confirmed.Root cause: a root cause for the fracture cannot be confirmed without additional medical information as well as postoperative x-rays prior to the fracture.At the level of the fracture concern would exist for fracture through the pin tracks created for the mako trackers (this cannot be confirmed)." the root cause cannot be determined from the limited documentation provided.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.

• Brand Name: TRIATHLON CR FEM COMP #3 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17494207
• Report Number: 0002249697-2023-00882
• Device Sequence Number: 15424147
• Product Code: MBH
• UDI-Device Identifier: 07613327040265
• UDI-Public: 07613327040265
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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 Catalogue Number: 5510F302
• Device Lot Number: 2L7SU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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: Female