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

Model Number	5517-F-302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding a patient factors of a triathlon femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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: after implantation of a cr press-fit knee, while the patient was still open, decided to look in the joint and removed the implanted insert (reason unknown) and the tourniquet was lifted.Excessive bleeding was noted in the patient.The vascular team was called in, and the rep left the operating room.Measures taken to address the bleeding were not reported beyond the fact that the femoral component was removed.Once addressed, the original femoral component was re-implanted, and a new insert was re-implanted.Surgeon stated that the medial side of the knee felt unstable and decided to convert the knee to a ps knee (no details provided).To accommodate the new insert, the original tibial baseplate was removed, and a universal baseplate was implanted along with the new femoral component and insert required for the conversion.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: device name#x3 triathlon insert cs #4 12mm; cat#5531-g-412-e; lot#6e6v2p.Device name#tritanium bplate triathlon s4; cat#5536b400; lot#ctd97214.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned to the manufacturer.
Event or Problem Description
The following occurred during a right mako knee: after implantation of a cr press-fit knee, while the patient was still open, surgeon wanted to look in the joint and removed the implanted insert (reasons for wanting to inspect the joint were not reported) and the tourniquet was lifted.Excessive bleeding was noted in the patient, the vascular team was called in and the rep left the operating room.Measures taken to address the bleeding were not reported to the rep beyond the fact that the femoral component was removed.Once addressed, the original femoral component was re-implanted and a new insert was re-implanted.Surgeon stated that the medial side of the knee felt unstable and decided to convert the knee to a ps knee (no details why knee was unstable were reported by the surgeon).To accommodate the new insert, the original tibial baseplate was removed and a universal baseplate was implanted along with the new femoral component and insert required for the conversion.Surgery was completed successfully with a delay of approximately 90 minutes.Rep confirmed that no allegations were made against the cuts made by the robot.

• Brand Name: TRIATHLON P/A CR BEADED #3R
• 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: 17160406
• Report Number: 0002249697-2023-00692
• Device Sequence Number: 17581847
• Product Code: MBH
• UDI-Device Identifier: 07613327040951
• UDI-Public: 07613327040951
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051380
• 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
• Report Date (Section B): 06/20/2023

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 Model Number: 5517-F-302
• Device Catalogue Number: 5517F302
• Device Lot Number: DDTEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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 Age: 67 YR
• Patient Sex: Female