MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-509-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon p/a cr beaded #5r; cat# 5517f502 ; lot# unknown.Tritanium bplate triathlon s5; cat# 5536b500 ; lot# unknown.Tritanium patella-asymmetric; cat# 5552-l-320 ; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding rom involving a triathlon insert 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 remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient underwent manipulation under anesthesia post-implantation.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 mua 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.Device not returned.
Event or Problem Description
Patient had a manipulation under anesthesia.

• Brand Name: X3 TRIATHLON CS INSERT #5 9MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16836525
• Report Number: 0002249697-2023-00449
• Device Sequence Number: 12649258
• Product Code: MBH
• UDI-Device Identifier: 07613327336511
• UDI-Public: 07613327336511
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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 Model Number: 5531-G-509-E
• Device Catalogue Number: 5531-G-509-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown