MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #5L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F501
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: device name#unknown_triathlon component ; cat#unknown ; lot#unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported via medwatch mw5149272 and mw5149273 (reports are the same with a different implant for each report): i had total knee implant on my left leg.I have been having problem with it since day one.Now the bone scan indicates that the implant is showing that it is loose and my doctor is recommending replace the total knee implant.My implant catalog number is the same as in this recall letter; class 2 device recall triathlon tritanium tibial component, see related information date initiated by firm march 30, 2022.Date posted june 3, 2022, recall status1 open3, classified recall number z-1237-2022; recall event id 90241 510(k) number k123486.I have my operative reports from the hospital, and my doctor was indicate that this implant was installed.I have been scheduled for a revision surgery for 2023.Note: catalog numbers provided in the recall notice were not reported in either medwatch report.

• Brand Name: TRIATHLON P/A CR BEADED #5L
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18603253
• Report Number: 0002249697-2024-00156
• Device Sequence Number: 9127934
• Product Code: MBH
• UDI-Device Identifier: 07613327040982
• UDI-Public: 07613327040982
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2024

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 Catalogue Number: 5517F501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/29/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown