MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5531-G-409-E

Device Problem Insufficient Information (3190)

Patient Problem Ambulation Difficulties (2544)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

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 catalog numbers and lot codes of other devices listed in this report: 5517f301 triathlon p/a cr beaded #3l lot unknown, 5536b400 tritanium bplate triathlon s4 lot unknown, 5552-l-299 tritanium patella-asymmetric lot unknown, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Left knee manipulation on (b)(6) 2022.

• Brand Name: X3 TRIATHLON CS INSERT #4 9MM
• Type of Device: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15832898
• MDR Text Key: 303994592
• Report Number: 0002249697-2022-01689
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327337150
• UDI-Public: 07613327337150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5531-G-409-E
• Device Catalogue Number: 5531-G-409-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female