MAUDE Adverse Event Report: ENCORE MEDICAL L.P DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER + ADD

Catalog Number 130-03-735

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2024

Event Type  Injury  

Event Description

Revision surgery - due to resurfaced an unresurfaced patella.

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER + ADD
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18966137
• MDR Text Key: 338431701
• Report Number: 1644408-2024-00344
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912108553
• UDI-Public: 00888912108553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 130-03-735
• Device Lot Number: 156N2270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 74 YR
• Patient Sex: Male