MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA TRABECULAR METAL TWO-PEG POROUS FXD BRG RT SZ E; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

Additional associated products & mdrs: 42502806402 persona femur trabecular metal cruciate retaining std porous lot# 65741865 mdr: 0001822565-2024-01133.Additional associated products: 42522000510 persona articular surface fixed brg cruciate retaining rt 10 mm lot# 65644386.

Event Description

It was reported a patient underwent a knee revision surgery eleven months post implantation due to metal allergy.No additional information available.

• Brand Name: PERSONA TIBIA TRABECULAR METAL TWO-PEG POROUS FXD BRG RT SZ E
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19031181
• MDR Text Key: 339222653
• Report Number: 0001822565-2024-01134
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024510562
• UDI-Public: (01)00889024510562(17)320929(10)65596938
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007102
• Device Lot Number: 65596938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 90 KG