MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TRABECULAR METAL CRUCIATE RETAINING STANDARD POROUS FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - concomitant devices - persona trabecular metal two-peg porous tibial tray right size f catalog #: 42530007502 lot #: 65405331, persona cruciate retaining articular surface right 10mm catalog #: 42522000510 lot #: 65376620.G2 - report source - foreign: event occurred in australia.The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event:.0001822565-2023-03807.

Event Description

It was reported that the patient underwent a right knee arthroplasty revision to address aseptic loosening post-operatively.No additional information is available at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.This complaint has been reported under 0001822565-2023-03807.

Event Description

Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.This complaint has been reported under 0001822565-2023-03807.

• Brand Name: PERSONA TRABECULAR METAL CRUCIATE RETAINING STANDARD POROUS FEMORAL COMPONENT
• 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: 18400215
• MDR Text Key: 331414494
• Report Number: 0001822565-2023-03804
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502806602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male