MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA TRABECULAR METAL 2-PEG POROUS FXD BRG RT SIZE H; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Malposition of Device (2616)

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Deformity/ Disfigurement (2360); Joint Contracture (4528); Swelling/ Edema (4577)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs; 42522100910 articular surface medial congruent (mc) right 10 mm lot# 64119302 mdr: 3007963827-2024-00031.42502806602 femur trabecular metal cruciate retaining (cr) std porous lot# 64317789 mdr: 0001822565-2024-00497.

Event Description

It was reported a patient reports pain, intermittent swelling, and deformity since surgery and then began experiencing instability, and a flexion contracture.Radiographic imaging displayed lucency of the femoral component and patellar button and 12 degrees varus alignment of the tibial component.Approximately one year post implantation the patient underwent a revision for instability and malalignment.All components, except the patella, were revised without complication.

Event Description

It was reported a patient reports pain, intermittent swelling, and deformity since surgery and then began experiencing instability, and a flexion contracture.Radiographic imaging displayed lucency of the femoral component and patellar button and 12 degrees varus alignment of the tibial component.Approximately one year post implantation the patient underwent a revision for instability, arthrofibrosis, and malalignment.All components, except the patella, were revised without complication.During the surgery, cultures were taken and later, one of the cultures from the femoral membrane, grew evidence of propionibacterium acnes.The patient was placed on a three month course of oral doxycycline.The patient has continued through the study without ongoing infection related complications.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: (b)(6) articular surface medial congruent (mc) right 10 mm lot# 64119302 mdr: 3007963827-2024-00031.(b)(6) femur trabecular metal cruciate retaining (cr) standard porous lot# 64317789 mdr: 0001822565-2024-00497.(b)(6) persona 2.5 mm female hex screw 25 mm length lot# 64591627 mdr: 0001822565-2024-00949.

• Brand Name: PERSONA TIBIA TRABECULAR METAL 2-PEG POROUS FXD BRG RT SIZE H
• 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: 18697277
• MDR Text Key: 335266127
• Report Number: 0001822565-2024-00496
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 03/18/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530008302
• Device Lot Number: 64077392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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 Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White