MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA TM TWO-PEG POROUS FIXED BEARING LEFT SIZE D; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: articular surface medial congruent (mc) left 14 mm height catalog#: 42512100414 lot#: 64685906.Femur trabecular metal cruciate retaining (cr) standard porous catalog#: 42502806001 lot#: 64947183.All poly patella standard cemented size 32 mm diameter 8.5 mm thickness catalog#: 00597206532 lot#: 64774881.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a left knee revision approximately thirty-two (32) months post-implantation due to tibial tray loosening.No additional patient consequences were reported.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001822565-2024-01762.
Event or Problem Description
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001822565-2024-01762.

• Brand Name: PERSONA TIBIA TM TWO-PEG POROUS FIXED BEARING LEFT SIZE D
• Common Device Name: 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: 19392740
• Report Number: 0001822565-2024-01732
• Device Sequence Number: 20783530
• Product Code: MBH
• UDI-Device Identifier: 00889024246492
• UDI-Public: (01)00889024246492(17)310519(10)64963120
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530006701
• Device Lot Number: 64963120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Weight: 89 KG