MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL TRAY RIGHT SIZE F; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona trabecular metal cruciate retaining standard porous femoral component catalog #: 42502806602 lot #: ni, 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: 0001822565-2023-03804.0001822565-2023-03807.H3 other text : investigation incomplete.
Event or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b3, b4, b5, d6, g3, g6, h2, and h10.
Event or Problem Description
It was reported that patient underwent a right knee revision approximately eight months post-implantation due to aseptic loosening of the tibial tray.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed due to lack of proficient information; no product, pictures, or medical records were provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information to report.

• Brand Name: PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL TRAY RIGHT SIZE F
• 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: 18400495
• Report Number: 0001822565-2023-03807
• Device Sequence Number: 2804724
• Product Code: MBH
• UDI-Device Identifier: 00889024510586
• UDI-Public: (01)00889024510586(17)320519(10)65405331
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2024

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: 42530007502
• Device Lot Number: 65405331
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 04/04/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 02/26/2024; 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male