MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA 9MM THICKNESS SIZE F MEDIAL ARTICULAR SURFACE PROVISIONAL; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the instrument was discovered fractured as it was removed from the tray.No harm or injury was reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified signs of use in the form of nicks and gouges.A fracture can be seen on the device but as it was not returned further evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Complaint is confirmed with the provided pictures.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Upon review of our reporting decision on fracture of articular surface provisionals.A review of all complaints for this product indicates that there has never been an event that has resulted in a death or serious injury.Therefore, zimmer biomet will not be reporting this failure mode going forward.This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h3, h4, h6, and h11.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: PERSONA 9MM THICKNESS SIZE F MEDIAL ARTICULAR SURFACE PROVISIONAL
• Common Device Name: INSTRUMENT, 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: 19284875
• Report Number: 0001822565-2024-01538
• Device Sequence Number: 12842228
• Product Code: HSX
• UDI-Device Identifier: 00880304809918
• UDI-Public: (01)00880304809918(10)63904350
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42518100609
• Device Lot Number: 63904350
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown