MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CR TIBIAL 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	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device fractured.No further information is available.
Additional Manufacturer Narrative
(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H4: proposed component (annex g) code is mechanical (g04) - provisional top.Complaint sample was evaluated.Visual evaluation of the returned device shows signs of repeated use and has fractured through the middle of the tasp.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was determined to be due to user error as it was incorrectly used with excessive force.The persona surgical technique (97-5026-001-00 rev.11, page 34, technique tip 11.C), apply gentle manual pressure without impacting the tasp construct with either a mallet or hand.The tasp construct includes the tasp top, bottom, shim, and tibial sizing plate handle.The tasp was struck with a mallet during the surgery which caused the fracture of the provisional; hence the root cause is attributed to user error/off label use.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 further event information available at the time of this report.

• Brand Name: PERSONA CR TIBIAL 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: 14989108
• Report Number: 0001822565-2022-02039
• Device Sequence Number: 1613852
• Product Code: JWH
• UDI-Device Identifier: 00889024238527
• UDI-Public: (01)00889024238527(10)63858432
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• 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): 08/03/2022

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: 42517000610
• Device Lot Number: 63858432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2017
• 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
• 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
• Patient Sex: Unknown