MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 10MM THICKNESS SIZE C MEDIAL ARTICULAR SURFACE PROVISIONAL DO NOT IMPLANT; INSTRUMENT, KNEES

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned product shows sign of repeated use and is cracked / fractured.The device history record was reviewed and no discrepancies relevant to the reported event were found.The lot was manufactured on (b)(6) 2017 and has therefore been in the field for approximately five years and six months.It is unknown for how many times the device is being used.The root cause can be contributed to normal wear and tear of device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the trial poly surface broke during removal.There was no consequences or impact to the patient.No additional information is available at the time of this report.

• Brand Name: 10MM THICKNESS SIZE C MEDIAL ARTICULAR SURFACE PROVISIONAL DO NOT IMPLANT
• Common Device Name: INSTRUMENT, KNEES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16674183
• Report Number: 0001825034-2023-00746
• Device Sequence Number: 14789171
• Product Code: HSX
• UDI-Device Identifier: 00880304809741
• UDI-Public: (01)00880304809741(10)63791079
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 04/04/2023

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: 42518100310
• Device Lot Number: 63791079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• 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: 03/24/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2017
• 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: Reuse
• 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: Female