MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 8MM 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	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a provisional fractured during a knee procedure.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported a provisional fractured during insertion as part of a knee procedure.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of repeated use (nicks, gouges) and is cracked.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.The root cause of the reported issue is attributed to wear and tear from the 5+ years of use in the field.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
No further event information available at the time of this report.

• Brand Name: 8MM THICKNESS SIZE F MEDIAL ARTICULAR SURFACE PROVISIONAL
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): .; 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: 16776205
• Report Number: 0001825034-2023-00857
• Device Sequence Number: 17896171
• Product Code: HSX
• UDI-Device Identifier: 00880304809901
• UDI-Public: (01)00880304809901(10)63801090
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

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: 42518100608
• Device Lot Number: 63801090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 05/10/2023; 08/02/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/06/2023; 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2017
• 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: Female