MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE E 8 MM THICKNESS DO NOT IMPLANT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual inspection of the returned trial confirmed that the device has fractured and the device exhibits signs of usage.Dimensional analysis performed found the device is within specification.The dhr was reviewed and no discrepancies relevant to the reported event were found.No medical records were provided.The device was manufactured on (b)(6) 2018 and has been in the field for approximately one year and ten months.It is unknown for how many times the device is has been used.Based on the information available, a root cause cannot be determined.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 during the initial total knee arthroplasty the articular surface provisional fractured when surgeon removed it.No adverse events have been reported as a result of the malfunction.

• Brand Name: ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE E 8 MM THICKNESS DO NOT IMPLANT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10111622
• Report Number: 0001825034-2020-02209
• Device Sequence Number: 11614683
• Product Code: HSX
• UDI-Device Identifier: 00880304809840
• UDI-Public: 00880304809840
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

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: 42518100508
• Device Lot Number: 63904334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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