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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual inspection of the returned provisional confirmed that the device was cracked and the devices exhibits signs of usage ( nicks, gouges).Dimensional analysis performed shows that the device is within specification.The dhr was reviewed and no discrepancies relevant to the reported event were found.The device was manufactured on september 12, 2017 and has therefore been in the field for approximately two years and six months.It is unknown for how many times the device is being used.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 that the rep noticed a crack in the trial after the disinfecting process.There was no patient involvement.

• Brand Name: ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE D 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: 10270377
• Report Number: 0001825034-2020-02755
• Device Sequence Number: 16998435
• Product Code: HSX
• UDI-Device Identifier: 00880304809789
• UDI-Public: (01)00880304809789
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/14/2020

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: 42518100408
• Device Lot Number: 63794225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1