MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE H 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer had indicated that the product was being returned to zimmer biomet for investigation, but it has not yet been received.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported articular surface provisional size 8mm, cracked when removing after final trialing.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the returned provisional confirmed that the device was cracked and the devices exhibits signs of usage.The dhr was reviewed and no discrepancies relevant to the reported event were found.The device has been in the field for approximately two years and eleven months.It is unknown for how many times the device is being used.A definitive 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
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE H 8 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10506979
• Report Number: 0001822565-2020-03171
• Device Sequence Number: 3138872
• Product Code: HSX
• UDI-Device Identifier: 00880304810020
• UDI-Public: (01)00880304810020
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 42518100808
• Device Lot Number: 63791075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/02/2020
• 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