MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MC TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 8-11 EF TOP; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Will be returned.
Event or Problem Description
It was reported that surgeon was trialing with the left mc poly trail for final knee trial before opening implants.When he attempted to remove the poly trial from the joint, the posterior corner of the poly trial broke.The pieces were removed and the case continued without further interruption.No additional information available.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as the device was returned fractured.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental 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: MC TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 8-11 EF TOP
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10792486
• Report Number: 0001822565-2020-03735
• Device Sequence Number: 3267234
• Product Code: JWH
• UDI-Device Identifier: 00889024238657
• UDI-Public: (01)00889024238657(10)63179356
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 42517100810
• Device Lot Number: 63179356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 02/05/2021
• 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
• Patient Weight: 134