MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VG 360 5N1 LK TIB TRL 79/83X10; PROSTHESIS 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	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned because product location is unknown.Reported event was confirmed by review of pictures provided.Visual evaluation of the device pictures shows signs of repeated use and a piece has fractured off.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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
It was reported that the device was fractured during trialing.The knee was very tight and the device fractured while the surgeon was trying to remove it from the patient.Attempt for further information has been made, but no further information has been provided.

• Brand Name: VG 360 5N1 LK TIB TRL 79/83X10
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11945920
• Report Number: 0001825034-2021-01713
• Device Sequence Number: 16408595
• Product Code: MBV
• UDI-Device Identifier: 00880304515994
• UDI-Public: (01)00880304515994(11)180910(10)352630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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: 32-360560
• Device Lot Number: 352630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/07/2021
• 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