MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD 360 5N1 LK TIBIAL TRIAL 10MM X 71/75MM; 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	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source - foreign: (b)(6).The complainant 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.Investigation incomplete.
Event or Problem Description
It was reported that during knee arthroplasty while the surgeon was trialing articular surface thickness, the trial was identified to be cracked upon removal.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint sample was evaluated through photographic inspection and the reported event was confirmed.Visual examination of the provided pictures found that a piece of the trial had fractured off.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint sample was returned and visual examination of the product identified signs of repeated use (chipped/gouged) and a piece had fractured off the distal surface.The device was submitted for further analysis and determined that the features of the fracture surface were consistent with bending overload.The root cause remains unchanged at this time.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: VANGUARD 360 5N1 LK TIBIAL TRIAL 10MM X 71/75MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11334174
• Report Number: 0001825034-2021-00512
• Device Sequence Number: 17082288
• Product Code: JWH
• UDI-Device Identifier: 00880304516106
• UDI-Public: (01)00880304516106(11)190117(10)107480
• 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,Followup,Followup
• Report Date (Section B): 09/09/2021

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: 32-360540
• Device Lot Number: 107480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/02/2021; 09/07/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/04/2021; 09/09/2021
• 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