MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUAD UNV CR TIB TRL 71/75X10; INSTRUMENT, 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	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the poly trial broke on removal after completing final trial.No impact to patient or delay of case was reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or no photographs were provided; visual and dimensional evaluations could not be performed.Review of device history records identified no related deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.No medical records were provided.This complaint cannot be confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.
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 following sections were updated/corrected updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h11.Visual inspection of the returned device exhibits signs of use (nicks, gouges) and the trial is fractured.Not all fractured pieces were returned.Performed dimensional analysis and results are within specifications.Fracture surface of the returned device found artifacts of hackle marks and river lines suggest the overload failure mode.Review of device history records identified no related deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.No medical records were provided.This complaint is confirmed via product evaluation.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: VANGUAD UNV CR TIB TRL 71/75X10
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19373952
• Report Number: 0001825034-2024-01332
• Device Sequence Number: 18061847
• Product Code: JWH
• UDI-Device Identifier: 00887868490811
• UDI-Public: (01)00887868490811(10)ZB160403
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2025

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: 32-483740
• Device Lot Number: ZB160403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 05/13/2025
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 09/05/2024; 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female