MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VG 360 5N1 LK TIB TRL 59X10; INSTRUMENT, KNEE

Model Number	32-360500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical product: vg 360 5n1 lk tib trl 59x12: catalog#32360502, lot#631310 foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-02854.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.
Event or Problem Description
It was reported that during a warehouse inspection a loaner set of tibial trial bearings were found to be cracked.There was no patient involvement.
Additional Manufacturer Narrative
Visual examination of the returned device found signs of repeated use and the trial is cracked in between the condyle features.Device history record was reviewed and no discrepancies related to the reported event were found.A complaint history review was conducted and identified no additional similar complaints for this part and lot combination.Root cause was unable to 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 at time of this report.

• Brand Name: VG 360 5N1 LK TIB TRL 59X10
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12616601
• Report Number: 0001825034-2021-02855
• Device Sequence Number: 1348934
• Product Code: JWH
• UDI-Device Identifier: 00880304516335
• UDI-Public: (01)00880304516335(11)171220(10)581080
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: 32-360500
• Device Catalogue Number: 32360500
• Device Lot Number: 581080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2017
• 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: Unknown