MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGD VE CR TIB BRG 79/83X10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified debris visually consistent with hair.The packaging has been opened and was returned opened, therefore, the origin of the debris cannot be confirmed.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was returned opened.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 during a knee procedure, when the tibial insert packaging was opened, a hair was found on the implant.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: VGD VE CR TIB BRG 79/83X10MM
• Common Device Name: PROSTHESIS, 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: 13690081
• Report Number: 0001822565-2022-00659
• Device Sequence Number: 12085933
• Product Code: JWH
• UDI-Device Identifier: 00889024565050
• UDI-Public: (01)00889024565050(17)250713(10)64723315
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2022

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 Expiration Date: 07/13/2025
• Device Model Number: N/A
• Device Catalogue Number: VE183460
• Device Lot Number: 64723315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• 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: 02/18/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Sex: Male