MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD SSK PSC TIB BRG 12X63/67; PROSTHESIS, KNEE

Model Number	183862
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign: (b)(6).Product has been received by zimmer biomet and 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 that during a knee revision procedure, the metallic part of the bearing insert broke while being implanted.The fractured product was removed and a second device was inserted.There was no impact to the patient.Attempts have been made and no additional information has been provided.
Event or Problem Description
Upon receiving additional information of the reported event, this device was determined to be not reportable.Based on analysis, the locking bar component of the tibial tray is the fractured device that led to the patient's revision.The initial report should be voided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receiving additional information of the reported event, this device was determined to be not reportable.Based on analysis, the locking bar component of the tibial tray is the fractured device that led to the patient's revision.The initial report should be voided.

• Brand Name: VNGD SSK PSC TIB BRG 12X63/67
• 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: 12857095
• Report Number: 0001825034-2021-03163
• Device Sequence Number: 4018217
• Product Code: JWH
• UDI-Device Identifier: 00880304441361
• UDI-Public: (01)00880304441361(17)240731(10)553800
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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: 07/31/2024
• Device Model Number: 183862
• Device Catalogue Number: 183862
• Device Lot Number: 553800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• 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: 10/27/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose