MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG LL 12X63; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00281 and 0001825034-2024-00283.D10 medical devices: vngd xp cr intlk tib tray 63mm, catalog#: 195269, lot#: 065420.Vgxp as e1 tib brg lm/rl 10x63, catalog#: 195536, lot#: 393870.G2 foreign source: japan.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 Description

It was reported that patient underwent a knee revision approximately four years post-implantation due to the locking bar backing out.No additional patient consequences were reported.

• Brand Name: VGXP XP E1 TIB BRG LL 12X63
• Type of Device: PROSTHESIS, 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: 18629717
• MDR Text Key: 334421090
• Report Number: 0001825034-2024-00282
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00880304552753
• UDI-Public: (01)00880304552753(17)240809(10)299050
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 195810
• Device Lot Number: 299050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female