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

Catalog Number 183422

Device Problem Material Erosion (1214)

Patient Problem Joint Laxity (4526)

Event Date 10/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: polished finned tib tray 67mm: catalog#141252, lot#2017100767; vanguard cr ilok fem-lt 62.5: catalog#183026, lot#j6079533; series a pat thn 31 3 peg: catalog#184784, lot#466490.G2: foreign: australia.The product will not be returned to zimmer biomet for investigation, as the product was not returned by the clinic.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported a patient underwent an initial total knee procedure.Subsequently, five (5) years and ten (10) months post-implantation, the patient underwent revision surgery due to instability and wear of the articular surface.All components were replaced with an alternative system without complication.It was reported that no further information is available.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: visual examination of the provided pictures identified sign of use and articular surface was worn.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was confirmed by review of provided photographs.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.

• Brand Name: VNGD CR TIB BRG 12X63/67
• 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: 18066597
• MDR Text Key: 327302896
• Report Number: 0001825034-2023-02563
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113550
• 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,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 183422
• Device Lot Number: 724390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG