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 Insufficient Information (4580)

Event Date 11/06/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: unknown vanguard femoral component: catalog#ni, lot#ni; unknown vanguard tibial tray: catalog#ni, lot#ni.G2: foreign: germany.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the patient consent for product return has not been received.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient underwent revision surgery due to wear of the articular surface.The inlay was replaced without reported incident.Due diligence is complete as multiple attempts have been made however it was reported that no further information is available.

Manufacturer Narrative

Visual examination of the returned product identified wear and damage on both condyles.The distal side also shows signs of wear.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Complaint sample was evaluated and the reported event was confirmed.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 Description

No further event information at time of this report.

• 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: 18307716
• MDR Text Key: 330228715
• Report Number: 0001825034-2023-02954
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304271067
• UDI-Public: (01)00880304271067(17)220321(10)194770
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K171054
• 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: 03/29/2024

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: 03/21/2022
• Device Catalogue Number: 183422
• Device Lot Number: 194770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose