MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 10X79/83; PROSTHESIS, KNEE

Catalog Number 183460

Device Problem Material Erosion (1214)

Patient Problem Insufficient Information (4580)

Event Date 01/16/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, six (6) years and eight (8) months post-implantation, the patient underwent revision surgery due to wear of the articular surface.The bearing was exchanged without reported complication.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

(b)(4).Date of implant: exact date of implant is unknown however occurred in (b)(6) 2017.Medical product: unknown femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni.G2: foreign: germany.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: VNGD CR TIB BRG 10X79/83
• 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: 18685644
• MDR Text Key: 335130437
• Report Number: 0001825034-2024-00375
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304271210
• UDI-Public: (01)00880304271210(17)220317(10)990770
• 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: 04/30/2024

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: 03/17/2022
• Device Catalogue Number: 183460
• Device Lot Number: 990770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 99 KG