MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG; PROSTHESIS KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arthritis (1723); Insufficient Information (4580)

Event Date 10/12/2021

Event Type  Injury  

Event Description

It was reported patient underwent a revision procedure four years post implantation due to unknown reason in knee.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4).D10 ¿ medical product: series a pat thn 34 3 peg catalog # 184786 lot # 361710.Biomet cc cruciate tray 71mm catalog # 141233 lot # j3842692.Vngd ps open intl fem rt 60 catalog # 183104 lot # j3882188.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2023-01750, 0001825034-2023-01753, 0001825034-2023-01755, h3 other text : product location unknown.

Event Description

Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.There is no issues with zimmer biomet device, as the event was the result of a patient condition.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.There is no issues with zimmer biomet device, as the event was the result of a patient condition.The initial report was forwarded in error and should be voided.

• Brand Name: E1 VNGD PS TIB BRG
• 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: 17408391
• MDR Text Key: 319895844
• Report Number: 0001825034-2023-01754
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00880304465701
• UDI-Public: (01)00880304465701(17)210412(10)772640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-183642
• Device Lot Number: 772640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2016
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female