MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD ANT STAB BRG 13X79; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 183010 vanguard cr ilok fem-rt 67.5 lot# j7215821.0001825034-2023-00419.Additional associated products 141314 biomet finned pri stem 40mm lot# 239970.141215 biomet ilok pri tib tray 79mm lot# 501280.184766 series a pat std 34 3 peg lot# 338010.

Event Description

It was reported a patient underwent an initial right total knee arthroplasty performed.Subsequently, the patient underwent a manipulation under anesthesia approximately 2 months post implantation.No further complications have been reported and patient remains satisfied.

• Brand Name: VNGD ANT STAB BRG 13X79
• 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: 16459788
• MDR Text Key: 310423864
• Report Number: 0001825034-2023-00420
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00880304674837
• UDI-Public: (01)00880304674837(17)260824(10)408490
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 189103
• Device Lot Number: 408490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2023
• Initial Date FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White