MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VANGUARD FEMORAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Osteopenia/ Osteoporosis (2651); Joint Laxity (4526)

Event Date 05/02/2020

Event Type  Injury  

Event Description

It was reported that a patient was revised due to pain, instability, stiffness, and laxity.During the revision, the tibia, femur, and art surface were replaced.The operative report states patient had diffuse laxity of the medical side of the knee and very soft bone.Cancellous bone loss in the tibia was also noted.Attempts to obtain additional information have been made; however, no more information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2022-02788, 0001825034-2022-02790.Initial surgery took place in 2015.Medical product: unknown vanguard articular surface.Unknown vanguard tibial tray.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 - component code - proposed code is mechanical (g04) - femur.Review of medical records confirmed the patient underwent a revision for medial laxity with cancellous tibial bone loss.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN VANGUARD FEMORAL
• 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: 15979618
• MDR Text Key: 305457920
• Report Number: 0001825034-2022-02789
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White