MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT 65; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Muscle Weakness (1967); Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 07/06/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2024-00270, 0001825034-2024-00272, and 0001825034-2024-00273.D10-medical product: tibial bearing (as) 71 mm width 14 mm thickness, item# ve189064, lot# 64469192.Series a pat std 25 3 peg, item# 184760, lot# 807800.Biomet cc cruciate tray 71mm, item# 141233, lot# j6869986.Bone screw self-tapping 6.5 mm dia.25 mm length, item# 00625006525, lot# 64611734 qty (b)(4).Biomet bc r 1x40 us, item# 110035368, lot# f2701z12ba, qty (b)(4).H3- 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.

Event Description

It was reported that a patient was revised approximately two years and four months post implantation due to pain, instability, effusions, and patella impingement with malalignment.Attempts to obtain additional information have been made; however, no more information is available.

• Brand Name: VANGUARD CR ILOK FEM-RT 65
• 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: 18623309
• MDR Text Key: 334328022
• Report Number: 0001825034-2024-00271
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304270404
• UDI-Public: (01)00880304270404(17)301130(10)J6917396
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183008
• Device Lot Number: J6917396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2020
• 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: Female
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American