MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT 62.5; PROSTHESIS KNEE

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported patient is experiencing pain, instability and popping in knee approximately 3 years post implantation.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Medical product: e1 vngd as tib brg 13x71 catalog # ep-189063 lot # 315520; biomet cc i-beam tray 71mm catalog # 141223 lot # j6453610; series a pat std 34 3 peg catalog # 184766 lot # 641100.Customer has indicated that the product will not be returned because it remains implanted.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: 0001825034-2022-01661; 0001825034-2022-01673; 0001825034-2022-01675.

• Brand Name: VANGUARD CR ILOK FEM-RT 62.5
• 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: 15074333
• MDR Text Key: 296300627
• Report Number: 0001825034-2022-01669
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304270398
• UDI-Public: (01)00880304270398(17)281225(10)J6462776
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• 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: 183006
• Device Lot Number: J6462776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/25/2018
• 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): Other
• Patient Sex: Female
• Patient Weight: 77 KG