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

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032)

Event Type  Injury  

Event Description

It was reported a patient underwent a left total knee arthroplasty.Patient discharged home following an uneventful hospital stay.Subsequently, the patient then felt a pinching and was unable to bend the knee.Radiographic imaging was insignificant.Customer claimed femoral loosening approximatley 10 years post implantation.No revision or intervention is planned.

Manufacturer Narrative

(b)(4).H6-component code- suggested code: mechanical g4-femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for the reported part and lot combinations.Initial surgery medical record were provided and reviewed by a health care professional.Review of the available records identified no complication during surgery.After the surgery, the rom was noted to tolerated.No other record were provided for further review of reported issue.Complaint is unconfirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products: ep-189044 e1 vngd as tib brg 14x67 lot# 964760.141232 biomet cc cruciate tray 67mm lot# j3068266.184766 series a pat std 34 3 peg lot# 219750.545035500 gentamicin bone cement lot# 3590933.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.

• Brand Name: VANGUARD CR ILOK FEM-LT 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: 16966268
• MDR Text Key: 315650877
• Report Number: 0001825034-2023-01131
• Device Sequence Number: 1
• Product Code: HRY
• 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: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: 183028
• Device Lot Number: 611940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2013
• 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