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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 70 PROSTHESIS KNEE

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ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 70 PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060)
Event Date 01/18/2021
Event Type  malfunction  
Event Description
It was reported patient had a manipulation under anesthesia due to limited range of motion and stiffness in knee forty eight days post implantation. Attempts to obtain additional information have been made; however, no more is available.
 
Manufacturer Narrative
(b)(4). Concomitant medical products - medical products: vngd ant stab brg 13x75 catalog # 189083 lot # 552740, biomet cc i-beam tray 75mm catalog # 141224 lot # j6785147. Customer has indicated that the product will not be returned because it remains implanted. Multiple mdr reports were filled for this event: (b)(4). According to tabers medical dictionary ¿ manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia. With anesthesia is (mua). Per clinical orthopaedics and related research (how to treat the stiff total knee arthroplasty? a systematic review), mua is used to treat and resolve arthrofibrosis (scar tissue). This procedure is performed to increase articular motion and reduce chronic pain from arthrofibrosis. The indication for manipulation under anesthesia is related to limited range of motion and stiffness due to adhesions/scar tissue. 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.
 
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Brand NameVANGUARD CR ILOK FEM-LT 70
Type of DevicePROSTHESIS KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key13694374
MDR Text Key287270905
Report Number0001825034-2022-00467
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number183032
Device Lot NumberJ6858698
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/08/2022 Patient Sequence Number: 1
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