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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Range of Motion (2032); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
Event Date 05/11/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical product: vanguard as bearings catalog # 189103, lot # 260730; series a 3 peg std catalog # 184766, lot # 344500; biomet cc i-beam tray 79mm catalog # 141225, lot # j6724765. Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to 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: 0001825034-2020-02364, 0001825034-2020-02365.
 
Event Description
It was reported that the patient underwent an initial knee arthroplasty. Subsequently, the patient developed stiffness and ankylosis of the right knee requiring a manipulation. The adverse event was resolved. Attempt for further information has been made, but no further information has been provided.
 
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Brand NameVANGUARD CR ILOK FEM-RT
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 Key10171209
MDR Text Key196413406
Report Number0001825034-2020-02362
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number183010
Device Lot NumberJ6677379
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2019
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: 06/18/2020 Patient Sequence Number: 1
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