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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT 62.5 PROSTHESIS KNEE Back to Search Results
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.
 
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Brand NameVANGUARD CR ILOK FEM-RT 62.5
Type of DevicePROSTHESIS 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 Key15074333
MDR Text Key296300627
Report Number0001825034-2022-01669
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 Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number183006
Device Lot NumberJ6462776
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/25/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/21/2022 Patient Sequence Number: 1
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