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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 Pain (1994); Loss of Range of Motion (2032)
Event Date 09/21/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Year of birth ¿ 1954. Report source: (b)(6). Medical product: biomet cc cruciate tray catalog # 141233, lot # j6895411, vanguard cr tib brg catalog # 183442, lot # 380360. Device evaluated by mfr: 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: 0001825034-2022-01440.
 
Event Description
It was reported patient underwent a manipulation under anesthesia four months post implantation due to restricted flexion range of motion. Attempts to obtain additional information have been made; however, no more is available at this time.
 
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Brand NameVANGUARD CR ILOK FEM-RT
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 Key14798995
MDR Text Key294644670
Report Number0001825034-2022-01441
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K113550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number183006
Device Lot NumberJ6835509
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2020
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: 06/24/2022 Patient Sequence Number: 1
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