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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VAN PS OPEN INTL FEM-LT 60 PROSTHESIS KNEE

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ZIMMER BIOMET, INC. VAN PS OPEN INTL FEM-LT 60 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 04/19/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Birth year ¿ 1956. Concomitant medical products - medical product: vngd ps tib brg 10x63/67mm, catalog # 183620, lot # 835790; polished finned tib tray 63mm, catalog # 141251, lot # 2017070093. Report source: italy. Customer has indicated that the product will not be returned because product location is unknown. 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: 0001825034-2022-01559.
 
Event Description
It was reported patient underwent a revision procedure sixteen months post implantation due to pain and functional limitation. Attempts to obtain additional information have been made; however, no more is available at this time.
 
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Brand NameVAN PS OPEN INTL FEM-LT 60
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 Key14930553
MDR Text Key295328718
Report Number0001825034-2022-01558
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K113550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number183124
Device Lot Number6090250
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2017
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: 07/06/2022 Patient Sequence Number: 1
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