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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD ANT STBLZD BRG 10X67 PROSTHESIS KNEE

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ZIMMER BIOMET, INC. VNGD ANT STBLZD BRG 10X67 PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 06/07/2022
Event Type  malfunction  
Event Description
It was reported patient underwent a revision procedure three months post implantation due to subsidence. Attempts to obtain additional information have been made; however, no more is available.
 
Manufacturer Narrative
(b)(4). Polished finned tib tray 67mm catalog # 141252; lot # 2021041410. Report source: united kingdom. Customer has indicated that the product will not be returned because requested but not returned by hospital. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned by hospital.
 
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Brand NameVNGD ANT STBLZD BRG 10X67
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 Key14695906
MDR Text Key294062099
Report Number0001825034-2022-01409
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUK
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
Type of Report Initial,Followup
Report Date 07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number189040
Device Lot Number759930
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2021
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: 06/15/2022 Patient Sequence Number: 1
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