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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD UNV CR TIB TRL 71/75X10 INSTRUMENT KNEE

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ZIMMER BIOMET, INC. VNGD UNV CR TIB TRL 71/75X10 INSTRUMENT KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical product: 1/8 quick rel drl sterile 2pk catalog # 32-486265 lot # 058990, vanguard cr ilok fem-lt 62. 5 catalog # 183026 lot # j7101349, biomet cc cruciate tray 71mm catalog # 141233 lot # j7151149, series a asymmetric pat 31x8 catalog # 184792 lot # 799030, vgd ve as tib brg 71x10mm catalog # ve189060 lot # 65268838. The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch will be submitted.
 
Event Description
It was reported that the device was fractured during trialing. Attempts to obtain additional information have been made; however, no more is available.
 
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Brand NameVNGD UNV CR TIB TRL 71/75X10
Type of DeviceINSTRUMENT 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 Key13587905
MDR Text Key286775403
Report Number0001825034-2022-00380
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,Followup
Report Date 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32-483740
Device Lot NumberZB161101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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