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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CALIBRATED FLEXIBLE DEPTH GAGE E INSTRUMENT, HIP

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ZIMMER BIOMET, INC. CALIBRATED FLEXIBLE DEPTH GAGE E INSTRUMENT, HIP Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that depth gauges broke during an initial tha. Physician bent depth gauges and broke them. Attempts have been made and no further information has been provided.
 
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Brand NameCALIBRATED FLEXIBLE DEPTH GAGE E
Type of DeviceINSTRUMENT, HIP
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 Key10757856
MDR Text Key213863095
Report Number0001825034-2020-03939
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number424492
Device Lot Number675360
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2013
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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