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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP SRS LR REV PRX BDY IMPACT EXTREMITIES, INSTRUMENT

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ZIMMER BIOMET, INC. COMP SRS LR REV PRX BDY IMPACT EXTREMITIES, INSTRUMENT Back to Search Results
Catalog Number 405231
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: (b)(6). 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
The instrument fractured during impaction. No adverse events have been reported as a result of the malfunction.
 
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Brand NameCOMP SRS LR REV PRX BDY IMPACT
Type of DeviceEXTREMITIES, INSTRUMENT
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 Key8797546
MDR Text Key151297707
Report Number0001825034-2019-03005
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K111746
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number405231
Device Lot Number345960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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