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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT INSTRUMENT, KNEE

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ZIMMER, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Upon reassessment, it was determined that the product issue is not associated with the reported complaint. The report was sent in error and should be voided.
 
Event Description
It is reported that the device is fractured.
 
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Brand NamePERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT
Type of DeviceINSTRUMENT, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6312100
MDR Text Key163008239
Report Number0001822565-2017-00703
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 10/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42527600810
Device Lot Number63168612
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/22/2015
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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