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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER FIBULAR PLATE TRAUMA PROSTHESIS

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ZIMMER, INC. UNKNOWN ZIMMER FIBULAR PLATE TRAUMA PROSTHESIS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Information was received via journal article. Please reference literature at the following location: https://www. Researchgate. Net/publication/276428518_total_ankle_replacement_through_a_lateral_approach. This report will be amended when our investigation is complete.

 
Event Description

It is reported that a patient underwent a fibular plate removal due to an unknown reason.

 
Manufacturer Narrative

The device history records for the fibular plate could not be reviewed for deviations and/or anomalies as no lot numbers were provided. No product was returned for review. This device is used for treatment. A product history search could not be conducted as no lot numbers or part numbers were provided. The reviewed article was not clear about the fibular plate used, or the specific manufacturer and/or design owner. A follow-up was attempted to determine why the fibular plate was removed (e. G. , problems experienced or routine hardware removal after the plate had served its purpose) with no response. A definitive root cause for removal of the plate cannot be determined.

 
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Brand NameUNKNOWN ZIMMER FIBULAR PLATE
Type of DeviceTRAUMA PROSTHESIS
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
carrie schneider
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5882509
MDR Text Key52317545
Report Number0001822565-2016-02858
Device Sequence Number1
Product Code JDP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/17/2016 Patient Sequence Number: 1
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