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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEW ULNAR REVISION KIT JDC

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ZIMMER, INC. NEW ULNAR REVISION KIT JDC Back to Search Results
Catalog Number 32810502900
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 05/04/2016
Event Type  Injury  
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It is reported that a patient was revised due to infection.
 
Manufacturer Narrative
No devices or photos were received; therefore the condition of the components is unknown. Review if the device history records did not find any deviations or anomalies. These devices are used for treatment. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Product history search revealed no additional complaints against the related part and lot combinations. Patient¿s adherence to rehabilitation protocol is unknown. Single-use, sterilized devices manufactured or distributed by (b)(4) are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1. 0 x 10-6 or better. Therefore, it is highly unlikely that the specified device caused or contributed to any patient infection. A definite root cause cannot be determined with the information provided.
 
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Brand NameNEW ULNAR REVISION KIT
Type of DeviceJDC
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 Key5689129
MDR Text Key46221219
Report Number0001822565-2016-01856
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
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 05/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2010
Device Catalogue Number32810502900
Device Lot Number60300924
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 Received08/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2005
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: 05/31/2016 Patient Sequence Number: 1
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