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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE
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ZIMMER, INC. ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE Back to Search Results
Catalog Number 00584202608
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2015
Event Type  malfunction  
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It is reported that the articular surface would not seat with the tibial component.
 
Manufacturer Narrative
This report is being amended to reflect changes.Other device used: catalog #00584200602, nexgen zuk precoat tibial component, lot # 62403426.Review of the device history records did not find any deviations or anomalies.This device is used for treatment.A product history search revealed no additional complaints against the related part and lot combinations.A definitive root cause cannot be determined with the information provided.However, the complaint may be revised upon return of product or further information.
 
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Brand Name
ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE
Manufacturer (Section D)
ZIMMER, INC.
p.o box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
p.o box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5011841
MDR Text Key23446961
Report Number1822565-2015-01481
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Report Date 07/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2019
Device Catalogue Number00584202608
Device Lot Number61720373
Was Device Available for Evaluation? No
Date Manufacturer Received09/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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