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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. TRABECULAR METAL SHELL WITH CLUSTER HOLES
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ZIMMER, INC. TRABECULAR METAL SHELL WITH CLUSTER HOLES Back to Search Results
Catalog Number 00620206022
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2013
Event Type  malfunction  
Event Description
It is reported that when the surgeon began inserting the liner into the cup he realized that there was no locking ring.The surgeon had to remove the cup.A second implant, that included the ring, was implanted.The surgery was delayed for about ten minutes while the first cup was removed and the second cup was retrieved.
 
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
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Brand Name
TRABECULAR METAL SHELL WITH CLUSTER HOLES
Manufacturer (Section D)
ZIMMER, INC.
po box 708
warsaw IN 46581 070
Manufacturer Contact
kevin escapule
po box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key3829150
MDR Text Key4451834
Report Number1822565-2014-00296
Device Sequence Number1
Product Code KWZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2023
Device Catalogue Number00620206022
Device Lot Number62490588
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/13/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received02/05/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
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