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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TRILOGY SHELL WITH CLUSTER HOLES
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ZIMMER TRILOGY SHELL WITH CLUSTER HOLES Back to Search Results
Catalog Number 00620005822
Device Problems Failure To Adhere Or Bond (1031); Corroded (1131)
Patient Problem Pain (1994)
Event Date 11/05/2013
Event Type  Injury  
Event Description
It is reported that the patient was revised due to loosening of the shell.During the revision corrosion, metallosis and a pseudotumor were noted.
 
Manufacturer Narrative
Information was received from a consumer who is not required to complete form 3500a.This report was previously submitted under 1822565-2011-00438.This report will be amended when our investigation is complete.
 
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Brand Name
TRILOGY SHELL WITH CLUSTER HOLES
Manufacturer (Section D)
ZIMMER
route 1, km. 123.4, bldg. 1
turpeaux industrial park
mercedita PR 00715
Manufacturer Contact
kevin escapule
po box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key4407116
MDR Text Key5431150
Report Number2648920-2015-00003
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/14/2017
Device Catalogue Number00620005822
Device Lot Number60813830
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/11/2014
Initial Date FDA Received01/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MANUFACTURED BY ZIMMER INC., WARSAW, IN; VERSYS FEMORAL HEAD; CATALOG #00801804001, LOT #60847657; ZIMMER M/L TAPER FEMORAL STEM; CATALOG #00771101000, LOT #60718331; AND REMAINS IMPLANTED.
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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