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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC TRILOGY SHELL WITH MULTI HOLES; LZO

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ZIMMER INC TRILOGY SHELL WITH MULTI HOLES; LZO Back to Search Results
Catalog Number 00875305002
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 10/19/2010
Event Type  Injury  
Manufacturer Narrative
(b)(4).This report will be amended when our investigation is complete.
 
Event Description
It is reported the patient was revised due to aseptic loosening.
 
Manufacturer Narrative
No device or photos were received; therefore the condition of the device is unknown.Review of the device history record did not find any deviations or anomalies.This device is 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 combination.Patient activity level and adherence to rehabilitation protocol is unknown.A definite root cause cannot be determined with the information provided.
 
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Brand Name
TRILOGY SHELL WITH MULTI HOLES
Type of Device
LZO
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 Key5303242
MDR Text Key33663574
Report Number1822565-2015-02662
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/19/2015
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 Catalogue Number00875305002
Device Lot Number62811618
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/19/2015
Initial Date FDA Received12/16/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2014
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 Outcome(s) Required Intervention;
Patient Age78 YR
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