CEMENTRALIZER 14.0 137636000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2005-06-10 for CEMENTRALIZER 14.0 137636000 manufactured by Depuy Orthopaedics, Inc..

Event Text Entries

[371607] The pt was revised due to infection of the hip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2005-00849
MDR Report Key612659
Report Source05,08
Date Received2005-06-10
Date of Report2005-06-03
Date of Event2005-06-03
Date Facility Aware2005-06-03
Report Date2005-06-03
Date Mfgr Received2005-06-03
Device Manufacturer Date2004-06-01
Date Added to Maude2005-06-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactGINNY STAMBERGER, MGR
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone5743727333
Manufacturer G1DEPUY ORTHOPAEDICS, INC.
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46581098
Manufacturer CountryUS
Manufacturer Postal Code46581 0988
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCEMENTRALIZER 14.0
Generic NameTOTAL HIP REPLACEMENT
Product CodeLTO
Date Received2005-06-10
Model NumberNA
Catalog Number137636000
Lot NumberYR8A21000
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age3 MO
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key602487
ManufacturerDEPUY ORTHOPAEDICS, INC.
Manufacturer Address700 ORTHOPAEDIC DR. WARSAW IN 465810988 US
Baseline Brand NameCEMENTRALIZER 14.0
Baseline Generic NameCEMENT SPACER
Baseline Model NoNA
Baseline Catalog No137636000
Baseline IDNA
Baseline Device FamilyCEMENTRALIZERS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK871510
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2005-06-10

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