CEMENTRALIZER 12.0 137621000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-12-15 for CEMENTRALIZER 12.0 137621000 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[62483896] This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[62483897] Patient was revised to address an acetabular bone fracture and cup loosening. The stem was also noted to be loose. Loosening occurred at the cement to femoral stem interface. Cement manufacturer is unknown.
Patient Sequence No: 1, Text Type: D, B5


[66151077] No device associated with this report was received for examination. A worldwide complaint database search found no other related incident(s) against the provided product/lot combination(s) since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1818910-2016-33500
MDR Report Key6178242
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2016-12-15
Date of Report2016-12-07
Date of Event2016-12-07
Date Mfgr Received2018-06-26
Device Manufacturer Date2016-08-29
Date Added to Maude2016-12-15
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 ContactMR. CHAD GIBSON
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone5743725905
Manufacturer G1JTE WARSAW MFG SITE
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCEMENTRALIZER 12.0
Generic NameHIP OTHER IMPLANT
Product CodeLTO
Date Received2016-12-15
Catalog Number137621000
Lot NumberC74201
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-12-15

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.