PFC C/R FEM POR LFT SZ4 864107

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 2014-09-22 for PFC C/R FEM POR LFT SZ4 864107 manufactured by Depuy-raynham, A Div. Of Depuy Orthopaedics 12196.

Event Text Entries

[4836367] Patient was revised to address femoral loosening. Disassociation of the insert and tray was also reported.
Patient Sequence No: 1, Text Type: D, B5


[12174243] 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.
Patient Sequence No: 1, Text Type: N, H10


[12572402] Additional narrative: the device associated with this report was not returned. A complaint database search finds no other reported incidents against the provided product and lot combination. Requests for additional investigational inputs were made in accordance with wi-7915 appendix a. No additional information was obtained. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the inability to identify root cause, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should the 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 Number1818910-2014-28551
MDR Report Key4107108
Report Source05,08
Date Received2014-09-22
Date of Report2014-09-16
Date of Event2014-09-16
Date Mfgr Received2014-11-18
Device Manufacturer Date1995-05-12
Date Added to Maude2014-09-22
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 FDA0
Event Location0
Manufacturer ContactSTEVE DOWELL
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46581
Manufacturer CountryUS
Manufacturer Postal46581
Manufacturer Phone5743714918
Manufacturer G1DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 12196
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePFC C/R FEM POR LFT SZ4
Generic NameKNEE FEMORAL COMPONENT
Product CodeHSA
Date Received2014-09-22
Catalog Number864107
Lot Number010819
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 12196
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-09-22

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