PFC C/R FEM POR RT SZ5 864104

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 2013-12-23 for PFC C/R FEM POR RT SZ5 864104 manufactured by 1219655 Depuy-raynham, A Div. Of Depuy Orthopaedic.

Event Text Entries

[11490606] If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The device associated with this report was not returned. Review of supplied x-rays did not find evidence of device loosening. Requests for additional investigational inputs were made in accordance with wi-7915 appendix a. No additional information was obtained. A complaint database search finds no other reported incidents against the provided product and lot combination. The investigation could not verify or identify any product contribution to the reported loosening 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 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


[15153879] Patient was revised to address loosening of the tibial tray at both interfaces due to significant osteolysis secondary to poly wear. Competitor cement was used at the time of original implantation. Loosening of the femoral component was also reported.
Patient Sequence No: 1, Text Type: D, B5


[15420931] This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1818910-2013-36835
MDR Report Key3534243
Report Source05,08
Date Received2013-12-23
Date of Report2013-12-09
Date of Event2013-12-09
Date Mfgr Received2014-01-30
Device Manufacturer Date1994-03-24
Date Added to Maude2013-12-23
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 ContactSTACEY TRICK
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46581
Manufacturer CountryUS
Manufacturer Postal46581
Manufacturer Phone5743714554
Manufacturer G11219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
Manufacturer Street325 PARAMOUNT DR.
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePFC C/R FEM POR RT SZ5
Generic NameFEMORAL KNEE PROSTHESIS
Product CodeHSA
Date Received2013-12-23
Catalog Number864104
Lot Number161BW
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
Manufacturer Address325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-12-23

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