ASCENSION PIP PIP-200 PIP-200-10P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-03-31 for ASCENSION PIP PIP-200 PIP-200-10P manufactured by Ascension Orthopedics, Inc..

Event Text Entries

[826846] Device was removed from patient as it was "eroding through the skin". The surgeon noted that the erosion was not caused by operative tech or implants, but possible further degenerative rheumatoid arthritis.
Patient Sequence No: 1, Text Type: D, B5


[8048329] The implant components satisfied all applicable manufacturing specifications. The implants did not display any evidence of damage due to function over the approximately one year duration implant duration. There was no evidence to suggest that the distal implant surface chips had existed for a significant period of time.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1651501-2008-00007
MDR Report Key1023641
Report Source08
Date Received2008-03-31
Date of Report2008-03-31
Date of Event2008-01-23
Date Mfgr Received2008-02-20
Device Manufacturer Date2006-07-10
Date Added to Maude2009-04-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLYNN FERGUSON
Manufacturer Street8700 CAMERON ROAD STE. 100
Manufacturer CityAUSTIN TX 78754
Manufacturer CountryUS
Manufacturer Postal78754
Manufacturer Phone5128365001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASCENSION PIP
Generic NameTOTAL FINGER JOINT IMPLANT
Product CodeKWF
Date Received2008-03-31
Returned To Mfg2008-03-13
Model NumberPIP-200
Catalog NumberPIP-200-10P
Lot Number06-1220
ID NumberNA
Device Expiration Date2010-05-01
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASCENSION ORTHOPEDICS, INC.
Manufacturer Address8700 CAMERON ROAD STE. 100 AUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-03-31

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