PIP SZ. 40 PROXIMAL PIP-200-40P-WW

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 2011-11-29 for PIP SZ. 40 PROXIMAL PIP-200-40P-WW manufactured by Ascension Orthopedics.

Event Text Entries

[2435599] The reporter stated a revision surgery was performed. The surgeon had to replace the index and middle finger with a larger implant. The joint was loose. All other implants are fine. The surgeon was satisfied with the post operative x-ray.
Patient Sequence No: 1, Text Type: D, B5


[9630474] The device involved in the reported incident is not expected to be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1651501-2011-00092
MDR Report Key2453667
Report Source08
Date Received2011-11-29
Date of Report2011-11-29
Date of Event2011-11-04
Date Mfgr Received2011-11-09
Date Added to Maude2012-02-17
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 ContactMARIA D'AGOSTINO
Manufacturer Street315 ENTERPRISE DR.
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePIP SZ. 40 PROXIMAL
Generic NamePIP
Product CodeKWF
Date Received2011-11-29
Catalog NumberPIP-200-40P-WW
Lot Number11-1901 REVISED PRODUCT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASCENSION ORTHOPEDICS
Manufacturer AddressAUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2011-11-29

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