COONRAD/MORREY PIVOT PIN 32-8106-000-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-28 for COONRAD/MORREY PIVOT PIN 32-8106-000-10 manufactured by Zimmer, Inc..

Event Text Entries

[20061726] C-ring became loose allowing the pivot pin to back out. Surgeon also replaced the ulnar portion to the elbow (32-8105-001).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1826933-1995-00004
MDR Report Key26315
Date Received1995-08-28
Date of Report1995-08-25
Date of Event1995-08-24
Date Facility Aware1995-08-24
Report Date1995-08-25
Date Reported to FDA1995-08-25
Date Reported to Mfgr1995-08-25
Date Added to Maude1995-10-02
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCOONRAD/MORREY PIVOT PIN
Generic NamePIVOT PIN
Product CodeKWJ
Date Received1995-08-28
Model NumberNA
Catalog Number32-8106-000-10
Lot Number33774200
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeUNKNOWN
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key26987
ManufacturerZIMMER, INC.
Manufacturer Address1777 W CTR ST WARSAW IN 46580 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1995-08-28

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