RHEO KNEE 3 RKN130003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-29 for RHEO KNEE 3 RKN130003 manufactured by Ossur Hf.

Event Text Entries

[134336212] The patient fell and broke his ribs.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003764610-2019-00002
MDR Report Key8284877
Report SourceHEALTH PROFESSIONAL
Date Received2019-01-29
Date of Report2019-03-12
Date Mfgr Received2018-11-02
Date Added to Maude2019-01-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATLA AXELSDOTTIR
Manufacturer StreetGRJOTHALS 1-5
Manufacturer CityREYKJAVIK, 110
Manufacturer CountryIC
Manufacturer Postal110
Single Use3
Remedial ActionPM
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRHEO KNEE 3
Generic NamePROSTHETIC KNEE
Product CodeISW
Date Received2019-01-29
Model NumberRKN130003
Catalog NumberRKN130003
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOSSUR HF
Manufacturer AddressGRJOTHALS 1-5 REYKJAVIK, 110 IC 110


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-01-29

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