OXFORD PARTIAL KNEE SYSTEM 506269

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-09 for OXFORD PARTIAL KNEE SYSTEM 506269 manufactured by Biomet Orthopedics.

Event Text Entries

[27980393]
Patient Sequence No: 1, Text Type: N, H10


[27980394] Biomet oxford blade for stryker system does not latch into stryker system 7.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5140062
MDR Report Key5140062
Date Received2015-10-09
Date of Report2015-10-05
Date of Event2015-10-05
Report Date2015-10-05
Date Reported to FDA2015-10-05
Date Reported to Mfgr2015-10-05
Date Added to Maude2015-10-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOXFORD PARTIAL KNEE SYSTEM
Generic NameBLADE, SAW
Product CodeHSO
Date Received2015-10-09
Model Number506269
Catalog Number506269
Lot NumberP424336
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET ORTHOPEDICS
Manufacturer Address56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581 US 46581


Patients

Patient NumberTreatmentOutcomeDate
10 2015-10-09

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