DIRECTINJECT ON DEMAND HA CEMENT 79-45905

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 2016-06-09 for DIRECTINJECT ON DEMAND HA CEMENT 79-45905 manufactured by Stryker Orthopaedics-limerick.

Event Text Entries

[46903930] Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device still implanted in patient.
Patient Sequence No: 1, Text Type: N, H10


[46903931] It was reported the around 4-6 weeks after initial surgery, the patient returned to the facility with aseptic meningitis, which was diagnosed based on symptoms alone.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008010177-2016-00121
MDR Report Key5709366
Report SourceHEALTH PROFESSIONAL
Date Received2016-06-09
Date of Report2017-09-29
Date of Event2016-04-27
Date Mfgr Received2016-05-10
Date Added to Maude2016-06-09
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 FDA3
Event Location3
Manufacturer ContactMR. KELLI DYKSTRA
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer PostalD-79111
Manufacturer Phone76145120
Manufacturer G1STRYKER ORTHOPAEDICS-LIMERICK
Manufacturer StreetRAHEEN BUSINESS PARK
Manufacturer CityLIMERICK NA
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIRECTINJECT ON DEMAND HA CEMENT
Generic NameIMPLANT
Product CodeGXP
Date Received2016-06-09
Catalog Number79-45905
Lot NumberDI15322
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOPAEDICS-LIMERICK
Manufacturer AddressRAHEEN BUSINESS PARK LIMERICK NA NA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-06-09

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