FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S PHA04402

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-23 for FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S PHA04402 manufactured by Microport Orthopedics Inc..

Event Text Entries

[184652516] This event will be updated once the investigation is complete. Trends will be evaluated.
Patient Sequence No: 1, Text Type: N, H10


[184652517] Allegedly, patient was revised due to dislocation. Mpo procotyl implants removed and replaced with mpo dynasty implants. 28mm femoral head removed and changed to 32mm femoral head. The surgeon believes that an error in relocating the hip caused the cup to move. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010536692-2020-00261
MDR Report Key9868205
Report SourceDISTRIBUTOR
Date Received2020-03-23
Date of Report2020-03-23
Date Facility Aware2020-03-02
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-23
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 Street5677 AIRLINE ROAD
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal38002
Manufacturer Phone9018674771
Manufacturer G1MICROPORT ORTHOPEDICS INC.
Manufacturer Street5677 AIRLINE RD.
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal Code38002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S
Generic NameHIP COMPONENT
Product CodeLZO
Date Received2020-03-23
Model NumberPHA04402
Catalog NumberPHA04402
Lot Number1826426
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICROPORT ORTHOPEDICS INC.
Manufacturer Address5677 AIRLINE RD. ARLINGTON TN 38002 US 38002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-23

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