PINN BANTAM W/GRIPTION 46MM 1217-30-046 121730046

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for PINN BANTAM W/GRIPTION 46MM 1217-30-046 121730046 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[186004486] (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[186004487] It was reported that the cup was implanted on (b)(6) 2013. The liner and head were implanted on (b)(6) 2019. Yesterday we removed the cup, head, and liner. The head and liner looked perfect but the shell had a hole worn all the way through. The hole was between 1/2? -3/4? In size. They weren't able to remove the stem so we implanted a bipolar head instead of using a prostalac stem for a stage 1 revision. Doi: (b)(6) 2013, (cup). Doi: (b)(6) 2019, (liner and head). Dor: (b)(6) 2020, affected site: unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09606
MDR Report Key9899234
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-13
Date of Event2020-03-13
Date Mfgr Received2020-03-13
Device Manufacturer Date2013-08-16
Date Added to Maude2020-03-30
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 ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS INC US
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePINN BANTAM W/GRIPTION 46MM
Generic NamePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Product CodeLPH
Date Received2020-03-30
Model Number1217-30-046
Catalog Number121730046
Lot Number415171
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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