UNITRAX MODULAR ENDO HEAD 47MM 6942-5-047

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-30 for UNITRAX MODULAR ENDO HEAD 47MM 6942-5-047 manufactured by Stryker Orthopaedics-mahwah.

Event Text Entries

[188215290] It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. The following devices were also listed in this report: unitrax modular endo head 47mm; cat# 6942-5-047; lot # 4p3jhj, unitrax v40 sleeve +0mm (std); cat # 6942-6-065; lot # 75883302, accolade c cs 132 nk; cat # 6058-0435d; lot # ta0p1d. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Patient Sequence No: 1, Text Type: N, H10


[188215291] As noted on a usage sheet for revision of patient's left hip: "reason: possible infection. No other information is available due to sealed electronic medical records. " branch provided the primary and revision usage sheets. A unitrax head and sleeve were revised.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002249697-2020-00630
MDR Report Key9898066
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-10-22
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MARISOL SANTIAGO
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER ORTHOPAEDICS-MAHWAH
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal Code07430
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNITRAX MODULAR ENDO HEAD 47MM
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Product CodeJDI
Date Received2020-03-30
Model Number6942-5-047
Catalog Number6942-5-047
Lot Number4P3JHJ
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOPAEDICS-MAHWAH
Manufacturer Address325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-30

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