TRIDENT ALUMINA INSERT 625-0T-28D

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 2020-03-19 for TRIDENT ALUMINA INSERT 625-0T-28D manufactured by Stryker Orthopaedics-mahwah.

Event Text Entries

[185495831] 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.
Patient Sequence No: 1, Text Type: N, H10


[185495832] While conversing with a surgeon regarding a patient with an alleged knee construct with squeaking, the surgeon sent the following message: "just received the implant stickers of the right hip replacement of the patient with the squeaking. She does have a ceramic on ceramic hip replacement which could be the source of the squeaking. " implant stickers of the hip, implanted in 2005, are provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002249697-2020-00560
MDR Report Key9857600
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-03-19
Date of Report2020-03-19
Date of Event2020-02-20
Date Mfgr Received2020-02-20
Device Manufacturer Date2005-04-25
Date Added to Maude2020-03-19
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. COLLIN NEITZEL
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER ORTHOPAEDICS-CORK
Manufacturer StreetIDA INDUSTRIAL ESTATE
Manufacturer CityCARRIGTWOHILL NA
Manufacturer CountryIE
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRIDENT ALUMINA INSERT
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
Product CodeMRA
Date Received2020-03-19
Model Number625-0T-28D
Catalog Number625-0T-28D
Lot Number13286001
Device Expiration Date2010-04-30
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. Other 2020-03-19

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