UNKNOWN_JOINT REPLACEMENT_PRODUCT UNK_JR

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 2020-03-31 for UNKNOWN_JOINT REPLACEMENT_PRODUCT UNK_JR manufactured by Stryker Orthopaedics-mahwah.

Event Text Entries

[188215675] 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


[188215676] This pi is for patient 1 of 4, whose poly insert dislocated from the metal liner. As reported by surgeon to r&d: "four (revisions of mdm liners/ adm shells and inserts due to dislocation) that i know of, two with imaging... " imaging for one patient was attached showing a poly insert attached to a femoral head/ stem, with a notch in the stem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002249697-2020-00656
MDR Report Key9904326
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-04-26
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-31
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-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 NameUNKNOWN_JOINT REPLACEMENT_PRODUCT
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Product CodeLPH
Date Received2020-03-31
Catalog NumberUNK_JR
Lot NumberUNKNOWN
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 2020-03-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.