SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM 2051-2052

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 2015-08-13 for SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM 2051-2052 manufactured by Stryker Orthopaedics-mahwah.

Event Text Entries

[22854099] A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[22854100] It was reported that the liner ring loosened and broke. Visible on xray.
Patient Sequence No: 1, Text Type: D, B5


[30548819] An event regarding crack/fracture involving an omnifit liner was reported. Conclusion: the event was reported for a fractured liner, no allegation of failure was made against the shell. Based on the provided information, the product reported in this investigation did not contribute to the event. No further investigation is required at this time. If additional information and/or device becomes available this record will be reopened.
Patient Sequence No: 1, Text Type: N, H10


[30548820] It was reported that the liner ring loosened and broke. Visible on xray.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002249697-2015-02624
MDR Report Key5000274
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2015-08-13
Date of Report2015-07-14
Date of Event2015-07-14
Date Mfgr Received2015-09-10
Date Added to Maude2015-08-13
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. WILLIAM HANNA
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 NameSECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM
Generic NameIMPLANT
Product CodeJDK
Date Received2015-08-13
Catalog Number2051-2052
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
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 2015-08-13

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