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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; IMPLANT Back to Search Results
Catalog Number 502-11-52E
Device Problems Device Slipped (1584); Device Inoperable (1663)
Patient Problem Fall (1848)
Event Date 01/16/2014
Event Type  Injury  
Event Description
(b)(6) 2014: the tha was done for oa.(b)(6) 2014: the loosening of the trident cup was occured because the patient fell.It was noted by the doctor that the cup was not completely covered acetabular because the cover of the back wall of the acetabular is slight.It might have needed a screw fixed.
 
Event Description
(b)(6) 2014: the tha was done for oa.(b)(6) 2014: the loosening of the trident cup was occured because the patient fell.It was noted by the doctor that the cup was not completely covered acetabular because the cover of the back wall of the acetabular is slight.It might have needed a screw fixed.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
An event regarding loosening involving a trident shell was reported.The event was not confirmed.The shell was returned assembled with the mdm liner.The shell has sparse areas of fibrous on-growth in the coated surface.Review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Review indicated there have been no other events for the reported lot.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, and x-rays are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.Product surveillance will continue to monitor for trends.
 
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Brand Name
TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
niku kasmai
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3608823
MDR Text Key4090392
Report Number0002249697-2014-00324
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K013676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2018
Device Catalogue Number502-11-52E
Device Lot Number45318501
Other Device ID NumberSTER. LOT 1309PCM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/23/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/23/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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