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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT CUP; HIP IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT CUP; HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problems Detachment Of Device Component (1104); Failure to Osseointegrate (1863)
Patient Problems Injury (2348); Osteolysis (2377)
Event Date 10/01/2015
Event Type  Injury  
Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
The pharmacist and risk manager at the hospital reported the following event to (b)(6): "transverse fracture of the cup facing a trident + abg ii modular acetabular devices.Acute cup loosening.Revision surgery.Synovitis by debris and metallic particles: gluteal infiltration.Cup osteolysis = responsible for embrittlement fracture.Complete change of the total hip prosthesis on (b)(6) 2015.".
 
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Brand Name
UNKNOWN TRIDENT CUP
Type of Device
HIP 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
sandra spokane
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5238544
MDR Text Key31680150
Report Number0002249697-2015-03946
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 11/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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