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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; IMPLANT Back to Search Results
Catalog Number 625-0T-32E
Device Problems Fracture (1260); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/20/2015
Event Type  Injury  
Event Description
It was reported that the patient was revised because the liner fractured.The cup and head were revised as well.The ceramic liner was cracked and even fragmented into pieces.
 
Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.
 
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Brand Name
TRIDENT ALUMINA INSERT
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
sandra spokane
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4702717
MDR Text Key5719527
Report Number0002249697-2015-01233
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number625-0T-32E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2015
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; Other; Required Intervention;
Patient Age25 YR
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