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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number 502-01-56F
Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)
Patient Problems Injury (2348); Inadequate Osseointegration (2646)
Event Date 01/05/2017
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Additional information has been requested. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Revision left total hip replacement for aseptic loosening.
 
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Brand NameTRIDENT HEMISPHERICAL CLUSTER 56MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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
sarah smelko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6280518
MDR Text Key65849630
Report Number0002249697-2017-00345
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 01/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number502-01-56F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2017
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 Treatment Data
Date Received: 01/26/2017 Patient Sequence Number: 1
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