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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LEGEND. V40(TM) FEMORAL STEM HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH LEGEND. V40(TM) FEMORAL STEM HIP IMPLANT Back to Search Results
Catalog Number 4401-0-401
Device Problems Break (1069); Fracture (1260)
Patient Problem Injury (2348)
Event Date 09/05/2018
Event Type  Injury  
Manufacturer Narrative
The event involves a device that is not cleared for sale in the u. S. , but similar device is commercially available in the u. S. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Device not available.
 
Event Description
Hospital representative reported the following event : "spontaneous rupture (without any notion of trauma) of a ceramic total hip replacement feed. ".
 
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Brand NameLEGEND. V40(TM) FEMORAL STEM
Type of DeviceHIP 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
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8203962
MDR Text Key131647166
Report Number0002249697-2018-04162
Device Sequence Number1
Product Code KWA
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,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number4401-0-401
Device Lot NumberGX297569
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
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: 12/28/2018 Patient Sequence Number: 1
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