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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40(TM). ALUMINA FEMORAL HEAD 28MM DIA. V40 TAPER HIP IMPLAINT

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STRYKER ORTHOPAEDICS-MAHWAH V40(TM). ALUMINA FEMORAL HEAD 28MM DIA. V40 TAPER HIP IMPLAINT Back to Search Results
Catalog Number 63640228
Device Problem Mechanical Problem
Event Date 05/29/2002
Event Type  Injury  
Manufacturer Narrative

Additional information has been requested and if received will be provided in a supplemental report.

 
Event Description

As per operative report, patient's left hip was revised due to dislocating.

 
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Brand NameV40(TM). ALUMINA FEMORAL HEAD 28MM DIA. V40 TAPER
Type of DeviceHIP IMPLAINT
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
keyla colon
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key7542643
Report Number0002249697-2018-01576
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number63640228
Device LOT NumberGZ582029
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 Received04/27/2018
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: 05/24/2018 Patient Sequence Number: 1
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