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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ELBOW STEM UNKNOWN ELBOW IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ELBOW STEM UNKNOWN ELBOW IMPLANT Back to Search Results
Catalog Number UNK_REC
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 02/16/2016
Event Type  Injury  
Manufacturer Narrative
An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to the manufacturer.
 
Event Description
As per sales rep, patients stem component is broken and requires revision surgery. Revision will be planned in the upcoming weeks.
 
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Brand NameUNKNOWN ELBOW STEM
Type of DeviceUNKNOWN ELBOW IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5493720
MDR Text Key40115976
Report Number0002249697-2016-00767
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 02/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_REC
Device Lot NumberUNKNOWN
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 Received02/16/2016
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: 03/10/2016 Patient Sequence Number: 1
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