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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STELKAST INC. EXP ACETABULAR SHELL AND LINER 36MM COCR FEMORAL HEAD

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STELKAST INC. EXP ACETABULAR SHELL AND LINER 36MM COCR FEMORAL HEAD Back to Search Results
Model Number SC3261-36MM -3.5
Device Problem Insufficient Information (3190)
Patient Problem Hip Fracture (2349)
Event Date 01/13/2017
Event Type  Injury  
Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned. Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.
 
Event Description
Patient presented for surgery due to fractured femur. Thirty six millimeter (36mm) femoral head was revised during the surgery.
 
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Brand NameEXP ACETABULAR SHELL AND LINER
Type of Device36MM COCR FEMORAL HEAD
Manufacturer (Section D)
STELKAST INC.
200 hidden valley road
mcmurray PA 15317
Manufacturer (Section G)
STELKAST INC.
200 hidden valley road
mcmurray PA 15317
Manufacturer Contact
john reyher
200 hidden valley road
mcmurray, PA 15317
7249416368
MDR Report Key6264507
MDR Text Key65297251
Report Number2530191-2017-00016
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K094035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 01/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC3261-36MM -3.5
Device Lot Number34803251031
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2015
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: 01/19/2017 Patient Sequence Number: 1
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