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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL, SA AMISTEM H CEMENTLESS STEM SIZE 3 LAT; FEMORAL CEMENTLESS STEM
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MEDACTA INTERNATIONAL, SA AMISTEM H CEMENTLESS STEM SIZE 3 LAT; FEMORAL CEMENTLESS STEM Back to Search Results
Device Problem Material Deformation (2976)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
Imp ref # (b)(4).
 
Manufacturer Narrative
Document review: amistem h cementless stem size 3 lat: ref.01.18.143 / lot 136200 ((b)(4) devices produced): all parameters were found to be in accordance with the specs valid at the time of mfg, including washing and sterilization procedures.(b)(4) stems of the lot have been already sold without any similar event reported.From the data collected, there are no evidences that the event is device related.
 
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Brand Name
AMISTEM H CEMENTLESS STEM SIZE 3 LAT
Type of Device
FEMORAL CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL, SA
strada regina 6874
castel san pietro
SZ 
Manufacturer (Section G)
MEDACTA INTERNATIONAL, SA
strada regina 6874
castel san pietro 6874
SZ   6874
Manufacturer Contact
adam gross
1556 w carrol ave
chicago, IL 60607
3128782381
MDR Report Key4297182
MDR Text Key5268708
Report Number3005180920-2014-00166
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K093944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Type of Report Initial
Report Date 11/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/26/2014
Distributor Facility Aware Date11/12/2014
Device Age7 MO
Event Location Hospital
Date Report to Manufacturer11/26/2014
Date Manufacturer Received10/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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