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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 2 CEMENTLESS HIP STEM

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MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 2 CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.142
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Joint Disorder (2373)
Event Date 12/13/2017
Event Type  Injury  
Manufacturer Narrative

Batch review performed on 05 january 2018: lot 153982: (b)(4) items manufactured and released on 09 december 2015. Expiration date: 2020-11-24. No anomalies found related to the issue. To date, (b)(4) items of the same lot have been already sold without any similar reported event.

 
Event Description

The patient complained hip laxity. 1 year and 8 months after primary the surgeon detected a stem subsidence and revised successfully the patient swapping the stem, the head and the liner.

 
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Brand NameAMISTEM H HA COATED LAT STEM SIZE 2
Type of DeviceCEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, 6874
SZ   6874
MDR Report Key7185279
MDR Text Key97056017
Report Number3005180920-2017-00827
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 01/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number01.18.142
Device LOT Number153982
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/13/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/09/2015
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: 01/12/2018 Patient Sequence Number: 1
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