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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD

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MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD Back to Search Results
Catalog Number 01.18.133
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 09/15/2015
Event Type  Injury  
Manufacturer Narrative

Batch review performed on 14 october 2015: (b)(4).

 
Event Description

Revision of femoral stem planned for (b)(6) 2015, due to radiolucent lines shown on rx.

 
Manufacturer Narrative

On (b)(6) 2015 it was communicated that the revision surgery was performed on (b)(6) 2015: the stem was explanted and substituted with another one. On (b)(6) 2015 the medical affairs director analyzed the x-ray received on (b)(6) 2015 with the following comments: male patient, young and reportedly very active, femur anatomy dorr-type a. A difficult case in general for long term performance of tha. The stem probably got engaged distally, it looks a little protruding proximally, there are not enough information to assess if the limb was lengthened as it appears, however this is not necessarily a cause for loosening. Apparently, the stem never achieved proximal load transfer, and with a young active patient with solid bone this may lead to subsequent mobilization, as indicated in literature. The root cause for loosening at 2 years cannot be identified with certainty. Additional distal reaming may be of help in these cases, but there is no consensus in the scientific community. On (b)(6) 2015 it was confirmed that the explant will be sent back for analysis. Not yet received.

 
Manufacturer Narrative

On 19 january 2016, the r&d project manager analysed the returned implants and commented as follows: observing the femoral stem no particular sign can be noted, except on the neck: such signs were probably caused during the removal phase. The ha on the surface of the stem is still present, mainly on the proximal part. Very few bones can be noted on the surface of the stem. On the ceramic femoral head some scratches can be seen, probably caused during the removal phase. It is not possible from the inspection of the implants determine the root cause of the event. On 27 january 2016, it was prepared a final report with the information already submitted in the previous reports and here above. On 08 february 2016, the report was sent to the initial reporter and the case was closed.

 
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Brand NameAMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD
Type of DeviceFEMORAL CEMENTLESS 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
91 6966060
MDR Report Key5152713
MDR Text Key28371087
Report Number3005180920-2015-00238
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK093944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device Catalogue Number01.18.133
Device LOT Number134168
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/18/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/28/2013
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: 10/15/2015 Patient Sequence Number: 1
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