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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 6 STD CEMENTLESS FEMORAL STEM

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MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 6 STD CEMENTLESS FEMORAL STEM Back to Search Results
Catalog Number 01.18.136
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Joint Disorder (2373)
Event Date 07/28/2017
Event Type  Injury  
Manufacturer Narrative

On 18 august 2017 the medical affairs performed a clinical evaluation and commented as follows: partial revision on a cementless primary tha after 1,5 years. The quality of the available x-rays is extremely poor and no real assessment can be made. It appears that the stem is proximally debonded and radiographically loose. Some black shadows, both proximally and distally, are visible, but we cannot determine whether they are visual artefacts or signs of a specific situation. The root cause for this failure cannot be determined with the information at hand. Batch review performed on 22 august 2017. Lot 140016: (b)(4) items manufactured and released on 08 april 2014. Expiration date: 2019-02-28. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event.

 
Event Description

Revision surgery performed due to stem loosening, 1 year and 5 months after primary surgery. The stem was easily removed with the extractor. It seems that the prosthesis never really integrated into the metaphyseal part and the patient has always been painful.

 
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Brand NameAMISTEM H, HA COATED STEM SIZE 6 STD
Type of DeviceCEMENTLESS FEMORAL 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 Key6819962
MDR Text Key83639492
Report Number3005180920-2017-00476
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
Report Date 10/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device Catalogue Number01.18.136
Device LOT Number140016
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/05/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2014
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: 08/25/2017 Patient Sequence Number: 1
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