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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED HA COATED STEM SIZE 3 LAT CEMENTLESS FEMORAL STEM

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MEDACTA INTERNATIONAL SA AMISTEM COLLARED HA COATED STEM SIZE 3 LAT CEMENTLESS FEMORAL STEM Back to Search Results
Catalog Number 01.18.243
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Pain (1994); Joint Disorder (2373)
Event Date 06/19/2017
Event Type  Injury  
Manufacturer Narrative

On 17 july 2017 the medical affairs director performed a clinical evaluation and commented as follows: femoral stem loosening in cementless tha less than 1 year after primary. No contact or osseointegration is visible from the pre-revision x-rays. According to report, the patient's bone quality was deemed poor, a known and reported partial contraindication to a cementless implant. Signs are radiographically visible that may be consequent to a fracture fixation implant, this may have contributed to poor bone quality, in spite of young age of the patient. We see no reason to ascribe this failure to a faulty device. Batch review performed on 19july 2017. (b)(4).

 
Event Description

The patient came in complaining of pain. The surgeon determined the stem was loose. The loosening was due to poor bone quality. The surgeon revised the stem, head and liner. The surgery was completed successfully. Explants are not available.

 
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Brand NameAMISTEM COLLARED HA COATED STEM SIZE 3 LAT
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 Key6727727
MDR Text Key80521594
Report Number3005180920-2017-00392
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 07/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number01.18.243
Device LOT Number155255
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 Received06/20/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/15/2016
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: 07/20/2017 Patient Sequence Number: 1
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