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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 2 STD CEMENTLESS FEMORAL STEM

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MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 2 STD CEMENTLESS FEMORAL STEM Back to Search Results
Catalog Number 01.18.132
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Pain (1994); Joint Disorder (2373)
Event Date 05/15/2017
Event Type  Injury  
Manufacturer Narrative

Additional information received on 18 may 2017 and includes: the surgery has been rescheduled for (b)(6) 2017. The surgeon plans to revise the stem, head and liner. Additional information received on 26 may 2017 and includes: the revision surgery was completed successfully. Batch review performed on 12 june 2017. (b)(4). On 12 june 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial revision of cementless tha after 4 years. The information available does not allow any conclusion to be drawn. One very low quality x-ray picture is supplied and shows a clear distal pedestal, along with radiolucencies along the stem. These findings are compatible with a painful loose stem, but the causes cannot be determined.

 
Event Description

The patient came in complaining of pain. The surgeon determined that the stem was loose. The surgeon plans to revise the stem, head and liner.

 
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Brand NameAMISTEM H, HA COATED STEM SIZE 2 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 Key6640052
MDR Text Key77536401
Report Number3005180920-2017-00301
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
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 06/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2017
Device Catalogue Number01.18.132
Device LOT Number125395
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/18/2013
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: 06/14/2017 Patient Sequence Number: 1
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