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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 Problem Joint Disorder (2373)
Event Date 05/07/2017
Event Type  Injury  
Manufacturer Narrative

On 23 june 2017 the medical affairs performed a clinical evaluation and commented as follows: femoral component revision surgery in a young overweight patient 7 years after primary cementless tha. No pre-revision x-ray is available. According to the report, the reason for revision was stem loosening. Aseptic loosening is a possible, literature described adverse event after tha and causes are often unknown. In this case, reason for failure can't be determined. Batch review performed on 10 july 2017. Lot 110850: (b)(4) items manufactured and released on 05 may 2011. Expiration date: 2016-03-31. No anomalies found related to the problem. To date, all items of the same lot have been already sold without any similar reported event. On 12 july 2017 the r&d project manager performed a preliminary investigation based on the available images and commented as follows: scratches and signs can be noted on both internal and external surfaces of the ceramic head. Scratches can be noted on the neck portion of the stem. The root cause of the event cannot be determined.

 
Event Description

Revision for stem loosing.

 
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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
6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
SZ   6874
MDR Report Key6710266
MDR Text Key79921397
Report Number3005180920-2017-00371
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeSZ
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
Report Date 07/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2016
Device Catalogue Number01.18.132
Device LOT Number110850
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 Received06/13/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/05/2011
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: 07/13/2017 Patient Sequence Number: 1
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