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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 5; CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 5; CEMENTLESS STEM Back to Search Results
Catalog Number 01.18.145
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Pain (1994)
Date of Event 08/27/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager.Partial revision surgery performed 6 years after cementless total hip arthroplasty in a (b)(6) years old man.No information concerning patient health status and level of activity is available.Radiographic images provided show the presence of radiolucent lines in gruen zones 1, 2, 6 and 7 and signs of stress shielding.Aseptic loosening is a possible, literature described mid-term adverse event after cementless tha and causes are often unknown.The reason of this event cannot be determined.
 
Event or Problem Description
On 27-august-2019 we were informed that a revision surgery is planned on (b)(6) almost 6 years after primary surgery, due to stem loosening and pain.
 
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Brand Name
STEM: AMISTEM H HA COATED LAT STEM SIZE 5
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9123271
Report Number3005180920-2019-00797
Device Sequence Number2811621
Product Code LZO
UDI-Device Identifier07630030804212
UDI-Public07630030804212
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number01.18.145
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2019
Initial Report FDA Received Date09/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age58 YR
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