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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED STD STEM SIZE 6; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA AMISTEM H HA COATED STD STEM SIZE 6; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.136
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/26/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 july 2018; lot 177148: (b)(4) items manufactured and released on 02 march 2018.Expiration date: 2023-02-21; 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 or Problem Description
During a primary hip the femur fractured.It is unknown if the fracture occurred during the trial phase of the final implantation.The surgeon added cables to stabilize the fracture.The surgery was completed successfully.
 
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Brand Name
AMISTEM H HA COATED STD STEM SIZE 6
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7722397
Report Number3005180920-2018-00545
Device Sequence Number13715884
Product Code LZO
UDI-Device Identifier07630030804120
UDI-Public07630030804120
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/26/2018
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 Expiration Date02/21/2023
Device Catalogue Number01.18.136
Device Lot Number177148
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/26/2018
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 Disability;
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