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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 0; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 0; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.130
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 04/04/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 april 2019: lot 153415: (b)(4) items manufactured and released on 18-nov-2015.Expiration date: 2020-10-31.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
Revision surgery after 11 months from the primary due to pain.The surgeon confirmed the stem was loose distally but was well fixed proximally and he was unable to remove the stem.The surgeon chose to revise the head and place biocomposite beads around the stem to aide in bone growth.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM H HA COATED STD STEM SIZE 0
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8573538
Report Number3005180920-2019-00343
Device Sequence Number19354545
Product Code LZO
UDI-Device Identifier07630030804069
UDI-Public07630030804069
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/02/2019
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 Expiration Date10/31/2020
Device Catalogue Number01.18.130
Device Lot Number153415
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/04/2019
Initial Report FDA Received Date05/02/2019
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;
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