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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 0; HIP UNCEMENTED STEM
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MEDACTA INTERNATIONAL SA AMISTEM H HA COATED STD STEM SIZE 0; HIP UNCEMENTED STEM Back to Search Results
Model Number 01.18.130
Date of Event 03/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 march 2021: lot 146850: (b)(4) items manufactured and released on 08-jan-2015.Expiration date: 2019-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported on this lot since 2017.Clinical evaluation: 5 years after primary tha the patient reports with thigh pain.The radiographic image shows a diffused radiolucency around the stem, particularly in the proximal area, suggesting a radiographically loose stem, no mention of infection was recorded.We must therefore conclude that this case is due to aspetic loosening, which is a potential complication of hip arthroplasty, and causes remain often unknown.
 
Event or Problem Description
Revision surgery performed due to stem loosening 4 years 11 months after the primary.The surgeon revised the stem and head.The surgery was completed successfully.
 
Additional Manufacturer Narrative
Preliminary investigation performed by medacta hip r&d project manager: looking at the image attached to the complaint it is evaluated that the whole ha coating on the stem body has been correctly absorbed by the patient bone.Some signs and scratches are present on the neck part, probably due to the revision surgery.It is not possible to determine the root cause of reported loosening.
 
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Brand Name
AMISTEM H HA COATED STD STEM SIZE 0
Common Device Name
HIP UNCEMENTED STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11581254
Report Number3005180920-2021-00242
Device Sequence Number14492521
Product Code LZO
UDI-Device Identifier07630030804069
UDI-Public07630030804069
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 06/22/2021
1 Device 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 Date11/30/2019
Device Model Number01.18.130
Device Catalogue Number01.18.130
Device Lot Number146850
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/01/2021
Supplement Date Received by Manufacturer03/01/2021
Initial Report FDA Received Date03/29/2021
Supplement Report FDA Received Date06/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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