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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H AMISTEM-H PROXIMAL COATING LAT STEM SIZE 2; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H AMISTEM-H PROXIMAL COATING LAT STEM SIZE 2; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.182
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/30/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 november 2019: lot 173533: 42 items manufactured and released on 22-nov-2017.Expiration date: 2022-11-13.No anomalies found related to the problem.To date, 38 items of the same lot have been already sold with one similar reported event.
 
Event or Problem Description
Revision surgery performed 1 year and 7 months after the primary due to instability caused by a loose stem.The cause of the loose stem is unknown.The surgeon revised the stem and liner and the surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM H AMISTEM-H PROXIMAL COATING LAT STEM SIZE 2
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9393524
Report Number3005180920-2019-00997
Device Sequence Number1954177
Product Code LZO
UDI-Device Identifier07630030804472
UDI-Public07630030804472
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K161635
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) 12/02/2019
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 Date11/13/2022
Device Catalogue Number01.18.182
Device Lot Number173533
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2019
Initial Report FDA Received Date12/02/2019
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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