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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 STEMSIZE 0; CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEMSIZE 0; CEMENTLESS STEM Back to Search Results
Catalog Number 01.18.140
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 10/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 5 november 2019.Lot 163105: 35 items manufactured and released on 12-aug-2016.Expiration date: 2021-07-24.No anomalies found related to the problem.To date, 15 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery preformed 1 year and 5 months after the primary due to instability caused by a loose stem.The patient had poor bone quality.The surgeon revised the head, stem, and liner and the surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM H HA COATED LAT STEMSIZE 0
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9361086
Report Number3005180920-2019-00976
Device Sequence Number14061408
Product Code LZO
UDI-Device Identifier07630030804168
UDI-Public07630030804168
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121011
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) 11/22/2019
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 Number01.18.140
Device Lot Number163105
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/24/2019
Initial Report FDA Received Date11/22/2019
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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