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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 5; HIP CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 5; HIP CEMENTLESS STEM Back to Search Results
Model Number 01.18.135
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 06/18/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30.06.2021: lot 160738: (b)(4) items manufactured and released on 18-may-2016.Expiration date: 2021-05-02.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 since 2017.
 
Event or Problem Description
4 years and 3 months after the primary surgery the patient came in due to a loose stem.The cause of the loose stem is unknown.The surgeon revised the stem and head.
 
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Brand Name
STEM: AMISTEM H HA COATED STD STEM SIZE 5
Common Device Name
HIP CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12143121
Report Number3005180920-2021-00574
Device Sequence Number11986512
Product Code LZO
UDI-Device Identifier07630030804113
UDI-Public07630030804113
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
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
Report Date (Section B) 07/09/2021
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 Date05/02/2021
Device Model Number01.18.135
Device Catalogue Number01.18.135
Device Lot Number160738
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/18/2021
Initial Report FDA Received Date07/09/2021
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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