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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 STEM SIZE 3; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 3; CEMENTLESS HIP STEM Back to Search Results
Model Number 01.18.143
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code Pain (1994)
Date of Event 03/08/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021 lot 132152: 30 items manufactured and released on (b)(6) 2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2017.
 
Event or Problem Description
The patient came in reporting pain due to a loose stem 5 years and 9 months after the primary surgery.The surgeon revised the stem and head with competitor implants and revised the medacta liner with a medacta liner.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM H HA COATED LAT STEM SIZE 3
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11626052
Report Number3005180920-2021-00268
Device Sequence Number3499245
Product Code LZO
UDI-Device Identifier07630030804199
UDI-Public07630030804199
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/07/2021
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 Date06/30/2018
Device Model Number01.18.143
Device Catalogue Number01.18.143
Device Lot Number132152
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/08/2021
Initial Report FDA Received Date04/07/2021
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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