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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 7; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 7; CEMENTLESS HIP STEM Back to Search Results
Model Number 01.18.137
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Pain (1994)
Date of Event 03/05/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 march 2020: lot 151447: (b)(4) items manufactured and released on 05-aug-2015.Expiration date: 2020-07-11.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 2016.
 
Event or Problem Description
The patient came in, more than 4 years after primary surgery, reporting pain due to a potted stem.The surgeon revised the stem, head, and liner and the surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM H HA COATED STD STEM SIZE 7
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9909440
Report Number3005180920-2020-00212
Device Sequence Number3297023
Product Code LZO
UDI-Device Identifier07630030804137
UDI-Public07630030804137
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/01/2020
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 Date07/11/2020
Device Model Number01.18.137
Device Catalogue Number01.18.137
Device Lot Number151447
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/05/2020
Initial Report FDA Received Date04/01/2020
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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