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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1; CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1; CEMENTLESS STEM Back to Search Results
Catalog Number 01.18.401
Health Effect - Clinical Code Pain (1994)
Date of Event 12/07/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-dic-2020 lot 1900061: (b)(4) items manufactured and released on 06-may-2019.Expiration date: 2024-04-23.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in reporting pain due to a subsided stem, 1 year 4 months after the primary.The cause of the subsided stem is unknown.The surgeon revised the amistem-p std.#1 with a sms solid stem std #10 and revised the 32mm biolox delta head s with a 32mm biolox delta head s.
 
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Brand Name
STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11086056
Report Number3005180920-2020-00970
Device Sequence Number19779805
Product Code LZO
UDI-Device Identifier07630040720007
UDI-Public07630040720007
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K173794
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/29/2020
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 Date04/23/2024
Device Catalogue Number01.18.401
Device Lot Number1900061
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/07/2020
Initial Report FDA Received Date12/29/2020
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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