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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 4; CEMENTED HIP STEM
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MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 4; CEMENTED HIP STEM Back to Search Results
Catalog Number 01.18.154
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 12/01/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 december 2017 lot 155530: (b)(4) items manufactured and released on 30 november 2015.Expiration date: 2018-02-28.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.
 
Event or Problem Description
The patient was revised for a potted stem 3 years after primary [report (b)(4)].The patient came in complaining of pain 1 year later: the stem had subsided.The surgeon revised the stem and head with another company's product.The surgery was completed successfully.
 
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Brand Name
AMISTEM C CEMENTED STD STEM SIZE 4
Common Device Name
CEMENTED HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7153837
Report Number3005180920-2017-00800
Device Sequence Number73067
Product Code LZO
UDI-Device Identifier07630030804298
UDI-Public07630030804298
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K103189
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/29/2017
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 Date02/28/2018
Device Catalogue Number01.18.154
Device Lot Number155530
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/01/2017
Initial Report FDA Received Date12/29/2017
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;
Patient Age53 YR
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