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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 7; CEMENTED HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 7; CEMENTED HIP STEM Back to Search Results
Catalog Number 01.18.157
Health Effect - Clinical Code Pain (1994)
Date of Event 10/04/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 october 2018.Lot 175353: (b)(4) items manufactured and released on 12 october 2017.Expiration date: 2022-10-03.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
Patient came in complaining of pain, 1 year after primary surgery.The surgeon determined that the stem had subsided.The cause of the subsidence is unknown.The surgeon revised the stem and head.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM C CEMENTED STD STEM SIZE 7
Common Device Name
CEMENTED HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8019257
Report Number3005180920-2018-00853
Device Sequence Number16554117
Product Code LZO
UDI-Device Identifier07630030804328
UDI-Public07630030804328
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103189
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/30/2018
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 Date10/03/2022
Device Catalogue Number01.18.157
Device Lot Number175353
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/04/2018
Initial Report FDA Received Date10/30/2018
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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