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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO 01.26.45.0056 ACETABULAR SHELL CC TRIO Ø 56; CEMENTLESS ACETABULAR SHELL
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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO 01.26.45.0056 ACETABULAR SHELL CC TRIO Ø 56; CEMENTLESS ACETABULAR SHELL Back to Search Results
Catalog Number 01.26.45.0056
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/10/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No information about the involved lot was provided, so the related documentation could not be reviewed.Clinical evaluation performed by medical affairs manager: infection in cementless tha, 1 year after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
 
Event or Problem Description
Revision surgery performed, one year and two months after primary surgery, due to infection with staphiloccocus.
 
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Brand Name
CUP: VERSAFITCUP CC TRIO 01.26.45.0056 ACETABULAR SHELL CC TRIO Ø 56
Common Device Name
CEMENTLESS ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8319904
Report Number3005180920-2019-00043
Device Sequence Number19214223
Product Code LZO
UDI-Device Identifier07630030807794
UDI-Public07630030807794
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K103352
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/08/2019
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 Catalogue Number01.26.45.0056
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/11/2019
Initial Report FDA Received Date02/08/2019
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 Weight75
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