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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50; CEMENTLESS ACETABULAR SHELL
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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50; CEMENTLESS ACETABULAR SHELL Back to Search Results
Catalog Number 01.26.45.1150
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/05/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 184694: (b)(4) items manufactured and released on 19-sep-2018.Expiration date: 2023-09-11.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.
 
Event or Problem Description
Patient had symptoms of hip pain 6 weeks after the primary surgery.X-rays showed the stem loosening and the biopsy showed signs of infection.All components were removed, 3 months after primary.We do not have any detail concerning the head and liner, the stem was from a competitor company.
 
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Brand Name
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
Common Device Name
CEMENTLESS ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8482791
Report Number3005180920-2019-00234
Device Sequence Number1432210
Product Code LZO
UDI-Device Identifier07630030807886
UDI-Public07630030807886
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K122911
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/04/2019
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 Expiration Date09/11/2023
Device Catalogue Number01.26.45.1150
Device Lot Number184694
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/05/2019
Initial Report FDA Received Date04/04/2019
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;
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