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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
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MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54 Back to Search Results
Catalog Number 01.26.45.0054
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 05/04/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 may 2018; lot 170935:(b)(4) items manufactured and released on 06 july 2017.Expiration date: 2022-06-25; 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
Revision surgery due to acetabular shell loosening 3 months after primary.The surgeon revised the cup, liner and femoral head.
 
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Brand Name
VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
Common Device Name
ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7560666
Report Number3005180920-2018-00396
Device Sequence Number1261536
Product Code LZO
UDI-Device Identifier07630030807787
UDI-Public07630030807787
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K103352
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/01/2018
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 Date06/25/2022
Device Catalogue Number01.26.45.0054
Device Lot Number170935
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 05/04/2018
Initial Report FDA Received Date06/01/2018
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;
Patient Age65 YR
Patient Weight70
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