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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 50
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MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50 Back to Search Results
Catalog Number 01.26.45.0050
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2018; lot 175386: (b)(4) items manufactured and released on 05 december 2017.Expiration date: 2022-11-22; 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 cup mobilization 4 months after the primary.The surgeon revised cup, ball head and liner.
 
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Brand Name
VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50
Common Device Name
ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7677486
Report Number3005180920-2018-00490
Device Sequence Number13650411
Product Code LZO
UDI-Device Identifier07630030807763
UDI-Public07630030807763
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 Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/11/2018
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 Date11/22/2022
Device Catalogue Number01.26.45.0050
Device Lot Number175386
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/12/2018
Initial Report FDA Received Date07/11/2018
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 Age67 YR
Patient Weight91
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