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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 Ø 52
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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52 Back to Search Results
Catalog Number 01.26.45.0052
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 10/07/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 october 2019.Lot 181696: 120 items manufactured and released on 09-may-2018.Expiration date: 2023-04-29.No anomalies found related to the problem.To date, 116 items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in complaining of pain due to a loose cup.The cause of the loose cup is unknown.The surgeon revised 2 screws, head, liner and cup almost 1 year and 1 month after primary.The surgery was completed successfully.
 
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Brand Name
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52
Common Device Name
ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9278375
Report Number3005180920-2019-00931
Device Sequence Number2388915
Product Code LZO
UDI-Device Identifier07630030807770
UDI-Public07630030807770
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K103352
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) 11/05/2019
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 Date04/29/2023
Device Catalogue Number01.26.45.0052
Device Lot Number181696
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/07/2019
Initial Report FDA Received Date11/05/2019
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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