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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 48
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MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48 Back to Search Results
Catalog Number 01.26.45.0048
Health Effect - Clinical Code Bone Fracture(s) (1870)
Date of Event 04/24/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 may 2018; lot 175952: (b)(4) items manufactured and released on 22 january 2018.Expiration date: 2023-01-10; 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
The patient came in complaining of pain 5 days after the primary.The patient had fractured the pelvic wall.The cause of the fracture is unknown, no report of trauma.The surgeon revised the cup, head and liner.The surgery was completed successfully.
 
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Brand Name
VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
Common Device Name
ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7540708
Report Number3005180920-2018-00359
Device Sequence Number2482022
Product Code LZO
UDI-Device Identifier07630030807756
UDI-Public07630030807756
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 Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/24/2018
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 Date01/10/2023
Device Catalogue Number01.26.45.0048
Device Lot Number175952
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 04/24/2018
Initial Report FDA Received Date05/24/2018
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;
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