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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL CC Ø 48
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MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL CC Ø 48 Back to Search Results
Catalog Number 01.26.48MB
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 09/05/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 october 2018; lot 172585: (b)(4) items manufactured and released on 22 september 2009.Expiration date: 2014-08-31; no anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
Revision surgery performed due to cup loosening 8 years and 7 months.The surgeon revised the cup, head and liner.
 
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Brand Name
VERSAFITCUP ACETABULAR SHELL CC Ø 48
Common Device Name
ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7938069
Report Number3005180920-2018-00752
Device Sequence Number11266271
Product Code MEH
UDI-Device Identifier07630030808036
UDI-Public07630030808036
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K083116
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/05/2018
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 Date09/24/2022
Device Catalogue Number01.26.48MB
Device Lot Number091851
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/05/2018
Initial Report FDA Received Date10/05/2018
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 Age53 YR
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