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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 50; CEMENTLESS ACETABULAR SHELL
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MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 50; CEMENTLESS ACETABULAR SHELL Back to Search Results
Catalog Number 01.26.50MB
Health Effect - Clinical Codes Pain (1994); Joint Disorder (2373)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 october 2017.Lot 122511: (b)(4) items manufactured and released on 04 september 2012.Expiration date: 2017-08-31.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.The surgeon determined the cup was loose.The loosening occurred over time.The cup, liner and head were revised as planned on (b)(6) 2017.The surgery was completed successfully.
 
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Brand Name
VERSAFITCUP ACETABULAR SHELL Ø 50
Common Device Name
CEMENTLESS ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6921509
Report Number3005180920-2017-00553
Device Sequence Number13618573
Product Code MEH
UDI-Device Identifier07630030808067
UDI-Public07630030808067
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 Year2013
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/06/2017
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 Date08/31/2017
Device Catalogue Number01.26.50MB
Device Lot Number122511
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/06/2017
Initial Report FDA Received Date10/06/2017
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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