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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 48; CEMENTLESS ACETABULAR SHELL
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MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 48; CEMENTLESS ACETABULAR SHELL Back to Search Results
Catalog Number 01.26.48MB
Health Effect - Clinical Codes Pain (1994); Joint Disorder (2373)
Date of Event 06/15/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 july 2017.Lot 157611: (b)(4) items manufactured and released on 19 april 2016.Expiration date: 2021-04-05.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 complained of pain.The surgeon revised the cup, head, and liner.He also determinated that the cause of pain was due to the cup being too lateral.The surgery was completed successfully.X-rays and explants are not available.
 
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Brand Name
VERSAFITCUP ACETABULAR SHELL Ø 48
Common Device Name
CEMENTLESS ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6714030
Report Number3005180920-2017-00380
Device Sequence Number590285
Product Code MEH
UDI-Device Identifier07630030808036
UDI-Public07630030808036
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K083116
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/14/2017
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 Date04/05/2021
Device Catalogue Number01.26.48MB
Device Lot Number157611
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/15/2017
Initial Report FDA Received Date07/14/2017
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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