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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 No Code Available (3191)
Date of Event 09/11/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 october 2018.Lot 145347: 100 items manufactured and released on 09 october 2014.Expiration date: 2022-09-24.No anomalies found related to the problem.To date, 99 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 3 years and a half after primary the surgeon revised the patient hip for cup impingement with psoas muscle.Cup, liner and head swap.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 Key7938084
Report Number3005180920-2018-00759
Device Sequence Number2269560
Product Code LZO
UDI-Device Identifier07630030807756
UDI-Public07630030807756
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K103352
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
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 Number01.26.45.0048
Device Lot Number145347
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/07/2018
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 Age54 YR
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