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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 56/28; VERSAFITCUP DM LINER
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MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 56/28; VERSAFITCUP DM LINER Back to Search Results
Model Number 01.26.2856MHC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/03/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2020: lot 1900250: (b)(4) items manufactured and released on 18-mar-2019.Expiration date: 2024-03-04.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
Two months after primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the competitor stem and head with competitor products, and revised the versafitcup dm liner hc 56/28 with a versafitcup dm liner hc 56/28.The surgery was completed successfully.
 
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Brand Name
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 56/28
Common Device Name
VERSAFITCUP DM LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10919853
Report Number3005180920-2020-00856
Device Sequence Number14114528
Product Code MEH
UDI-Device Identifier07630030807411
UDI-Public07630030807411
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K092265
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/30/2020
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 Date03/04/2024
Device Model Number01.26.2856MHC
Device Catalogue Number01.26.2856MHC
Device Lot Number1900250
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/03/2020
Initial Report FDA Received Date11/30/2020
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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