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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 Ø 46/22.2; DOUBLE MOBILITY ACETABULAR LINER HC
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MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 46/22.2; DOUBLE MOBILITY ACETABULAR LINER HC Back to Search Results
Catalog Number 01.26.2246MHC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/26/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 april 2019: lot 187117: (b)(4) items manufactured and released on 08-nov-2018.Expiration date: 2023-10-22.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
1 month after primary revision surgery for infection.The surgeon performed an i&d, revised another company's head with another company's head and revised the liner with a medacta liner.The surgery was completed successfully.
 
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Brand Name
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 46/22.2
Common Device Name
DOUBLE MOBILITY ACETABULAR LINER HC
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8548594
Report Number3005180920-2019-00308
Device Sequence Number13885960
Product Code MEH
UDI-Device Identifier07630030806834
UDI-Public07630030806834
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K092265
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/25/2019
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 Date10/22/2023
Device Catalogue Number01.26.2246MHC
Device Lot Number187117
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/26/2019
Initial Report FDA Received Date04/25/2019
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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