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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY HC LINER Ø 46/22.2
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MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY HC LINER Ø 46/22.2 Back to Search Results
Catalog Number 01.26.2246MHC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/04/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 july 2018: lot 177523: 72 items manufactured and released on 16 january 2018.Expiration date: 2023-01-01.No anomalies found related to the issue.To date, 39 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 1 month after primary the surgeon revised the patient for a infection case.Liner swap.The surgery was completed successfully.
 
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Brand Name
MPACT DOUBLE MOBILITY HC LINER Ø 46/22.2
Common Device Name
DOUBLE MOBILITY HC LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7726664
Report Number3005180920-2018-00567
Device Sequence Number19058415
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 Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/27/2018
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 Date01/01/2023
Device Catalogue Number01.26.2246MHC
Device Lot Number177523
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/04/2018
Initial Report FDA Received Date07/27/2018
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 Age80 YR
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