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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DM DOUBLE MOBILITY HC LINER Ø 58/28; DOUBLE MOBILITY LINER
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MEDACTA INTERNATIONAL SA MPACT DM DOUBLE MOBILITY HC LINER Ø 58/28; DOUBLE MOBILITY LINER Back to Search Results
Catalog Number 01.26.2858MHC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/09/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 164476: 50 items manufactured and released on (b)(6) 2016.Expiration date: 2021-09-26.No anomalies found related to the problem.To date, 34 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
I&d and liner revision performed 34 days after primary surgery due to signs of infection, the pathogen is unknown.
 
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Brand Name
MPACT DM DOUBLE MOBILITY HC LINER Ø 58/28
Common Device Name
DOUBLE MOBILITY LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8137076
Report Number3005180920-2018-00977
Device Sequence Number11205165
Product Code MEH
UDI-Device Identifier07630030807442
UDI-Public07630030807442
Combination Product (Y/N)N
Initial Reporter StateIL
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 company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/13/2018
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 Date09/26/2021
Device Catalogue Number01.26.2858MHC
Device Lot Number164476
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/09/2018
Initial Report FDA Received Date12/06/2018
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;
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