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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 60/28

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MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28 Back to Search Results
Catalog Number 01.26.2860MHC
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 12/04/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 09 december 2019: lot 162329: (b)(4) items manufactured and released on 25-jul-2016. Expiration date: 2021-06-29. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event Description
The patient came in due to signs of an infection and the pathogen is unknown. The surgeon performed a washout and poly-swap almost 9 months after primary. The surgery was completed successfully.
 
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Brand NameLINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28
Type of DeviceDOUBLE MOBILITY HC LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key9502120
MDR Text Key185728219
Report Number3005180920-2019-01100
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092265
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/29/2021
Device Catalogue Number01.26.2860MHC
Device Lot Number162329
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2019 Patient Sequence Number: 1
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