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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28 HIP SHELL LINER

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MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28 HIP SHELL LINER Back to Search Results
Model Number 01.26.2850MHC
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
The involved lot and devices are unknown. We don't have and won't have the revision surgery confirmation and results.
 
Event Description
Revision surgery performed about 1 month after the primary surgery due to infection. Liner and head were planned to be revised, but it is not confirmed and more details of the revision will not be available. The outcome of the revision surgery is unknown, the same as the revision date. This information will not be available.
 
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Brand NameVERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28
Type of DeviceHIP SHELL 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 Key10716921
MDR Text Key212446087
Report Number3005180920-2020-00721
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeGM
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 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number01.26.2850MHC
Device Catalogue Number01.26.2850MHC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2020
Was Device Evaluated by Manufacturer? No
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: 10/22/2020 Patient Sequence Number: 1
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