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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50 Back to Search Results
Model Number 01.26.50MB
Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 03/08/2022
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 10 march 2022: lot 130545: (b)(4) items manufactured and released on 03-june-2013. Expiration date: 2018-04-30. No anomalies found related to the problem. To date, all the items of the same lot have been sold without any similar reported event since 1-1-2018.
 
Event Description
At 7 years and 11 months after primary, revision surgery because the position of the cup was bad. The reason of this malpositioning is unknown. Acetabular shell revised successfully.
 
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Brand NameCUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50
Type of DeviceACETABULAR SHELL
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 Key14040038
MDR Text Key288772243
Report Number3005180920-2022-00236
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2018
Device Model Number01.26.50MB
Device Catalogue Number01.26.50MB
Device Lot Number130545
Was Device Available for Evaluation? No
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/03/2013
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: 04/07/2022 Patient Sequence Number: 1
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