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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 48 Back to Search Results
Catalog Number 01.26.48MB
Device Problem Unintended Movement (3026)
Patient Problem Pain (1994)
Event Date 09/24/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 04-oct-2019: lot 155352: 50 items manufactured and released on 22-jun-2016. Expiration date: 11. Jan. 2021. No anomalies found related to the problem. To date, all items of the same lot have been already sold without any other similar reported event. Clinical evaluation performed by medical affairs department: revision surgery performed 3, 5 years after cementless double-mobility total hip arthroplasty. In the radiographic image provided the cup looks horizontal and protruded in the pelvis. From this single pre-revision x-ray it is not possible to determine the primary position of the cup. Furthermore, no information concerning patient age and bone quality is available. The reason of this event cannot be determined.
 
Event Description
The patient came in complaining of pain and the cause of the pain was a shifted cup post-implantation (after 3 years and 5 months from the primary surgery), the acetabulum wall is not fractured. The surgeon revised the cup and liner and the surgery was completed successfully.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL Ø 48
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 Key9233157
MDR Text Key176281107
Report Number3005180920-2019-00893
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/11/2021
Device Catalogue Number01.26.48MB
Device Lot Number155352
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2016
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: 10/24/2019 Patient Sequence Number: 1
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