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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 58

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 58 Back to Search Results
Model Number 01.26.58MB
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Joint Disorder (2373)
Event Date 07/14/2020
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 23-jul-2020: lot 092437: (b)(4) items manufactured and released on 18-nov-2009. Expiration date: 31-oct-2014. 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.
 
Event Description
The patient came in reporting pain due to a migrated cup that arose from poor fixation 10 years and 3 months after the primary surgery. The surgeon revised the cup and head and the surgery was completed successfully.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL 58
Type of DeviceACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874, CHE
SZ 6874, CHE
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro 6874, sz
SZ
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874 -CHE
SZ   6874 CHE
MDR Report Key10366569
MDR Text Key201691835
Report Number3005180920-2020-00502
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
Type of Report Initial
Report Date 08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2014
Device Model Number01.26.58MB
Device Catalogue Number01.26.58MB
Device Lot Number092437
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/18/2009
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: 08/05/2020 Patient Sequence Number: 1
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