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U.S. Department of Health and Human Services

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

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 50 Back to Search Results
Catalog Number 01.26.50MB
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Joint Disorder (2373)
Event Date 09/24/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 1 october 2019: lot 092013: (b)(4) items manufactured and released on 29 october 2009. Expiration date: 2014-08-31. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event Description
Revision surgery performed 9 years and 7 months after the primary due to pain caused by a loose cup. The cause of the loose cup is unknown. The surgeon revised the cup, head, and insert successfully.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL CC 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 Key9233161
MDR Text Key170773030
Report Number3005180920-2019-00891
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 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 Date08/31/2014
Device Catalogue Number01.26.50MB
Device Lot Number092013
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 Manufactured10/29/2009
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: 10/24/2019 Patient Sequence Number: 1
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