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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 52

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 52 Back to Search Results
Model Number 01.26.45.1152
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Joint Disorder (2373)
Event Date 05/07/2020
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 25 may 2020: lot 082588: (b)(4) items manufactured and released on 13-oct-2008. Expiration date: 2013-09-30. 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 since 1-1-2016. Other device involved in the event: stem: quadra-h 01. 12. 034 cementless, ha coated lat stem size 4 lot. 082238 (k082792). Batch review performed on 25 may 2020: lot 082238: (b)(4) items manufactured and released on 14-0ct-2008. Expiration date: 2013-09-30. 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 since 1-1-2016.
 
Event Description
Revision surgery for stem and cup loosening about 11 years after primary surgery. Radiolucency was present without a mechanical cause. No infection detected.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL 52
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
castel san pietro, 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key10137533
MDR Text Key195018802
Report Number3005180920-2020-00322
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeSZ
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,Followup
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2013
Device Model Number01.26.45.1152
Device Catalogue Number01.26.52MB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2008
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: 06/10/2020 Patient Sequence Number: 1
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