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U.S. Department of Health and Human Services

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

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 48 Back to Search Results
Model Number 01.26.48MB
Device Problem Failure to Align (2522)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/27/2020
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 16 november 2020: lot 178346: (b)(4) items manufactured and released on 14-mar-2018. Expiration date: 2023-03-04. 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. Other device involved in the event: ball heads: mectacer 01. 29. 201 biolox delta ceramic ball head 12/14 ø 28 size s -3. 5 lot. 176358 (k112115). Batch review performed on 16 november 2020: lot 176358: (b)(4) items manufactured and released on 08-mar-2018. Expiration date: 2023-02-25. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event Description
There was a joint geometry issue. Malalignment of the cup and leg length was a bit short. Cup needed to be revised to correct the joint geometry. Cup, liner and head were revised successfully 1 year and 8 months after primary.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL 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 Key10928295
MDR Text Key218980664
Report Number3005180920-2020-00859
Device Sequence Number1
Product Code MEH
Combination Product (y/n)Y
Reporter Country CodeUK
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 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number01.26.48MB
Device Catalogue Number01.26.48MB
Device Lot Number178346
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2018
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: 12/01/2020 Patient Sequence Number: 1
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