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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 ACETABULAR CUP

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 48 ACETABULAR CUP Back to Search Results
Catalog Number 01.26.48MB
Device Problem Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 11/30/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 4 december 2019. Lot 165684: (b)(4) items manufactured and released on 25-jan-2017 expiration date: 01/10/2022. 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 events. Additional implant involved: stem: minimax 01. 13. 102r cementless anatomical stem right size 2 (k170845) lot. 172015. Batch review performed on 4 december 2019 lot 172015: (b)(4) items manufactured and released on 31-aug-2017 expiration date: 18/08/2022. 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 events. Clinical evaluation performed by medical affairs manager hip revision surgery performed 1 year and 8 months after cementless double mobility total hip arthroplasty in a (b)(6) year old woman. Radiographic image provided shows suboptimal cup position. The reason of this choice is unknown: bone morphology or patient anatomy may be one reason but this cannot be confirmed on the basis of a single anteroposterior x-ray. There is no reason to suspect a faulty device.
 
Event Description
Revision surgery performed 1 year and 9 months after the primary due to impingement (the cup with the stem or the lesser trochanter with the pelvis). The cup was anteverted (the cause is unknown). The surgeon revised the head and liner. Infection not present.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL Ø 48
Type of DeviceACETABULAR CUP
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 Key9525226
MDR Text Key188116305
Report Number3005180920-2019-01084
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
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 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/10/2022
Device Catalogue Number01.26.48MB
Device Lot Number165684
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/25/2017
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: 12/27/2019 Patient Sequence Number: 1
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