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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 CEMENTLESS HIP SHELL

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 48 CEMENTLESS HIP SHELL Back to Search Results
Catalog Number 01.26.48MB
Device Problem Positioning Problem (3009)
Patient Problem Pain (1994)
Event Date 02/05/2019
Event Type  Injury  
Manufacturer Narrative
Clinical evaluation performed by medical affairs director: partial hip revision surgery (cup, head and liner) occurred 2 years and 4 months after cementless dual mobility total hip arthroplasty. According to the report the reason of pain could be soft tissue impingement but this cannot be confirmed on x-rays images. No other information useful for a clinical investigation has been supplied. Batch review performed on 27 february 2019: lot 160828: (b)(4) items manufactured and released on 25-may-2016. Expiration date: 2021-05-10. No anomalies found related to the problem. To date, all the items of this same lot have been already sold without any similar reported event.
 
Event Description
On january 31, 2019 we were informed about the fact that the surgeon was not pleased with the vertical placement of the cup and consequently would have revised the cup, head and liner on (b)(6) 2019. The revision was performed as planned and was completed successfully. According to the surgeon the pain was caused by the dm cup that was causing impingement of soft tissue.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL Ø 48
Type of DeviceCEMENTLESS HIP SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key8374048
MDR Text Key137271956
Report Number3005180920-2019-00112
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 Non-Healthcare Professional
Type of Report Initial
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/10/2021
Device Catalogue Number01.26.48MB
Device Lot Number160828
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/25/2016
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: 02/27/2019 Patient Sequence Number: 1
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