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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 Material Protrusion/Extrusion (2979)
Patient Problem Hip Fracture (2349)
Event Date 04/15/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 13 may 2019 lot 187024: (b)(4) items manufactured and released on 28-jan-2019. Expiration date: 2024-01-15. 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. Clinical evaluation performed by medical affairs manager: immediate postoperative acetabular cup protrusion through the medial wall after total hip arthroplasty. No information concerning patient age, health status and bone quality is available. This event may be caused by the normal intraoperative bone weakening during acetabular preparation that may have led to the formation of subclinical fissures. There is no reason to suspect a malfunctioning device.
 
Event Description
The patient had a primary hip surgery on (b)(6) 2019. Upon reviewing the post-op x-rays, it was discovered that the cup had protruded through the medial wall during impaction. The surgeon revised, 6 days later, the cup and liner with another company's product and implanted bone chips to promote bone growth in the acetabulum. The surgery was completed 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 Key8607929
MDR Text Key144973384
Report Number3005180920-2019-00370
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 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number01.26.50MB
Device Lot Number187024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/28/2019
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: 05/14/2019 Patient Sequence Number: 1
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