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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL 50 HIP UNCEMENTED SHELL

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MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL 50 HIP UNCEMENTED SHELL Back to Search Results
Model Number 01.26.50MB
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Joint Disorder (2373)
Event Date 06/29/2020
Event Type  Injury  
Manufacturer Narrative
Batch review performed on (b)(6) 2020: lot 133925: 40 items manufactured and released on 24-oct-2013. Expiration date: 2018-09-30. 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 since 2016.
 
Event Description
The patient came in reporting groin pain due to cup impingement. The surgeon revised the medacta cup and liner with another company's product and revised the medacta head with a medacta head 6 years and 2 months after primary. The surgery was completed successfully.
 
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Brand NameVERSAFITCUP ACETABULAR SHELL 50
Type of DeviceHIP UNCEMENTED 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 Key10294918
MDR Text Key199537325
Report Number3005180920-2020-00447
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 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2018
Device Model Number01.26.50MB
Device Catalogue Number01.26.50MB
Device Lot Number133925
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/24/2013
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: 07/20/2020 Patient Sequence Number: 1
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