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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 46 CEMENTLESS HIP SHELL

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 46 CEMENTLESS HIP SHELL Back to Search Results
Catalog Number 01.26.46MB
Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/07/2018
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 06 december 2018: lot 113444: (b)(4) pieces released on 30 august 2016. Expiration date: 2021-08-16 -totally, (b)(4) pieces produced- 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. Comment provided by medical affairs director: according to the surgeon, the issue was caused by having implanted a too big size for that patient, so no further analysis is necessary.
 
Event Description
The patient came in complaining of pain. The cause of pain was due to irritation of the psoas caused by the versafit dm cup being too large for the patients anatomy. The surgeon burred the edge of the dm cup to better fit the patients anatomy and revised the liner with another company's product. The surgeon revised the head with a medacta head and the surgery was completed successfully.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL Ø 46
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 Key8141702
MDR Text Key129600823
Report Number3005180920-2018-00968
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 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/16/2021
Device Catalogue Number01.26.46MB
Device Lot Number113444
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/13/2011
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: 12/07/2018 Patient Sequence Number: 1
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