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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 62

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 62 Back to Search Results
Catalog Number 01.26.62MB
Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 09/23/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 23-oct-2019: lot 113446: 2 items manufactured and released on 28 september 2016. Expiration date: 2021-09-12. No anomalies found related to the problem. To date, all items of the same lot have been already sold without any similar reported event. Clinical evaluation performed by medical affairs department. Acetabular component revision performed 5 months after last revision surgery. An intraoperative fluoroscopic image was provided but it is not clear if it refers to the current revision or the previous one as no date is available. Information received concerning this event does not allow a proper clinical evaluation due to insufficient data. Additional device involved: liner: versafitcup dm 01. 26. 2862mhc double mobility hc liner 62/28 lot. 152697 (k092265) batch review performed on 23-oct-2019: lot 152697: 50 items manufactured and released on 03 august 2015. Expiration date: 2020-06-30. No anomalies found related to the problem. To date, 34 items of the same lot have been already sold without any similar reported event.
 
Event Description
The patient came in complaining of pain 5 months after previous surgery, the cause of the pain was a torn tendon. The surgeon performed an abductor tendon repair and revised the cup and liner. The surgery was completed successfully. The patient had a first revision surgery in (b)(6) 2018 performed due to hip dislocation and a second revision in (b)(6) 2019.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL Ø 62
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 Key9224548
MDR Text Key176280898
Report Number3005180920-2019-00886
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 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2021
Device Catalogue Number01.26.62MB
Device Lot Number113446
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2016
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: 10/23/2019 Patient Sequence Number: 1
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