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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 54 HIP ACETABULAR SHELL

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 54 HIP ACETABULAR SHELL Back to Search Results
Catalog Number 01.26.54MB
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Joint Disorder (2373)
Event Date 10/22/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 25 october 2019: lot 082537: 8 items manufactured and released on 11-dec-2008. Expiration date: 2013-10-31. 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. Additional device involved in the complaint. Batch review performed on 25 october 2019: liner: versafitcup dm 01. 26. 2854m double mobility liner ø 54/28 (k083116) lot 082980: 24 items manufactured and released on 09-dec-2008. Expiration date: 2013-10-31. No anomalies found related to the problem. To date, 23 items of the same lot have been already sold without any other similar reported event.
 
Event Description
The patient came in complaining of pain due to a loose cup that was caused from osteolysis. The surgeon revised the cup, liner, and head almost 10 years and 5 months after primary. The surgery was completed successfully.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL Ø 54
Type of DeviceHIP ACETABULAR 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 Key9334637
MDR Text Key167980610
Report Number3005180920-2019-00969
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 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2013
Device Catalogue Number01.26.54MB
Device Lot Number082537
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/11/2008
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: 11/18/2019 Patient Sequence Number: 1
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