• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 52/28

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 52/28 Back to Search Results
Catalog Number 01.26.2852M
Device Problems Material Discolored (1170); Device Contamination with Chemical or Other Material (2944); Naturally Worn (2988)
Patient Problem Pain (1994)
Event Date 02/26/2018
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 26 march 2018 (b)(4). Clinical evaluation performed by medical affairs director on 27 march 2018. Hip revision surgery occurred 8 years after primary dm tha. Pictures provided show the presence of a foreign body in the polyethylene double mobility liner. The nature and origin of this object cannot be determined on the basis of information available. The potential role that this finding may have had in the generation of pain is unknown. According to report, components from two different manufacturers were used in the assembly. The coupling of parts that were not designed to be assembled may have unpredictable consequences, but there are not enough elements to analyse potential influence of this situation. Preliminary investigation performed on 28 march 2018 by r and d product manager: from the images we cannot define which material is included in the hole of the liner. Usually, coagulated residual blood can be noted in such a hole. The radiographic images do not show evidence of metallic debris. Different slices could confirm the absence of metallic debris in the hole. Anyway, the external surface of the liner is damaged: that was probably caused by a third external body.
 
Event Description
The patient came in complaining of pain and clicking of the hip 8 years after primary. Upon removal of the liner the surgeon noticed a black dot on the outside top of the liner. The visible black dot on the outside of the liner extended through the entire liner. When the surgeon cracked it open, a piece of it came out. It was not a blood clot. There was visible wear at the apex of the inside of the liner which was a yellowish color and the rest of the liner was white. The surgeon implanted a medacta liner with another company's head. The surgery was completed successfully. The agent reported that surgeon said it sounded like trunnionosis. Especially due to the fact the head and stem were mismatched companies. Note: another company's stem used in primary.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVERSAFITCUP DM DOUBLE MOBILITY LINER Ø 52/28
Type of DeviceDOUBLE MOBILITY LINER
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, 6874
SZ   6874
MDR Report Key7377661
MDR Text Key103700563
Report Number3005180920-2018-00186
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 other
Reporter Occupation
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2014
Device Catalogue Number01.26.2852M
Device Lot Number092654
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2009
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: 03/28/2018 Patient Sequence Number: 1
-
-