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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-UNI ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE 5 LM/RL
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MEDACTA INTERNATIONAL SA GMK-UNI ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE 5 LM/RL Back to Search Results
Catalog Number 02.08.305LMRL
Device Problem Device Slipped (1584)
Patient Problem Joint Disorder (2373)
Event Date 09/13/2018
Event Type  Injury  
Manufacturer Narrative
The batch review performed on 12 october 2018; lot 173834: (b)(4) items manufactured and released on 23 october 2017.Expiration date: 2022-09-24 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.Clinical evaluation performed by medical affairs director on october 10, 2018 mobilization of femoral component in cemented primary uka few weeks after index operation.According to the report, the cement adhered to the component but not to the bone, and this may have caused insufficient fixation.It is conceivable that the origin of the failure may be sought in the cementation procedure or in problems with the cement itself (such as temperature, timing, temperature of stackage,.).No clue that the fault may have been originated by a defect in the implanted device.
 
Event Description
Revision surgery performed due to femoral loosening 4 months after primary.The patient was suffering from pain.During the revision surgery the femoral component was found completely tilted with no cement on the posterior part of the condyle; cement remained stuck on the implant in its distal part.After trying to implant the same size of the femoral component the surgeon revealed again a tilting effect.The post and chamfer cuts were re-performed with good stability achieved.The tibial plateau in full pe being stable it is left in place.
 
Manufacturer Narrative
Clinical evaluation performed by r&d project manager: mobilization of anatomical femoral component in cemented primary uka 3 months after primary surgery.Femoral component was found completely loosened in the joint.No cement can be seen on the internal surface of the component.Absence or lack of cement on explanted components is usual to be seen even if the cause of revision is not loosening or mobilization.Therefore this is not an evidence of lack of adhesion between the cement and the implant due to faulty devices.Furthermore no non-conformity can be revealed in the distal surface of the component that could have contributed to the event.Poor cement inter-digitation on the implant surface are of various origin; they could be related to the cement and cementation procedure.Mobilization of the implant during curing (maybe linked to a imperfect preparation of the bone as partially confirmed during revision surgery when the surgeon tried to position a femur of the same size and detected a tilting effect of the back and forth around the chamfer) could be another cause of failure of the cementation process.
 
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Brand Name
GMK-UNI ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE 5 LM/RL
Type of Device
ANATOMICAL FEMORAL COMPONENT CEMENTED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7959566
MDR Text Key123488081
Report Number3005180920-2018-00782
Device Sequence Number1
Product Code HSX
UDI-Device Identifier07630030804199
UDI-Public07630030804199
Combination Product (y/n)N
PMA/PMN Number
K161741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/24/2022
Device Catalogue Number02.08.305LMRL
Device Lot Number173834
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2018
Date Manufacturer Received09/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient Weight90
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