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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F2R KNEE ENDOPROSTHESES

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AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F2R KNEE ENDOPROSTHESES Back to Search Results
Model Number NB018Z
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 12/05/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: pictures were provided. When we receive the explanted devices, we will make an investigation in consultation with specialists from the development and marketing department. Investigation - no product at hand. This case was discussed with a specialist from the marketing department. According to the available figures, we assume that the tension screw is broken at the thread; and it could be seen that the locking nut was seriously damaged. Batch history review - a review of the device quality and manufacturing history records was not possible because the lot numbers are unknown. Conclusion (locking nut)- it is not possible to determine a definitive root cause of the failure of the locking nut. It could be possible that this failure is usage related. Rationale (locking nut)- it is not possible to determine a root cause for the mentioned failure of the locking nut. It could be possible that the locking nut has been tightened too much. Furthermore, it could be possible that the screw was tightened in a tilted position so that the thread was damaged and unscrewing was no longer possible. Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that a securing nut was difficult to unscrew during revision surgery. The initial surgery was in (b)(6) 2013 where an enduro knee system had been implanted. The revision was planned due to a broken femoral stem, which had occurred in (b)(6) 2018. The revision occurred on (b)(6) 2018, and the plan had been to remove and replace the femoral stem only. When the locking nut of the femoral component was attempted to be loosened, there was difficulty and it was not immediately successful. It was first attempted by using the instrument enduro holder/impactor for the locking nut and a torque wrench. Then the surgeon tried a clamp to enable the holder/impactor without result. He next tried to "destroy" the locking nut with a tungsten drill. To do this, the meniscal component was cut using a saw and chisel and access to the mechanism was gained. The interfacing bone was prepared and hammer and punch were used until the femoral component was ejected along with the axis. The damaged locking nut was ejected as part of the femoral piece. The surgery was continued as originally planned by removing the femoral stem, which was also difficult; and reconstructing the femur with small metaphyseal 35 and diaphyseal 30. There was implantation of the same size femoral component along with a stem and addition of 2-8x8 spacers. A new meniscal component with new axis was implanted; finally, the new femoral component was tightened through the locking nut with the above mentioned holder/impactor. It was felt that perhaps the months that the femoral stem had been broken and placed stress on the femoral component from (b)(6) to (b)(6) resulted in jamming of the nut and influenced the difficulty in removal. It was reported that there had been a surgical delay of greater than 15 minutes due to the difficulty in loosening the original nut. It was later noted that the threads on the tension screw (holder/impactor) were damaged/broken. This report addresses the femoral component which includes the locking nut. Associated medwatches: 9610612-2018-00599 (this report); 9610612-2018-00600; 9610612-2018-00619.
 
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Brand NameAS ENDURO FEMORAL COMPONENT CEMENTED F2R
Type of DeviceKNEE ENDOPROSTHESES
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8200415
MDR Text Key131581181
Report Number9610612-2018-00599
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K101815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNB018Z
Device Catalogue NumberNB018Z
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/07/2019
Event Location No Information
Date Manufacturer Received01/07/2019
Was Device Evaluated by Manufacturer? Yes
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: 12/27/2018 Patient Sequence Number: 1
Treatment
REF: NB012Z, TIBIAL COMPONENT; REF: NR195Z, TIBIA OFFSET STEM; REF: NR377Z, FEMORAL SPACER; REF: NR400Z, NUT F/FEMUR EXTENS. STEM; REF: NR883Z, MENISCAL COMPONENT
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