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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS FEMUR EXTENS.STEM 6° D12X157 CEMENTED KNEE ENDOPROSTHESES

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AESCULAP AG AS FEMUR EXTENS.STEM 6° D12X157 CEMENTED KNEE ENDOPROSTHESES Back to Search Results
Model Number NR294Z
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. Batch history review - a review of the device quality and manufacturing history records was not possible because the lot numbers are unknown. Conclusion (broken stem)- it is not possible to determine a definitive root cause of the broken stem. It could be possible that this failure is usage/patient related. Rationale (broken stem) - product was not returned for investigation, so it is not possible to determine a root cause for the mentioned failure. It is mentioned that the patient had several revision operations with several implants. Therefore it can be assumed that the bone was prepared several times- little bone substance or possible bone defects of the patient. This led to the femur component not being supported enough and therefore the loading being transmitted through the femur box to the femur stem and the nut. If the load is too high, the component will break. Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that an enduro femoral stem broke and the patient underwent a revision. Prior to implantation of the enduro femoral stem, it was noted that the patient had previously undergone several total knee arthroplasties. The operation on (b)(6) 2013 and implantation of the enduro knee system had been a revision of a hinge prosthetic and the patient also required bone graft for condyles at that time. Over 5 years later, the patient was found to have a broken femoral stem, which was shown via x-rays 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. After some more efforts were made, the damaged locking nut was ejected as part of the femoral piece. The surgery was then continued as originally planned by removing the femoral stem, which was also difficult. Reconstruction of the femur was performed with use of 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. It was felt that perhaps the months of stress on the femoral component (from (b)(6) to (b)(6)) due to the broken femoral stem resulted in jamming of the nut. 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 revision and broken femoral stem. Associated medwatches: 9610612-2018-00599 ; 9610612-2018-00600 (this report); 9610612-2018-00619.
 
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Brand NameAS FEMUR EXTENS.STEM 6° D12X157 CEMENTED
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 Key8200199
MDR Text Key131527810
Report Number9610612-2018-00600
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 NumberNR294Z
Device Catalogue NumberNR294Z
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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