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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ENDURO MENISCAL COMPONENT F2 10MM; GLIDING SURFACES/PATELLAS ENDURO
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AESCULAP IMPLANT SYSTEMS ENDURO MENISCAL COMPONENT F2 10MM; GLIDING SURFACES/PATELLAS ENDURO Back to Search Results
Model Number NR880M
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.
 
Event Description
Country of complaint: (b)(6).Enduro implantation from 2014 had to be revised on (b)(6) 2018 due to the patient recognized an instability.A x-ray picture showed the loosened locking nut which lay behind the tibia implant.The implant was uncoupled.Intraoperatively was noticed that the head of axis with the locking ring was broken.After removing from locking nut the inlay with another nut, axis and gliding bush were removed.A new axis, with a gliding bush and nut was implanted.Coupling with femur implant without any problems.
 
Manufacturer Narrative
(b)(4).Exemption number: e2014018.Manufacturing site evaluation: evaluation on-going.Device not returned.
 
Event Description
Country of complaint: (b)(6).Enduro implantation from 2014 had to be revised on (b)(6) 2018 due to the patient recognized an instability.A x-ray picture showed the loosened locking nut which lay behind the tibia implant.The implant was uncoupled.Intraoperatively was noticed that the head of axis with the locking ring was broken.After removing from locking nut the inlay with another nut, axis and gliding bush were removed.A new axis, with a gliding bush and nut was implanted.Coupling with femur implant without any problems.Components in use listed as concomitant devices are: nr880m / enduro meniscal component f2 10mm; nb018k / enduro femoral component cemented f2r; nr292k / femur extens.Stem 6° d15x77mm cemented; nb045k / enduro tibia hemi-wedge t2 4mm rm/ll; nb012k / enduro tibial comp.Offset cemented t2; nr192k / tibia offset stem d15x52mm cemented; nr400k / nut f/femur extens.Stem all sizes neutr.Nk916 / mset resorb.Intramedullary plug 16mm; nk914 / imset resorb.Intramedullary plug 14mm; ge246su / disp.Saw blade rapid action 90/23/1.27mm.
 
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Brand Name
ENDURO MENISCAL COMPONENT F2 10MM
Type of Device
GLIDING SURFACES/PATELLAS ENDURO
Manufacturer (Section D)
AESCULAP IMPLANT SYSTEMS
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key7392443
MDR Text Key104264557
Report Number9610612-2018-00133
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K101815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2019
Device Model NumberNR880M
Device Catalogue NumberNR880M
Device Lot Number52083870
Was Device Available for Evaluation? No
Distributor Facility Aware Date03/23/2018
Device Age3 YR
Date Manufacturer Received03/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GE246SU / DISP.SAW BLADE RAPID ACTION 90/23/1.27MM; NB012K / ENDURO TIBIAL COMP.OFFSET CEMENTED T2; NB018K / ENDURO FEMORAL COMPONENT CEMENTED F2R; NB045K / ENDURO TIBIA HEMI-WEDGE T2 4MM RM/LL; NK914 / IMSET RESORB.INTRAMEDULLARY PLUG 14MM; NK916 / MSET RESORB.INTRAMEDULLARY PLUG 16MM; NR192K / TIBIA OFFSET STEM D15X52MM CEMENTED; NR292K / FEMUR EXTENS.STEM 6° D15X77MM CEMENTED; NR400K / NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR.; NR880M / ENDURO MENISCAL COMPONENT F2 10MM
Patient Outcome(s) Other;
Patient Age68 YR
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