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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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AESCULAP AG AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number NR400Z
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
 
Event Description
It was reported to aesculap inc.That an as nut f/femur extens.Stem all sz.Neutr (part # nr400z) was implanted during a primary procedure performed on (b)(6) 2017.According to the complainant, aseptic loosening of the femoral component occurred.The patient underwent a revision procedure on (b)(6) 2021.The complaint device has not been returned to the manufacturer for evaluation.No patient complications occurred as a result of the revision procedure.Concomitant devices: nr194z - as tibia offset stem d12x92mm cemented - lot # 52257685, nr865z - as enduro femur spacer distal f2 8mm - lot # 52287175, nr865z - as enduro femur spacer distal f2 8mm - lot # 51905538, nr292z - as femur extens.Stem 6° d15x77 cemented - lot # 52295198, nr884z - as enduro meniscal component f2 18mm - lot # 52318309, nb015z - as enduro femoral component cemented f2l - lot # 52357231, nb011z - as enduro tibial comp.Offset cemented t1 - lot # 52328619.
 
Event Description
No updates required.
 
Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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Brand Name
AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key12137706
MDR Text Key261601512
Report Number2916714-2021-00128
Device Sequence Number1
Product Code KRO
UDI-Device Identifier04046963367732
UDI-Public4046963367732
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 07/08/2021,10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberNR400Z
Device Catalogue NumberNR400Z
Device Lot Number52211649
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/08/2021
Distributor Facility Aware Date06/13/2021
Device Age64 MO
Event Location Hospital
Date Report to Manufacturer06/13/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/08/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NB011Z - AS ENDURO TIBIAL COMP.OFFSET CEMENTED T1; NB015Z - AS ENDURO FEMORAL COMPONENT CEMENTED F2L; NR194Z - AS TIBIA OFFSET STEM D12X92MM CEMENTED -; NR292Z - AS FEMUR EXTENS.STEM 6° D15X77 CEMENTED -; NR865Z - AS ENDURO FEMUR SPACER DISTAL F2 8MM - LO; NR865Z - AS ENDURO FEMUR SPACER DISTAL F2 8MM - LO; NR884Z - AS ENDURO MENISCAL COMPONENT F2 18MM - LO
Patient Outcome(s) Required Intervention;
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