MAUDE Adverse Event Report: AESCULAP AG AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	NR400Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem 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 or Problem Description
No updates required.
Additional 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.

• Brand Name: AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12137706
• Report Number: 2916714-2021-00128
• Device Sequence Number: 4615552
• Product Code: KRO
• UDI-Device Identifier: 04046963367732
• UDI-Public: 4046963367732
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021
• Report Date (Section F): 07/08/2021

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
• Operator of Device: No Information
• Device Expiration Date: 01/31/2026
• Device Model Number: NR400Z
• Device Catalogue Number: NR400Z
• Device Lot Number: 52211649
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/13/2021
• Device Age: 64 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 07/08/2021