MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F2L; KNEE ENDOPROSTHETICS

Model Number	NB015Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with nb015z - as enduro femoral component cemented f2l.According to the complaint description, the revision due to aseptic loosening was 3 years 5 months post surgery.Original date of surgery: (b)(6) 2017.Date of revision surgery: (b)(6) 2021.A revision surgery was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: nr400z - as nut f/femur extens.Stem all sz.Neutr.- lot 52211649.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.Nb011z - as enduro tibial comp.Offset cemented t1 - lot 52328619.
Event or Problem Description
Involved components: nr400z - as nut f/femur extens.Stem all sz.Neutr.- lot 52211649; 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; nb011z - as enduro tibial comp.Offset cemented t1 - lot 52328619.
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F2L
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12167184
• Report Number: 9610612-2021-00504
• Device Sequence Number: 3704763
• Product Code: KRO
• UDI-Device Identifier: 04046963177492
• UDI-Public: 4046963177492
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K101815
• 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: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: NB015Z
• Device Catalogue Number: NB015Z
• Device Lot Number: 52357231
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 10/19/2021
• 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 - LOT 52328619; NB011Z - LOT 52328619; NR194Z - LOT 52257685; NR194Z - LOT 52257685; NR292Z - LOT 52295198; NR292Z - LOT 52295198; NR400Z - LOT 52211649; NR400Z - LOT 52211649; NR865Z - LOT 51905538; NR865Z - LOT 51905538; NR865Z - LOT 52287175; NR865Z - LOT 52287175; NR884Z - LOT 52318309; NR884Z - LOT 52318309
• Outcome Attributed to Adverse Event: Required Intervention