MAUDE Adverse Event Report: AESCULAP AG AS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	NR407Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a total knee replacement on (b)(6) 2017, with implantation of a vega system in the right knee.The tibial component reportedly loosened and required revision on (b)(6) 2018, at which time the vega system was again used for the bottom component.On (b)(6) 2019, a second revision was performed after the femoral component reportedly failed, and the construct was revised to a columbus af system.Despite the revisions, the patient continued to experience instability and pain.On (b)(6) 2022, a third revision was performed, and all aesculap components were removed and replaced with another manufacturer's device.While no further mechanical failure has occurred since that surgery, the patient continues to report chronic swelling, pain, and limited mobility in the right knee.The right knee is now visibly larger than the left, and the patient required a left knee replacement due to overcompensation.The explanted right knee components were returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Investigation results: visual inspection: the complained devices show several traces of use.The stem is still fixed in the tibial component.The tibial component shows massive damages caused due to external forces.The femoral component with the still fixed stem shows normal signs of use without any serious damages.Some bone cement residues are still adhesive on the intended area.The gliding surface of the meniscal component shows nearly no scratches or imprints.Batch history review: the device history records have been checked for all leading device(s) lot numbers and the products found to be according to specification valid at the time of production.There are no similar complaints against the same lot number.Conclusion/preventive measures: based on the current information a clear conclusion for the revision cannot be drawn.Besides the massive damages caused due to external forces most probably during the revision procedure, the explants show no deviation or visible failures.There is no indication for a design-, manufacturing- and/or material-related failure.

• Brand Name: AS
• 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: 22306729
• Report Number: 3005673311-2025-00068
• Device Sequence Number: 21022613
• Product Code: KRO
• UDI-Device Identifier: 04046963176570
• UDI-Public: (01)04046963176570(17)270430(10)52340573
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 08/08/2025
• Report Date (Section F): 06/23/2025

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 Model Number: NR407Z
• Device Catalogue Number: NR407Z
• Device Lot Number: 52340573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/23/2025