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

Model Number	NX062Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that there was an issue with a component of columbus knee system.According to the complaint description, this knee implant was "defective and failed prematurely because the ceramic coated surface fails to properly adhere to the cement".There was postoperative mechanical loosening.It was noted that the surgeon easily removed the implant by hand during the revision.Additional information was not provided.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation results: 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.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, 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.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Additional information: a section - patient initials.
Additional Manufacturer Narrative
The adverse event is filed under aic reference: (b)(4).Additional information: patient information: a3, a4.Event description updated: b5.Relevant history: b7.D1 brand name, d2a common device name, d2b product code.D4 item information updated.D6a, d6b, implant and explant dates.F9 approximate age of device.
Event or Problem Description
An outside law firm reported that a patient experienced issues following a left knee prosthesis that required subsequent medical intervention.According to the operative report dated on (b)(6) 2022, a patient underwent a left total knee arthroplasty for osteoarthritis.The procedure was performed using cemented knee components (aesculap system) with palacos bone cement.The operative report indicates the patient tolerated the procedure well with no intraoperative complications, and the implants were placed with appropriate alignment and stability.According to a subsequent operative report dated on (b)(6) 2023, the patient underwent a revision left total knee arthroplasty due to aseptic loosening of the femoral and tibial components.Intraoperatively, both components were noted to be grossly loose, with no cement adherent to the implants.The components were removed without significant bone loss.Revision was performed using stemmed femoral and tibial components, bone cement, and adjunctive materials including antibiotic beads.Final implantation demonstrated stable fixation with appropriate alignment and full range of motion without instability.The patient tolerated the procedure and was transferred to recovery in stable condition with no intraoperative complications reported.A follow-up clinic note dated on (b)(6) 2025, documents ongoing left knee pain and effusion.Range of motion was reported as normal with maintained alignment.No infection was documented.

• Brand Name: AS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 22285670
• Report Number: 3005673311-2025-00062
• Device Sequence Number: 8922018
• Product Code: JWH
• UDI-Device Identifier: 04046963810559
• UDI-Public: (01)04046963810559(11)220128(17)320127(10)52742140
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2026
• Report Date (Section F): 06/18/2025

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: NX062Z
• Device Catalogue Number: NX062Z
• Device Lot Number: 52742140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/29/2025
• Device Age: 23 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/03/2025; 12/09/2025; 03/23/2026
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Date Report Sent to FDA: 06/18/2025