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 aesculap reference no.(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 aesculap reference no.(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 ais reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.Updated information: 3a patient sex, b5 adverse event updated, d6a d6b, implant and explant date.
Event or Problem Description
The patient underwent revision total knee arthroplasty of the right knee for loosening of prior components.The femoral component was removed using a microchoice and osteotome with minimal bone loss.The tibia was subluxed forward and a microchoice was used about the prosthesis to loosen it.The tibial component was able to be removed with minimal bone loss.Trial components were placed, and stable fixation with acceptable flexion/extension was achieved.A polyethylene insert was placed, and the joint was copiously irrigated.The patient tolerated the procedure, was awakened from anesthesia, and transferred to pacu in stable condition.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).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 the available lot number; the device was 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.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Additional information: b5 - description update.B7 - patient medical history.
Event or Problem Description
Update: a revision of the right knee total knee arthroplasty (tka) was performed (b)(6) 2024 due to gross instability.Findings included loose tibia and femur and patellar button.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Investigation results: the complained medical device was not made available for investigation.The investigation was based upon batch history review, historical data analysis, event description and review of a pictures.The provided pictures show the following situation: the femoral component (nx033z) shows bone cement adhesive on nearly the whole intended area.The tibial component (nx055z) shows bone cement residue on approximately half of the intended area.The device quality and manufacturing history records have been checked for the available lot number and were found to be according to the manufacturer's specifications, valid at the time of production.Review of the complaint history revealed that there are no similar complaints filed against the affected batch number.Conclusion/preventive measures: on the basis of the current information and without the complained medical device being available for investigation, a clear root cause cannot be drawn.In the event that the complained medical device will be provided for investigation in the future, an update of this report will be provided unsolicited.

• 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: 22205340
• Report Number: 3005673311-2025-00044
• Device Sequence Number: 7667975
• Product Code: JWH
• UDI-Device Identifier: 04046963810559
• UDI-Public: (01)04046963810559(11)210621(17)310620(10)52696448
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/06/2026
• Report Date (Section F): 06/09/2025

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: 52696448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2025
• Device Age: 41 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2025
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/27/2025; 09/08/2025; 09/30/2025; 12/09/2025; 04/06/2026
• 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: 57 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/09/2025