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

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 number: (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 no.(b)(4).Additional information: a3a patient sex.B5 event description updated.D1, d2, d4 suspected medical device information.D6a, d6b implant and explant date.F9 approximate age of device.
Event or Problem Description
Edit b5.The patient presented with pain and swelling of the left knee.Imaging demonstrated loosening of the vega knee system.On (b)(6) 2025, the patient underwent revision total knee arthroplasty of the left knee for loosening of prior components.Preoperative evaluation indicated aseptic loosening; no infection was detected.Intraoperatively, the tibial component was noted to be grossly loose with no cement present on any aspect of the implant.The femoral component was also loose and removed easily with light tapping.The patellar component was stable with no evidence of loosening.Findings were consistent with implant debonding at the cement interface.The femur and tibia were prepared, and revision femoral and tibial components were implanted using cement fixation.A polyethylene insert and modular augmentation components were placed for stability.An allograft and bone cement were also utilized.Final inspection confirmed stable fixation and appropriate alignment.The wound was irrigated, vancomycin powder was applied, and the capsule was closed.The patient tolerated the procedure and was transferred to pacu in stable condition.
Additional Manufacturer Narrative
The adverse event is filed under ais reference no.(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 no.(b)(4).Additional information: b6 - relevant test results.B7 - patient medical history.
Additional Manufacturer Narrative
The adverse event is filed under ais reference no.(b)(4).Investigation results: the complained medical device was not made available for investigation.The investigation was based upon historical data analysis, event description and review of pictures.The provided pictures show the following situation: the femoral component (nx018z) shows bone cement adhesive on nearly the whole intended area.The tibial component (nx059z) side shows nearly no bone cement residue.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 numbers.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/META
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 22206490
• Report Number: 3005673311-2025-00047
• Device Sequence Number: 6887843
• Product Code: JWH
• UDI-Device Identifier: 04046963810559
• UDI-Public: (01)04046963810559(11)211122(17)311121(10)52726062
• 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: 2025
• 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): 06/13/2025

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: 52726062
• 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: 39 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; 10/02/2025; 12/11/2025; 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: 52 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/13/2025