AS NX060ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04046963655808), received between Sep 8, 2025 and Aug 17, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (20 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Patient-Device Incompatibility

  An outside law firm reported that a patient experienced loosening of the right knee prosthesis. The patient underwent right total knee arthroplasty on (b)(6), 2018 for right knee degenerative joint disease. The operative report documents implantation of total knee arthroplasty components. The procedure was completed without reported intraoperative complications, and the patient was transferred to the PACU in stable condition. Postoperative follow-up on (b)(6), 2018 documented that the right knee was straight and anatomically aligned and that the patient had no complaints or problems. On (b)(6), 2018, the patient reported feeling something "pop" anteriorly around the knee and had anterior tenderness. Radiographs were reported as completely normal. The patient received an intramuscular Depo-Medrol injection for pain and swelling. At follow-up on (b)(6), 2018, the patient was reported to be significantly improved, although some lateral collateral ligament symptoms remained. On (b)(6), 2018, the patient was reported to be doing fairly well, with keloid formation/scarring and continued patellofemoral pain. On (b)(6), 2026, approximately eight years after the index arthroplasty, the pati

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 50275306 ↗
• InjuryAug 14, 2026Patient-Device Incompatibility

  An outside law firm reported that a patient experienced postoperative loosening and instability following a right total knee arthroplasty. According to the available medical records, the patient underwent a right total knee arthroplasty on (b)(6) 2021. The patient subsequently developed loosening of the right total knee arthroplasty with gross instability. On (b)(6) 2024, the patient underwent revision right total knee arthroplasty involving the femoral and tibial components. The preoperative and postoperative diagnoses were documented as right knee loose total knee arthroplasty with gross instability. During the revision procedure, the femoral component was visualized and reportedly came right off when grasped. The tibial prosthesis was loosened and removed easily with minimal bone loss. The patellar button was also assessed intraoperatively and was documented to be loose. The femur and tibia were prepared for revision components. Following trialing, the knee demonstrated full range of motion with excellent stability to varus and valgus stress. The revision components were cemented into place using a third-generation cement technique. The patient was awakened from surgery and take

  Patient problems: Insufficient Information

  MAUDE report 50260853 ↗
• InjuryAug 14, 2026Patient-Device Incompatibility

  An outside law firm reported that a patient experienced postoperative loosening following a left total knee arthroplasty. According to the available medical records, the patient underwent a left total knee arthroplasty on (b)(6) 2021. On (b)(6) 2024, the patient underwent revision of the left patellar component for aseptic loosening. The operative report documented that the femoral and tibial components were inspected and appeared to have no loosening. The patellar button was evaluated, and when an osteotome was placed at the medial side of the button, the button reportedly popped out. The remaining cement was removed from the patella and the patella was resurfaced to allow for improved tracking. No intraoperative complications were reported, and the patient was taken to recovery in stable condition. Subsequent records documented further concerns involving the left total knee prosthesis. At a (b)(6) 2025 postoperative evaluation, radiographs demonstrated a posterior-stabilized total knee replacement with the patella resurfaced. The femoral component appeared loose, with severe periprosthetic osteolysis about the femur. The patient was assessed with mechanical loosening and peripros

  Patient problems: Insufficient Information

  MAUDE report 50260355 ↗
• InjuryJun 12, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING COMPLICATIONS ASSOCIATED WITH A VEGA KNEE IMPLANT. A REVISION SURGERY HAS NOT YET BEEN SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. THIS REPORT IS FILED UNDER AIS REFERENCE XC (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25484822 ↗
• InjuryJun 10, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS ASSOCIATED WITH A LEFT TOTAL KNEE REPLACEMENT (TKR). ACCORDING TO CLINICAL DOCUMENTATION, THE PATIENT INITIALLY UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2022. FOLLOWING THE TOTAL KNEE REPLACEMENT, THE PATIENT EXPERIENCED PERSISTENT SYMPTOMS, INCLUDING PAIN, INSTABILITY, RECURRENT BUCKLING, AND LIMITED FUNCTION OF THE LEFT KNEE. AN OFFICE VISIT DATED (B)(6) 2023 DOCUMENTED 3+ EFFUSION AND LATERAL LAXITY, WITH CONCERN FOR INSTABILITY. DUE TO ONGOING SYMPTOMS, THE PATIENT UNDERWENT REVISION LEFT KNEE ARTHROPLASTY ON (B)(6) 2023. OPERATIVE FINDINGS INCLUDED LOOSENING OF THE TIBIAL COMPONENT WITH OBSERVED MICROMOTION. THE PROCEDURE INVOLVED REMOVAL OF THE LOOSENED COMPONENT AND IMPLANTATION OF A REVISED TIBIAL COMPONENT WITH POLYETHYLENE INSERT. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. PATIENT UNDERWENT REVISION LEFT KNEE ARTHROPLASTY ON (B)(6) 2026. THIS REPORT IS FILED UNDER AIS REFERENCE XC (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25461709 ↗
• InjuryJun 9, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING COMPLICATIONS ASSOCIATED WITH A KNEE IMPLANTS. SPECIFICALLY, IT WAS REPORTED THAT THERE WAS POSTOPERATIVE LOOSENING. A REVISION SURGERY HAD BEEN PLANNED. PATIENTS ALSO ALLEGED CHRONIC, WORSENING RIGHT KNEE PAIN IN THE SETTING OF PRIOR RIGHT KNEE SURGERIES, INCLUDING TOTAL KNEE ARTHROPLASTY AND REVISION PROCEDURES. PHYSICAL EXAMINATION DEMONSTRATED SWELLING AND TENDERNESS OF THE RIGHT KNEE JOINT WITH IMPAIRED MOBILITY, INCLUDING DIFFICULTY TURNING WHILE AMBULATING AND USE OF A CANE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET PROVIDED. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25443907 ↗
• InjuryMay 1, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES FOLLOWING A LEFT KNEE PROSTHESIS. ACCORDING TO AVAILABLE RECORDS, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, FOR DEGENERATIVE JOINT DISEASE. SUBSEQUENTLY, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021. BOTH PROCEDURES WERE REPORTED TO BE COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POSTOPERATIVELY, THE PATIENT INITIALLY REPORTED IMPROVEMENT. AT FOLLOW-UP ON (B)(6) 2021, THE PATIENT WAS NOTED TO BE DOING WELL WITHOUT PAIN OR COMPLAINTS. ON (B)(6) 2022, THE PATIENT REPORTED A FALL WITH SUBSEQUENT LEFT KNEE PAIN, DECREASED RANGE OF MOTION, AND INSTABILITY. IMAGING AND CLINICAL FINDINGS AT THAT TIME NOTED DEGENERATIVE CHANGES AND LIGAMENTOUS LAXITY. THE PATIENT CONTINUED TO REPORT PERSISTENT KNEE SYMPTOMS DESPITE CONSERVATIVE MANAGEMENT, INCLUDING INJECTIONS. ON (B)(6) 2022, THE PATIENT REPORTED ONGOING KNEE PAIN; IMAGING AT THAT TIME DID NOT DEMONSTRATE LOOSENING. AT FOLLOW-UP ON (B)(6) 2026, IMAGING DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH FINDINGS OF MECHANICAL LOOSENING OF THE FEMORAL COMPONENT, ASSOCIATED LUCENCY, AND INSTABILITY. CLINICAL EXAMIN

  Patient problems: Failure of Implant

  MAUDE report 25055701 ↗
• InjuryApr 30, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED FAILURE OF A RIGHT KNEE PROSTHESIS THAT REQUIRED REVISION SURGERY. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2025, THE PATIENT UNDERWENT REVISION ARTHROPLASTY OF THE RIGHT KNEE DUE TO A FAILED AESCULAP TOTAL KNEE REPLACEMENT. THE OPERATIVE REPORT INDICATES THAT THE FEMORAL COMPONENT DEMONSTRATED DEBONDING AND DELAMINATION OF THE BONE CEMENT FROM THE POSTERIOR ASPECT OF THE FEMORAL COMPONENT, AND THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE. THE EXISTING PROSTHETIC COMPONENTS AND RESIDUAL BONE CEMENT WERE REMOVED DURING THE PROCEDURE. THE FEMUR AND TIBIA WERE PREPARED AND REVISION COMPONENTS WERE IMPLANTED USING BONE CEMENT. TRIALING REPORTEDLY DEMONSTRATED STABILITY THROUGH RANGE OF MOTION WITHOUT VARUS OR VALGUS LAXITY. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY FOLLOWING THE PROCEDURE. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED IN THE OPERATIVE RECORD. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25050204 ↗
• InjuryApr 27, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES FOLLOWING A LEFT KNEE PROSTHESIS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2021 FOR DEGENERATIVE JOINT DISEASE. THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POSTOPERATIVELY, THE PATIENT INITIALLY REPORTED IMPROVEMENT, WITH FOLLOW-UP ON (B)(6) 2021 NOTING THAT THE PATIENT WAS DOING WELL WITH NO PAIN OR COMPLAINTS. HOWEVER, BY FEBRUARY 21, 2022, THE PATIENT REPORTED A FALL WITH SUBSEQUENT LEFT KNEE PAIN, DECREASED RANGE OF MOTION, AND LIGAMENTOUS INSTABILITY. IMAGING AND CLINICAL FINDINGS AT THAT TIME NOTED DEGENERATIVE CHANGES AND LAXITY. THE PATIENT CONTINUED TO REPORT PERSISTENT KNEE SYMPTOMS DESPITE CONSERVATIVE MANAGEMENT, INCLUDING INJECTIONS. BY JUNE 24, 2022, THE PATIENT REPORTED ONGOING KNEE PAIN, THOUGH IMAGING DID NOT DEMONSTRATE LOOSENING AT THAT TIME. AT FOLLOW-UP ON (B)(6), 2026, IMAGING DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH FINDINGS OF MECHANICAL LOOSENING OF THE FEMORAL COMPONENT, ASSOCIATED LUCENCY, AND INSTABILITY. CLINICAL EXAMINATION CONFIRMED LIGAMENTOUS LAXITY, EFFUSION, AND PAIN. DIAGNOSES INCLUD

  Patient problems: Failure of Implant

  MAUDE report 24999157 ↗
• InjuryApr 27, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES INVOLVING THE RIGHT KNEE FOLLOWING DEGENERATIVE JOINT DISEASE AND SUBSEQUENT SURGICAL INTERVENTION. ACCORDING TO CLINICAL DOCUMENTATION, THE PATIENT PRESENTED ON (B)(6) 2021 WITH CHRONIC RIGHT KNEE PAIN DUE TO END-STAGE OSTEOARTHRITIS, HAVING FAILED CONSERVATIVE MANAGEMENT INCLUDING MULTIPLE INJECTIONS. A RIGHT TOTAL KNEE ARTHROPLASTY WAS RECOMMENDED. THE PATIENT SUBSEQUENTLY UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021. OPERATIVE RECORDS INDICATE THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS, WITH PROPER PLACEMENT OF PROSTHETIC COMPONENTS AND STABLE RANGE OF MOTION ACHIEVED INTRAOPERATIVELY. FOLLOWING SURGERY, THE PATIENT WAS SEEN ON (B)(6) 2021 AFTER A REPORTED FALL, WITH CONTINUED PAIN BUT NO IMMEDIATE EVIDENCE OF SURGICAL FAILURE. AT FOLLOW-UP ON (B)(6) 2022, THE PATIENT WAS NOTED TO BE RECOVERING FAIRLY WELL, THOUGH SHE HAD DIFFICULTY ATTENDING PHYSICAL THERAPY AND CONTINUED TO HAVE WEAKNESS. ON (B)(6) 2022, THE PATIENT REPORTED ONGOING KNEE PAIN WITH EPISODES OF INSTABILITY AND FALLS, WITH EXAMINATION NOTING LIGAMENTOUS LAXITY. ADDITIONAL TREATMENT INCLUDED A CORTICOSTEROID I

  Patient problems: Failure of Implant

  MAUDE report 24998746 ↗
• InjuryApr 27, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES FOLLOWING A LEFT KNEE PROSTHESIS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6), 2020 FOR DEGENERATIVE JOINT DISEASE. THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POSTOPERATIVELY, THE PATIENT REPORTED PERSISTENT LEFT KNEE PAIN DESPITE CONSERVATIVE MANAGEMENT, INCLUDING PHYSICAL THERAPY AND CORTICOSTEROID INJECTIONS. CLINICAL NOTES DOCUMENT CONTINUED PAIN IN MULTIPLE REGIONS OF THE KNEE. BONE SCAN IMAGING LATER DEMONSTRATED INCREASED ACTIVITY AT THE TIP OF THE LEFT TIBIAL STEM WITH ASSOCIATED PAIN, NOTED AS POSSIBLY REPRESENTING LOOSENING OR PHYSIOLOGIC CHANGE. AT FOLLOW-UP ON (B)(6) 2026, IMAGING DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH LUCENCY AT THE FEMORAL COMPONENT (POSTERIOR CUT) AND THE FEMORAL COMPONENT APPEARING LOOSE. CLINICAL FINDINGS INCLUDED PAIN AND SUPRAPATELLAR CLUNK, WITH DIAGNOSES OF MECHANICAL LOOSENING AND INSTABILITY OF THE LEFT KNEE PROSTHETIC JOINT. NO REVISION SURGERY OR INFECTION WAS DOCUMENTED IN THE AVAILABLE RECORDS. THIS REPORT IS FILED UNDER AIS REFERENCE XC (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24998406 ↗
• InjuryApr 23, 2026Patient-Device Incompatibility

  THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24971207 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS FOLLOWING A RIGHT KNEE PROSTHESIS THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2021, THE PATIENT UNDERWENT A PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY FOR TRICOMPARTMENTAL DEGENERATIVE JOINT DISEASE (DJD) WITH VARUS DEFORMITY. THE PROCEDURE WAS PERFORMED USING AESCULAP VEGA COMPONENTS, WHICH WERE CEMENTED IN PLACE USING PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THAT THE COMPONENTS WERE IMPLANTED WITH APPROPRIATE ALIGNMENT AND STABILITY, WITH CENTRAL PATELLAR TRACKING AND NO EVIDENCE OF VARUS OR VALGUS INSTABILITY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO RECOVERY IN GOOD CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED JUNE 30, 2025, THE PATIENT UNDERWENT A REVISION RIGHT TOTAL KNEE ARTHROPLASTY DUE TO FAILURE OF THE PRIOR KNEE REPLACEMENT WITH LOOSENING OF COMPONENTS. INTRAOPERATIVELY, BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE NOTED TO BE LOOSE WITH FRAGMENTATION OF CEMENT AND WERE REMOVED WITHOUT SIGNIFICANT DIFFICULTY. REVISION WAS PERFORMED USING ANOTHER MANUFACTURER'S COMPONENTS

  Patient problems: Failure of Implant

  MAUDE report 24653677 ↗
• InjuryMar 19, 2026Patient-Device Incompatibility

  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 (B)(6) 2021, THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY FOR TRICOMPARTMENTAL DEGENERATIVE JOINT DISEASE (DJD) WITH MARKED TIBIAL TORSION. THE PROCEDURE WAS PERFORMED USING AESCULAP COMPONENTS, WHICH WERE CEMENTED IN PLACE USING PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THAT THE COMPONENTS WERE IMPLANTED WITH APPROPRIATE ALIGNMENT AND STABILITY, AND THE PATIENT WAS TAKEN TO RECOVERY IN GOOD CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED (B)(6) 2023, THE PATIENT UNDERWENT LEFT KNEE MANIPULATION UNDER ANESTHESIA DUE TO POSTOPERATIVE ADHESIVE CAPSULITIS. THE PROCEDURE INVOLVED MANIPULATION OF THE KNEE FROM FULL EXTENSION TO APPROXIMATELY 125 DEGREES OF FLEXION. NO AUDIBLE OR PALPABLE ABNORMALITIES WERE NOTED, AND NO STRUCTURAL CHANGES TO THE KNEE WERE IDENTIFIED DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO RECOVERY IN GOOD CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 24639440 ↗
• InjuryMar 18, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED FAILURE OF A LEFT KNEE PROSTHESIS THAT REQUIRED REVISION SURGERY. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2025, THE PATIENT UNDERWENT REVISION ARTHROPLASTY OF THE LEFT KNEE DUE TO A FAILED LEFT AESCULAP TOTAL KNEE REPLACEMENT. THE OPERATIVE REPORT INDICATES THAT THE FEMORAL COMPONENT DEMONSTRATED DEBONDING AND DELAMINATION OF THE BONE CEMENT FROM THE POSTERIOR ASPECT OF THE FEMORAL COMPONENT, AND THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE. THE EXISTING PROSTHETIC COMPONENTS AND RESIDUAL BONE CEMENT WERE REMOVED DURING THE PROCEDURE. THE FEMUR AND TIBIA WERE PREPARED AND REVISION COMPONENTS WERE IMPLANTED USING BONE CEMENT. TRIALING REPORTEDLY DEMONSTRATED STABILITY THROUGH RANGE OF MOTION WITHOUT VARUS OR VALGUS LAXITY. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY FOLLOWING THE PROCEDURE. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED IN THE OPERATIVE RECORD.

  Patient problems: Failure of Implant

  MAUDE report 24634558 ↗
• InjuryMar 16, 2026Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT, ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION ARTHROPLASTY OF THE RIGHT KNEE DUE TO A FAILED UNICOMPARTMENTAL KNEE REPLACEMENT. DURING THE PROCEDURE, THE COMPONENTS WERE EXPOSED AND REMOVED, AND THE KNEE WAS CONVERTED TO A TOTAL KNEE ARTHROPLASTY. TRIAL COMPONENTS DEMONSTRATED APPROPRIATE ALIGNMENT AND STABILITY. THE FINAL COMPONENTS WERE IMPLANTED USING BONE CEMENT. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION WITH NO INTRAOPERATIVE COMPLICATIONS REPORTED. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT UNDERWENT AN ADDITIONAL REVISION PROCEDURE OF THE RIGHT KNEE. DURING THE PROCEDURE, THE EXISTING COMPONENTS AND RESIDUAL CEMENT WERE REMOVED. THE FEMUR AND TIBIA WERE PREPARED, AND NEW COMPONENTS WERE IMPLANTED WITH BONE CEMENT. TRIALING DEMONSTRATED STABILITY THROUGH RANGE OF MOTION WITH NO VARUS OR VALGUS LAXITY AND APPROPRIATE PATELLAR TRACKING. THE WOUND WAS CLOSED AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 24604764 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  AN ADVERSE EVENT WAS REPORTED INVOLVING AN UNKNOWN AESCULAP AG KNEE IMPLANT SYSTEM. SPECIFICALLY, IT WAS REPORTED THAT THERE WAS POSTOPERATIVE LOOSENING. A REVISION SURGERY HAD BEEN PLANNED. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24571063 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  The patient underwent revision left total knee arthroplasty on 22-Dec-2025 due to a loose total knee arthroplasty with gross instability.During revision surgery, the surgeon documented gross loosening of both the femoral and tibial components of the implanted Aesculap Vega knee system. The surgeon noted that the cement had completely debonded from both the femoral and tibial implants. The debonding was so pronounced that the implant imprints remained visible in the intact cement mantle following implant removal.The surgeon reported that the femoral component was grossly loose and could be removed with a periosteal elevator. The tibial component was also grossly loose and was easily removed with a periosteal elevator. The patellar button was additionally found to be loose and was removed. The event required revision total knee arthroplasty involving femoral and tibial component revision and patellar button removal. No intraoperative complications were reported. Patient was transferred to PACU in stable condition following revision surgery.The adverse event is filed under AIS reference XC 100041741 CC 400749557

  Patient problems: Failure of Implant

  MAUDE report 24567959 ↗
• InjuryNov 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED POST-OPERATIVE LOOSENING FOLLOWING A LEFT KNEE ARTHROPLASTY PROCEDURE THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED ON (B)(6) 2018, THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY FOR DEGENERATIVE JOINT DISEASE (DJD). THE PROCEDURE WAS PERFORMED USING CEMENTED COMPONENTS, AND THE OPERATIVE REPORT INDICATES THAT THE IMPLANTS WERE PLACED WITH APPROPRIATE ALIGNMENT AND STABILITY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO FAILED PRIOR KNEE PROSTHESIS WITH LOOSENING OF COMPONENTS. INTRAOPERATIVELY, THE TIBIAL AND FEMORAL COMPONENTS WERE NOTED TO BE LOOSE AND WERE REMOVED WITHOUT DIFFICULTY. REVISION COMPONENTS WERE IMPLANTED USING BONE CEMENT, AND TRIALING DEMONSTRATED STABILITY THROUGH RANGE OF MOTION WITHOUT VARUS OR VALGUS LAXITY. THE OPERATIVE REPORT INDICATES THAT THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION AND NO INTRAOPERATIVE COMPLI

  Patient problems: Failure of Implant

  MAUDE report 23544715 ↗
• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED WITH MECHANICAL LOOSENING OF A PRIOR TOTAL KNEE ARTHROPLASTY. ON (B)(6), 2025, THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE RIGHT KNEE FOR LOOSENING OF PRIOR COMPONENTS. INTRAOPERATIVELY, BOTH THE TIBIAL AND FEMORAL IMPLANTS WERE FOUND TO BE LOOSE WITH EVIDENCE OF CEMENT DEBONDING. ONLY 5-10% OF THE SURFACE HAD RESIDUAL CEMENT ADHESION. THE FEMORAL COMPONENT WAS REMOVED WITH MINIMAL EFFORT USING GENTLE TAPS, AND THE TIBIAL IMPLANT WAS ALSO EASILY REMOVED, CONSISTENT WITH FAILURE OF FIXATION AT THE CEMENT INTERFACE. THE FEMUR AND TIBIA WERE THEN RE-PREPARED. AN INTRAMEDULLARY GUIDE WAS PLACED, AND TRIALING CONFIRMED ALIGNMENT AND STABILITY. FINAL COMPONENTS WERE IMPLANTED USING THIRD-GENERATION VACUUM-MIXED BONE CEMENT WITH DIGITAL IMPACTION. A POLYETHYLENE INSERT WAS PLACED, AND STABILITY WAS CONFIRMED WITH VARUS/VALGUS AND FULL RANGE OF MOTION TESTING. VANCOMYCIN POWDER WAS APPLIED, THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS, AND A STERILE DRESSING WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE AND WAS TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 22994370 ↗