VEGA System PSRecalls & reported problems across all models

We found 31 models of VEGA System PS by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 96 adverse event reports in the FDA's MAUDE database, received between Sep 15, 2020 and Aug 17, 2026 — classified as 95 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (46 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VEGA System PS problems

VEGA System PS models

31 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VEGA System® PS+ NX230

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  10 reports
• VEGA System® PS+ NX220

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  9 reports
• VEGA System® PS NX130

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  8 reports
• VEGA System® PS NX112

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  6 reports
• VEGA System® PS NX131

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  6 reports
• VEGA System® PS NX120

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• VEGA System® PS NX121

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• VEGA System® PS+ NX210

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• VEGA System® PS+ NX221

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  4 reports
• VEGA System® PS+ NX240

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  4 reports
• VEGA System® PS NX100

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• VEGA System® PS NX110

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• VEGA System® PS NX132

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• VEGA System® PS NX140

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• VEGA System® PS+ NX222

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• VEGA System® PS NX051K

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• VEGA System® PS NX102

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• VEGA System® PS+ NX211

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• VEGA System® PS NX031K

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA System® PS NX101

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA System® PS NX103

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA System® PS NX123

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA System® PS NX144

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA System® PS NX150

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA System® PS NX152

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA System® PS+ NX200

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA System® PS+ NX214

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA System® PS+ NX223

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA System® PS+ NX250

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VEGA SYSTEM PS NS824R

  TEMPLATE
  1 report
• VEGA System® PS NX353

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report

Recent VEGA System PS adverse event reports

The 15 most recent reports across all models, 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 50275307 ↗
• 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 50260855 ↗
• 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 repement with the patella resurfaced. The femoral component appeared loose, with severe periprosthetic osteolysis about the femur. The patient was assessed with mechanical loosening and periprosthe

  Patient problems: Insufficient Information

  MAUDE report 50260354 ↗
• InjuryAug 14, 2026Patient-Device Incompatibility

  An outside law firm reported that a patient experienced loosening of the left knee prosthesis. According to the available medical records, the patient underwent a left total knee arthroplasty on (b)(6) 2022, for left knee osteoarthritis. The procedure utilized an Aesculap Vega system. The operative report documented that the procedure was completed without reported intraoperative complications. Intraoperative trialing demonstrated full extension and flexion with appropriate patellar tracking. The implants were placed using third-generation cement technique, and the patient was taken to the post-anesthesia care unit in stable condition. On (b)(6) 2026, the patient was evaluated for left knee pain. The assessment included mechanical loosening of the internal left knee prosthetic joint. A triple-phase bone scan was reported as normal with no prosthetic loosening, fracture, or osteomyelitis; however, the treating physician documented disagreement with the radiology interpretation, noting increased uptake along the patellar component and underneath the femoral component. The patient was reportedly tender in this area, and the physician documented that the findings were consistent with l

  Patient problems: Insufficient Information

  MAUDE report 50258557 ↗
• InjuryJun 30, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ISSUES WITH A LEFT KNEE PROSTHESIS. ACCORDING TO THE OPERATIVE REPORT, A PATIENT WITH A HISTORY OF BILATERAL KNEE DEGENERATIVE JOINT DISEASE AND PRIOR TOTAL KNEE ARTHROPLASTIES PRESENTED WITH ONGOING MUSCULOSKELETAL COMPLAINTS. THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2021 WITHOUT INTRAOPERATIVE COMPLICATIONS. SUBSEQUENTLY, AFTER A MOTOR VEHICLE ACCIDENT IN (B)(6) 2022, THE PATIENT REPORTED NECK, BACK, HIP, AND LEFT KNEE PAIN. IMAGING AT THAT TIME DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH NORMAL ALIGNMENT AND NO EVIDENCE OF LOOSENING OR INSTABILITY. ACCORDING TO THE MEDICAL RECORDS, FOLLOWING THE ACCIDENT, THE PATIENT REPORTED PERSISTENT LEFT LOWER EXTREMITY PAIN WITH RADIATION IN AN S1 DISTRIBUTION, NUMBNESS, AND ONGOING DISCOMFORT. AN ORTHOPEDIC EVALUATION DATED (B)(6) 2022, DOCUMENTED PAIN AND DISCOMFORT INVOLVING THE LEFT LEG IN THE S1 DISTRIBUTION. PHYSICAL EXAMINATION DEMONSTRATED A POSITIVE STRAIGHT LEG RAISE ON THE LEFT AT 45 DEGREES WITH DECREASED SENSATION OVER THE LATERAL THREE TOES. AT THIS TIME, THE PATIENT HAS NOT BEEN SCHEDULED TO UNDERGO A REVISION PROCEDURE. THE EVENT

  Patient problems: External Prosthetic Device Pain

  MAUDE report 25668988 ↗
• InjuryJun 25, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED POSTOPERATIVE LOOSENING FOLLOWING A RIGHT TOTAL KNEE ARTHROPLASTY. ACCORDING TO THE AVAILABLE OPERATIVE REPORT, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022, FOR RIGHT KNEE TRICOMPARTMENTAL OSTEOARTHRITIS. THE PROCEDURE UTILIZED AESCULAP COMPONENTS WHICH WERE CEMENTED USING PALACOS BONE CEMENT. THE OPERATIVE REPORT DOCUMENTED THAT THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INTRAOPERATIVE COMPLICATIONS. TRIALING AND FINAL IMPLANTATION DEMONSTRATED FULL EXTENSION AND FLEXION, NO INSTABILITY, AND SATISFACTORY PATELLAR TRACKING. THE PATIENT WAS TAKEN TO RECOVERY IN GOOD CONDITION. THE OPERATIVE REPORT DID NOT DOCUMENT INTRAOPERATIVE EVIDENCE OF LOOSENING, DEVICE MALFUNCTION, OR OTHER DEVICE-RELATED COMPLICATIONS AT THE TIME OF THE INDEX PROCEDURE. A CLINIC NOTE DATED (B)(6) 2022 INDICATED THAT THE PATIENT'S RANGE OF MOTION WAS BACK TO 95 OR 100 BUT STATED THAT THE PATIENT STILL WALKED WITH A LIMP. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25621038 ↗
• 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 (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25484829 ↗
• InjuryJun 9, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING RIGHT KNEE PAIN AND INSTABILITY FOLLOWING A RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT HAD A HISTORY OF END-STAGE DEGENERATIVE ARTHRITIS OF THE RIGHT KNEE AND UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020. FOLLOWING SURGERY, THE PATIENT CONTINUED TO REPORT PAIN, SWELLING, AND INSTABILITY. A CLINIC VISIT ON (B)(6) 2021, DOCUMENTED CONTINUED KNEE SWELLING AND LATERAL PATELLAR TRACKING. SUBSEQUENT EVALUATION NOTED A WELL-HEALED INCISION, RANGE OF MOTION FROM 0 TO 110 DEGREES, AND MID-FLEXION INSTABILITY WITH VARUS/VALGUS LAXITY. RADIOGRAPHS REPORTEDLY DEMONSTRATED A WELL-ALIGNED PROSTHESIS WITHOUT EVIDENCE OF LOOSENING, FRACTURE, OR MECHANICAL FAILURE. DUE TO PERSISTENT PAIN AND INSTABILITY, THE PATIENT UNDERWENT REVISION RIGHT TOTAL KNEE ARTHROPLASTY INVOLVING POLYETHYLENE EXCHANGE ON (B)(6) 2021. INTRAOPERATIVE FINDINGS INCLUDED SIGNIFICANT MEDIAL-LATERAL INSTABILITY, CREPITATION, SYNOVIAL SWELLING, AND CLEAR JOINT FLUID WITHOUT EVIDENCE OF INFECTION. THE EXISTING POLYETHYLENE INSERT WAS REMOVED AND REPLACED WITH A SIZE 14 AESCULAP POSTERIOR-STABILIZED POLYETHYLENE INSERT. SYNOVECTOMY, DEBRIDEMENT, AND REMOVA

  Patient problems: Failure of Implant

  MAUDE report 25448581 ↗
• InjuryJun 9, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES INVOLVING A RIGHT KNEE PROSTHESIS. ACCORDING TO OPERATIVE RECORDS, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022, FOR AVASCULAR NECROSIS (AVN) OF THE LATERAL TIBIAL PLATEAU. THE PROCEDURE UTILIZED AESCULAP VEGA COMPONENTS WHICH WERE CEMENTED USING PALACOS CEMENT. THE OPERATIVE REPORT INDICATED THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INTRAOPERATIVE COMPLICATIONS, AND THE KNEE DEMONSTRATED FULL EXTENSION AND FLEXION WITH CENTRAL PATELLAR TRACKING AT THE CONCLUSION OF SURGERY. AT A FOLLOW-UP VISIT ON (B)(6) 2023, THE PATIENT REPORTED CONTINUED PAIN AND DISCOMFORT, AS WELL AS WEAKNESS INVOLVING THE QUADRICEPS. RADIOGRAPHS OF THE KNEE WERE OBTAINED, AND QUADRICEPS WEAKNESS WAS NOTED ON EXAMINATION. AT A SUBSEQUENT FOLLOW-UP ON OCTOBER 22, 2024, THE PATIENT REPORTED PAIN AND DISCOMFORT INVOLVING THE RIGHT KNEE. PHYSICAL EXAMINATION DOCUMENTED INSTABILITY OF THE KNEE JOINT, AND THE PATIENT REPORTED FALLS AND FUNCTIONAL DIFFICULTIES. REVISION SURGERY WAS DISCUSSED. DURING A FOLLOW-UP VISIT ON (B)(6) 2025, THE PATIENT CONTINUED TO REPORT INSTABILITY AND RECURRENT FALLS. EXAMINATION DOCUMENTED

  Patient problems: Failure of Implant

  MAUDE report 25448579 ↗
• InjuryJun 9, 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. THIS REPORT IS FILED UNDER AIS REFERENCE XC (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25443800 ↗
• InjuryJun 8, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS WITH AN AESCULAP KNEE IMPLANT. REPORTEDLY THE FEMORAL COMPONENT WAS "GROSSLY LOOSE" AND "REMOVED BY HAND". THE TIBIAL COMPONENT WAS ALSO "GROSSLY LOOSE" AND "LIFTED OUT OF THE CEMENT MANTLE" THE CEMENT MANTLE REMAINED ADHERED TO THE BONES AND HAD TO BE EXTRACTED DURING THE REVISION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25431191 ↗
• InjuryMay 19, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED POSTOPERATIVE LOOSENING. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT, WITH A HISTORY OF RIGHT KNEE DEGENERATIVE JOINT DISEASE, UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2022. THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. A SUBSEQUENT CLINIC NOTE DATED (B)(6) 2025 INDICATES THAT THE PATIENT CONTINUED TO EXPERIENCE SYMPTOMS AND WOULD LIKELY REQUIRE FURTHER KNEE REPLACEMENT INTERVENTION. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25217829 ↗
• 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 (B)(6), 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 (B)(6) 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 INCLUDED MEC

  Patient problems: Failure of Implant

  MAUDE report 24999167 ↗
• 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 24998744 ↗
• 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 (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24998405 ↗

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