AS VEGA System® PS NX051ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04046963810375), received between May 3, 2018 and Aug 14, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 50260852 ↗
• InjuryMar 10, 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. PATIENTS 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. THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY REVISION ON (b)(6), 2026 AND WAS IMPLANTED WITH ANOTHER MANUFACTURER'S DEVICE. THE EVENT IS FILED UNDER AIS REFERENCE (b)(6)CC (b)(6)

  Patient problems: Failure of Implant

  MAUDE report 24556599 ↗
• 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 TRAILING 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 22994355 ↗
• InjuryJun 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2017, WITH IMPLANTATION OF A VEGA SYSTEM IN THE RIGHT KNEE. THE TIBIAL COMPONENT REPORTEDLY LOOSENED AND REQUIRED REVISION ON (B)(6) 2018, AT WHICH TIME THE VEGA SYSTEM WAS AGAIN USED FOR THE BOTTOM COMPONENT. ON (B)(6) 2019, A SECOND REVISION WAS PERFORMED AFTER THE FEMORAL COMPONENT REPORTEDLY FAILED, AND THE CONSTRUCT WAS REVISED TO A COLUMBUS AF SYSTEM. DESPITE THE REVISIONS, THE PATIENT CONTINUED TO EXPERIENCE INSTABILITY AND PAIN. ON (B)(6) 2022, A THIRD REVISION WAS PERFORMED, AND ALL AESCULAP COMPONENTS WERE REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. WHILE NO FURTHER MECHANICAL FAILURE HAS OCCURRED SINCE THAT SURGERY, THE PATIENT CONTINUES TO REPORT CHRONIC SWELLING, PAIN, AND LIMITED MOBILITY IN THE RIGHT KNEE. THE RIGHT KNEE IS NOW VISIBLY LARGER THAN THE LEFT, AND THE PATIENT REQUIRED A LEFT KNEE REPLACEMENT DUE TO OVERCOMPENSATION. THE EXPLANTED RIGHT KNEE COMPONENTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 22306732 ↗
• InjuryJan 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A AS VEGA PS TIBIAL PLATEAU CEMENTED T1 (PART# NX051Z) WAS IMPLANTED DURING A LEFT TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS WAS OBSERVED. THE PATELLA WAS NOTED AS BEING IN GOOD POSITION WITH NO EVIDENCE OF LOOSENING. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE XC (B)(4). ASSOCIATED MEDWATCH REPORTS: 400582830_2916714-2023-00011_MDR; 400582831_2916714-2023-00012_MDR; 400582833_2916714-2023-00014_MDR; 400582834_2916714-2023-00015_MDR.

  Patient problems: Failure of Implant

  MAUDE report 16216569 ↗
• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPDATE: ONE OF THE INVOLVED COMPONENTS ITEM NUMBER AND NAME CHANGED. (B)(6). THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4) (B)(6). ASSOCIATED MEDWATCH-REPORTS: (B)(6), (9610612-2022-00389) - NX009Z. (B)(6), (9610612-2022-00388) - NX051Z. INVOLVED COMPONENTS: (B)(6) - NN260P - PLUG F/TIBIAL PLATEAU - LOT 51959433. (B)(6) - NX042 - PATELLA 3-PEGS P2 - LOT 51944942. (B)(6) - NX112 - VEGA PS GLIDING SURFACE T1/1+ - LOT 51946472.

  Patient problems: Insufficient Information

  MAUDE report 16207435 ↗
• InjuryMar 19, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED LOOSENING OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION SURGERY OCCURRED ON (B)(6) 2017. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT), NX043 (UNIVERSAL PATELLA P3), NX110 (PS PE INSERT T1/T1+, 10MM), NN260P (PEEK PLUG F/ TIBIA), NX051Z (PS TIBIA CEMENTED T1). THE CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00329, 2916714-2020-00330, 2916714-2020-00331, 2916714-2020-00332, 2916714-2020-00333.

  Patient problems: Joint Laxity

  MAUDE report 11529023 ↗
• InjuryMar 18, 2021Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NX051Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T1. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED LOOSENING OF THE IMPLANT WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2017. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME; IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT), NX043 (UNIVERSAL PATELLA P3), NX110 (PS PE INSERT T1/T1+, 10MM), NN260P (PEEK PLUG F/ TIBIA).

  Patient problems: Implant Pain

  MAUDE report 11517399 ↗
• InjuryJan 28, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA KNEE IMPLANT SYSTEM, COMPRISED OF THE FOLLOWING COMPONENTS, VEGA SYSTEM PS FEMUR F5N R (PART #NX031Z) (REF. ASSOCIATED MDR ID 2916714-2020-00624), VEGA SYSTEM PATELLA 3-PEG SIZE P3 (PART # NX043) (REF. ASSOCIATED MDR ID 2916714-2020-00625), VEGA SYSTEM PS TIBIA PLATEAU T1, CEMENTED IMPLANT (PART # NX051Z), VEGA SYSTEM PS GLIDING SURFACE IMPLANT 14MM T1/T1+ (PART # NX112) (REF. ASSOCIATED MDR ID 2916714-2020-00627), AND A VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P) (REF. ASSOCIATED MDR ID 2916714-2020-00628), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND SWELLING IN IN THE RIGHT KNEE, WHICH RESTRICTED ROUTINE DAILY ACTIVITIES. THE PATIENT UNDERWENT A REVISION SURGERY PERFORMED ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S IMPLANT. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY REVEALED LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS. NO COMPONENTS WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO KNOWN ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE REVISION SURGERY. ADDITIO

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 11248034 ↗
• InjuryJan 13, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NX051Z-AS VEGA PS TIBIAL PLATEAU CEMENTED T1. IT WAS REPORTED ON (B)(6) 2019 THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN BOTH KNEES, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERIES WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. CEMENT USED: PALACOS R RADIOPAQUE BONE CEMENT. INVOLVED COMPONENTS: NX042 (UNIVERSAL PATELLA P2), NX112 (PS PE INSERT T1/T1+, 14MM), NN260P (PEEK PLUG F/ TIBIA). THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE 100026394/400485940. ASSOCIATED MEDWATCH REPORT: 9610612-2020-00558 (NX011Z 400485938), 9610612-2020-00559 (NX051Z 400485940). THE SAME PATIENT HAS AN ADVERSE EVENT / MALFUNCTION FILED UNDER REFERENCE (B)(4) ( RIGHT KNEE).

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Swelling/ Edema

  MAUDE report 11166030 ↗
• InjuryJan 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SWELLING IN THE LEFT KNEE AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE XC (B)(4). INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT), NX042 (UNIVERSAL PATELLA P2), NX051Z (PS TIBIA CEMENTED T1), NX112 (PS PE INSERT T1/T1+, 14MM), NN260P (PEEK PLUG F/ TIBIA). CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. ASSOCIATED MEDWATCHES: 2916714-2020-00619, 2916714-2020-00620, 2916714-2020-00622, 2916714-2020-00623.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11120323 ↗
• InjuryNov 11, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA KNEE IMPLANT SYSTEM, COMPRISED OF THE FOLLOWING COMPONENTS, VEGA SYSTEM PS FEMUR F5N R (PART # NX031Z) (REF. ASSOCIATED MDR ID 2916714-2020-00550), VEGA SYSTEM PATELLA 3-PEG SIZE P2 (PART # NX042) (REF. ASSOCIATED MDR ID 2916714-2020-00551), VEGA SYSTEM PS TIBIA PLATEAU T1, CEMENTED IMPLANT (PART # NX051Z), VEGA SYSTEM PS GLIDING SURFACE IMPLANT 14MM T1/T1+ (PART # NX112) (REF. ASSOCIATED MDR ID 2916714-2020-00553), AND A VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P) (REF. ASSOCIATED MDR ID 2916714-2020-00554), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND SWELLING IN BOTH KNEES, WHICH RESTRICTED ROUTINE DAILY ACTIVITIES. THE PATIENT UNDERWENT A REVISION SURGERY PERFORMED ON MAY 24, 2016. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY REVEALED LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS. THE CEMENT USED DURING THE PRIMARY SURGERY IS UNKNOWN. NO KNOWN ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE REVISION SURGERY. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10826159 ↗
• InjuryNov 6, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN AND SWELLING IN RIGHT KNEE AND NORMAL DAILY ACTIVITIES WAS RESTRICTED DUE TO PAIN. A SUBSEQUENT X-RAY SHOWED POSSIBLE LOOSENING OF THE TIBIAL COMPONENT AND A RADIOLUCENT LINE AROUND THE TIBIAL COMPONENT. DURING REPLACEMENT SURGERY INTRAOPERATIVE FINDINGS WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH RESULTED IN REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURED ON (B)(6) 2016. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX031Z (PS FEMUR CEMENTED F5N RT). NX043 (UNIVERSAL PATELLA P3). NX051Z (PS TIBIA CEMENTED T1). NX112(PS PE INSERT T1/T1+,14MM). NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00516. 2916714-2020-00517. 2916714-2020-00519. 2916714-2020-00520.

  Patient problems: Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 10803571 ↗
• InjuryNov 6, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AS VEGA KNEE, LEFT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED BILATERAL KNEE PAIN AND SWELLING; AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2013, AND THE REVISION WAS PERFORMED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS SHOWED LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX011Z (PS FEMUR CEMENTED F5N LT), NX042 (UNIVERSAL PATELLA P2), NX051Z (PS TIBIA CEMENTED T1), NX112 (PS PE INSERT T1/T1+, 14MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS PALACOS R RADIOPAQUE BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE XC (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00545, 2916714-2020-00546, 2916714-2020-00548, 2916714-2020-00549. THE SAME PATIENT HAS AN ADVERSE EVENT / MALFUNCTION FILED UNDER REFERENCE XC (B)(4) (RIGHT KNEE).

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 10803362 ↗
• InjurySep 15, 2020Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  NO UPDATES.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10535599 ↗
• InjurySep 15, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS VEGA PS TIBIAL PLATEAU CEMENTED T1 DEVICE WAS IMPLANTED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED LOOSENING OF THE AS VEGA KNEE, WHICH RESULTED IN A REVISION SURGERY BEING PERFORMED ON (B)(6) 2019. THE CEMENT USED DURING THE PRIMARY SURGERY IS UNKNOWN. NO KNOWN ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE REVISION SURGERY. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX027Z - AS VEGA PS FEMORAL COMP.CEMENTED F3N R - LOT # UNKNOWN, NX042 - PATELLA 3-PEGS P2 - LOT # UNKNOWN, NX051Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T1 - LOT # UNKNOWN, NX100 - VEGA PS GLIDING SURFACE T0/0+ 10MM - LOT # UNKNOWN, NN260P - PLUG F/TIBIAL PLATEAU - LOT # UNKNOWN.

  Patient problems: Implant Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10535585 ↗
• MalfunctionMay 3, 2018Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth; Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth

  ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT LOOSENED POSTOPERATIVELY AND THE PATIENT HAD SEVERAL REVISION SURGERIES. THE IMPLANTATION WITH VEGA SYSTEM WAS PERFORMED ON MARCH 1, 2017 (RIGHT TOTAL KNEE REPLACEMENT). ON APRIL 10, 2018, THE FIRST REVISION SURGERY WAS PERFORMED AS A RESULT OF ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. AFTERWARDS, IN MARCH 2019, A SECOND REVISION WAS PERFORMED DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE VEGA SYSTEM WAS REPLACED WITH COLUMBUS. A SCAR TISSUE ATTACHED TO THE KNEE CAP, "CLUNK LESION," WAS DISCOVERED IN JANUARY 2021. THE PATIENT HAD TRAUMA FROM THE RIGHT KNEE REPLACEMENT THAT HAS CAUSED STENOSIS IN HER LUMBAR SPINE BILATERAL. PATIENT IS STILL HAVING CONSTANT PAIN IN THE RIGHT LEG, SWELLING, AND DIFFICULTY SLEEPING. ON 26APRIL2022, A THIRD REVISION SURGERY WAS PERFOMED AND THE COLUMBUS SYSTEM WAS REPLACED WITH NON-AESCULAP PRODUCTS. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 7485336 ↗