AS VEGA System® PS NX055ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04046963810450), received between Apr 4, 2018 and Jun 9, 2026 — classified as 25 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (17 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• 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 100042032 CC 400760780.

  Patient problems: Failure of Implant

  MAUDE report 25443845 ↗
• InjuryMar 20, 2026Patient-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 (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 (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 COMPLICATION

  Patient problems: Failure of Implant

  MAUDE report 24649236 ↗
• InjuryNov 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT THE KNEE IMPLANT WAS DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 23535570 ↗
• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE RIGHT KNEE FOR LOOSENING OF PRIOR COMPONENTS. A MIDLINE INCISION AND MEDIAL PARAPATELLAR APPROACH WERE PERFORMED, AND THE FEMORAL AND TIBIAL BONE WERE PREPARED USING STANDARD INSTRUMENTS. THE FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED USING THIRD-GENERATION CEMENT TECHNIQUE (VACUUM SEALED). A TIBIAL TRAY AND POLYETHYLENE INSERT WERE PLACED, FOLLOWED BY PATELLAR BUTTON PLACEMENT. DURING THE PROCEDURE, BONE CUTS, TRAILING, AND IMPLANTATION PROCEEDED AS EXPECTED WITH NO REPORTED INTRAOPERATIVE COMPLICATIONS. FINAL INSPECTION CONFIRMED APPROPRIATE FIT AND STABILITY OF THE COMPONENTS, WITH NO EVIDENCE OF MALALIGNMENT OR IMPROPER FIXATION. THE PATIENT TOLERATED THE PROCEDURE, WAS AWAKENED FROM ANESTHESIA, AND TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 22993252 ↗
• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  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.

  Patient problems: Failure of Implant

  MAUDE report 22992549 ↗
• InjuryJul 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT A AS VEGA PS TIBIAL PLATEAU CEMENTED T3 (PART # NX055Z) WAS IMPLANTED ON (B)(6) 2019. 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. THE PATIENT WAS REVISED TO A PRODUCT FROM A DIFFERENT MANUFACTURER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 22518923 ↗
• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INVESTIGATION COMPLETE.

  Patient problems: Failure of Implant

  MAUDE report 16207520 ↗
• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS VEGA PS TIBIAL PLATEAU CEMENTED T3 (ITEM NX055Z) WAS IMPLANTED DURING A LEFT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ASEPTIC LOOSENING OF AESCULAP VEGA CEMENTED TOTAL KNEE REPLACEMENT WITH-DE-BONDING OF THE IMPLANT FROM THE CEMENT MANTLE. THE PATIENT UNDERWENT A REVISION PROCEDURE PROCEDURE ON (B)(6) 2022. 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 SURGERY. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATE MEDWATCH REPORTS: 400582824_2916714-2023-00006_MDR, 400582825_2916714-2023-00007_MDR, 400582827_2916714-2023-00009_MDR, 400582828_2916714-2023-00010_MDR.

  Patient problems: Failure of Implant

  MAUDE report 16206243 ↗
• InjuryJan 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE ADVERSE EVEN IS FILED UNDER AAG REFERENCE (B)(4),((B)(6)). ASSOCIATED MEDWATCH-REPORTS: (B)(6) (9610612-2022-00391) - NX013Z, (B)(6) (9610612-2022-00390) - NX055Z. INVOLVED COMPONENTS: (B)(6)- NN260P - PLUG F/TIBIAL PLATEAU - LOT 51917990, (B)(6)- NX044 - PATELLA 3-PEGS P4 - LOT 51849212, (B)(6)- NX131 - VEGA PS GLIDING SURFACE T3/3+ 12MM - LOT 51872457.

  Patient problems: Insufficient Information

  MAUDE report 16199759 ↗
• InjuryJan 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ASSOCIATED MEDWATCH-REPORTS: 400582818 (9610612-2022-00392) - NX055Z, 400582821 (9610612-2022-00393) - NX033Z. INVOLVED COMPONENTS: 400582819 - NX044 - PATELLA 3-PEGS P4 LOT 51849212. 400582820 - NX132 - VEGA PS GLIDING SURFACE T3/3+ 14MM - LOT 51901306. 400582822 - NN260P - PLUG F/TIBIAL PLATEAU - LOT 51910799.

  Patient problems: Insufficient Information

  MAUDE report 16198914 ↗
• InjuryAug 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 NX055Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T3. ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT LOOSENED POST SURGERY. A PATIENT'S RIGHT TOTAL KNEE WAS BEING REVISED FOR A LOOSE TIBIAL COMPONENT. UPON EXPOSURE IT WAS DETERMINED THAT BOTH THE FEMUR & TIBIAL COMPONENT HAD DEBONDED FROM THE BONE CEMENT ON BOTH COMPONENTS. A TEMPORARY SPACER WAS INSERTED UNTIL IT COULD BE DETERMINED THAT THIS JOINT WAS NOT INFECTED. THE PATIENT IS CURRENTLY SCHEDULED FOR RE-IMPLANTATION OF HIS RIGHT KNEE ON (B)(6) 2021. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX031Z - AS VEGA PS FEMORAL COMP. CEMENTED F5N R - LOT 52360163.

  Patient problems: Failure of Implant

  MAUDE report 12282015 ↗
• InjuryAug 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 NX055Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T3. ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT LOOSENED POST SURGERY. A PATIENT'S RIGHT TOTAL KNEE WAS BEING REVISED FOR A LOOSE TIBIAL COMPONENT. UPON EXPOSURE IT WAS DETERMINED THAT BOTH THE FEMUR & TIBIAL COMPONENT HAD DEBONDED FROM THE BONE CEMENT ON BOTH COMPONENTS. A TEMPORARY SPACER WAS INSERTED UNTIL IT COULD BE DETERMINED THAT THIS JOINT WAS NOT INFECTED. THE PATIENT IS CURRENTLY SCHEDULED FOR RE-IMPLANTATION OF HIS RIGHT KNEE ON (B)(6) 2021. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX031Z - AS VEGA PS FEMORAL COMP.CEMENTED F5N R - LOT 52360163.

  Patient problems: Failure of Implant

  MAUDE report 12281962 ↗
• InjuryMar 4, 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 NX055Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T3. IT WAS REPORTED ON (B)(6) 2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A LEFT KNEE REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013(LEFT), (B)(6) 2013(RIGHT) AND THE REVISION SURGERY OCCURRED ON (B)(6) 2015 LEFT KNEE. 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: NX013Z (PS FEMUR CEMENTED F6N LT), NN260P (PEEK PLUG F/ TIBIA), NX044 (UNIVERSAL PATELLA P4), NX130 (PS PE INSERT T3/T3+, 10MM).

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

  MAUDE report 11416403 ↗
• InjuryMar 4, 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) 2013(LEFT) (B)(6) 2013(RIGHT). ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A LEFT KNEE REVISION SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2015 LEFT KNEE. 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: NX013Z (PS FEMUR CEMENTED F6N LT); NX055Z (PS TIBIA CEMENTED T3); NN260P (PEEK PLUG F/ TIBIA); NX044 (UNIVERSAL PATELLA P4); NX130 (PS PE INSERT T3/T3+, 10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00355, 2916714-2020-00357, 2916714-2020-00358, 2916714-2020-00359.

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

  MAUDE report 11415098 ↗
• InjuryFeb 18, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE CUSTOMER REPORTED THAT THEIR G9 IS NOT SHOWING ANY CARDIAC OUTPUT, CONTINUOUS CARDIAC INDEX, AS WELL AS THE SVR READINGS.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11342450 ↗
• 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 NX055Z-AS VEGA PS TIBIAL PLATEAU CEMENTED T3 IT WAS REPORTED ON (B)(6) 2019 THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN RIGHT KNEE, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. A SUBSEQUENT X-RAY SHOWED POSSIBLE LOOSENING OF THE TIBIAL COMPONENT AND A RADIOLUCENT LINE AROUND THE TIBIAL COMPONENT. BONE SCANS SHOWED AN INCREASED UPTAKE IN THE TIBIAL COMPONENT. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE A WELL-FIXED PATELLAR COMPONENT AND 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. INVOLVED COMPONENTS: NX031Z (PS FEMUR CEMENTED F5N RT), NX043 (UNIVERSAL PATELLA P3), NX130 (PS PE INSERT T3/T3+, 10MM), NN260P (PEEK PLUG F/ TIBIA). THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11164565 ↗
• 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 AS VEGA KNEE, RIGHT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING; AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION OCCURRED ON (B)(6) 2016. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS WHICH RESULTED IN THE REVISION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX033Z (PS FEMUR CEMENTED F6N RT), NX044 (UNIVERSAL PATELLA P4), NX055Z (PS TIBIA CEMENTED T3), NX132 (PS PE INSERT T3/T3+, 14MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00511, 2916714-2020-00512, 2916714-2020-00513, 2916714-2020-00514, 2916714-2020-00515.

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

  MAUDE report 11118499 ↗
• 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 AS VEGA KNEE, LEFT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING; AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION OCCURRED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS WHICH RESULTED IN THE REVISION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX013Z (PS FEMUR CEMENTED F6N LT), NX043 (UNIVERSAL PATELLA P3), NX055Z (PS TIBIA CEMENTED T3), NX131 (PS PE INSERT T3/T3+, 12MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00531, 2916714-2020-00532, 2916714-2020-00534, 2916714-2020-00535.

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

  MAUDE report 11117901 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 LEFT KNEE AND DIFFICULTY WALKING. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015 AND THERE WAS NO REPORTED REVISION SURGERY. 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: NX011Z(PS FEMUR CEMENTED F5N LT), NX043 (UNIVERSAL PATELLA P3), NX055Z (PS TIBIA CEMENTED T3), NX130 (PS PE INSERT T3/T3+, 10MM), NN261Z(TIBIAL OBTURATOR D12MM, L7MM). THE CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00249, 2916714-2020-00250, 2916714-2020-00252, 2916714-2020-00253.

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

  MAUDE report 11014234 ↗
• InjuryDec 15, 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, SWELLING AND LOSS OF MOBILITY WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2015. 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: NX043 (UNIVERSAL PATELLA P3), NX030Z(PS FEMUR CEMENTED F4 RT), NX230 (PS PE INSERT T3/T3+, 10MM), NX055Z (PS TIBIA CEMENTED T3), NX062Z(TIBIAL STEM CEMENTED 12X52MM). THE CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00286, 2916714-2020-00287, 2916714-2020-00288, 2916714-2020-00290.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Swelling/ Edema

  MAUDE report 11012422 ↗
• InjuryDec 8, 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. THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN RIGHT KNEE, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2012, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH HAD RESULTED IN A REVISION SURGERY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX031Z (PS FEMUR CEMENTED F5N RT), NX044 (UNIVERSAL PATELLA P4), NX055Z (PS TIBIA CEMENTED T3), NX130 (PS PE INSERT T3/T3+, 10MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS NOT SPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00631, 2916714-2020-00632, 2916714-2020-00634, 2916714-2020-00635.

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

  MAUDE report 10969834 ↗
• 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 TIBIA OBTURATOR (PART # NN264Z) (REF. ASSOCIATED MDR ID 2916714-2020-00589), COLUMBUS PATELLA SIZE P4 (PART # NN484) (REF. ASSOCIATED MDR ID 2916714-2020-00590), VEGA SYSTEM PS FEMUR F6N R (PART #NX033Z) (REF. ASSOCIATED MDR ID 2916714-2020-00591), VEGA SYSTEM PS TIBIA PLATEAU T3+, CEMENTED IMPLANT (PART # NX056Z), AND A VEGA SYSTEM PS GLIDING SURFACE IMPLANT 12MM T3/T3+ (PART # NX131) (REF. ASSOCIATED MDR ID 2916714-2020-00593), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED KNEE PAIN (MOSTLY LOCATED ON THE INSIDE OF THE KNEE JOINT), WEAKNESS IN RIGHT KNEE, AND DIFFICULTY WITH CLIMBING STAIRS AND RISING FROM A SEATED POSITION. A SUBSEQUENT X-RAY SHOWED LOOSENING OF THE TIBIAL IMPLANT, WHICH RESULTED IN A REVISION SURGERY PERFORMED ON (B)(6)2017. POST-REPLACEMENT SURGERY FINDINGS SHOWED 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.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10823648 ↗
• InjuryNov 10, 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 2916714-2020-00521), VEGA SYSTEM PATELLA 3-PEG SIZE P3 (PART # NX043) (REF. ASSOCIATED MDR ID 2916714-2020-00522), VEGA SYSTEM PS TIBIA PLATEAU T3, CEMENTED IMPLANT (PART # NX055Z), PS+ GLIDING SURFACE IMPLANT 10MM T3/T3+ (PART # NX130) (REF. ASSOCIATED MDR ID 2916714-2020-00524), AND A VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P) (REF. ASSOCIATED MDR ID 2916714-2020-00525), 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 RIGHT KNEE, WHICH RESTRICTED ROUTINE DAILY ACTIVITIES. A SUBSEQUENT X-RAY SHOWED POSSIBLE LOOSENING OF THE TIBIAL COMPONENT AND A RADIOLUCENT LINE AROUND THE TIBIAL COMPONENT. BONE SCANS SHOWED AN INCREASED UPTAKE IN THE TIBIAL COMPONENT. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE A WELL-FIXED PATELLAR COMPONENT AND LOSING OF THE TIBIAL AND FEMORAL COMPONENTS. THE CEMENT USED DURING THE PRIMARY SURGERY WAS IDENTIFIED AS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. TH

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10815755 ↗
• InjuryNov 9, 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 VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN LEFT KNEE AND NORMAL DAILY ACTIVITIES WAS RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE A WELL-FIXED PATELLAR COMPONENT AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH RESULTED IN REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2016. CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. 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: NX013Z (PS FEMUR CEMENTED F6N LT), NX043 (UNIVERSAL PATELLA P3), NX055Z (PS TIBIA CEMENTED T3), NX131(PS PE INSERT T3/T3+,12MM), NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00555, 2916714-2020-00556, 2916714-2020-00558, 2916714-2020-00559.

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

  MAUDE report 10809750 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA KNEE IMPLANT SYSTEM, COMPRISED OF THE FOLLOWING COMPONENTS, VEGA SYSTEM PS TIBIA PLATEAU T3, CEMENTED IMPLANT (PART # NX055Z), VEGA SYSTEM PS FEMUR F6N L (PART #NX013Z) (REF. ASSOCIATED MDR ID 2916714-2020-00527), VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P) (REF. ASSOCIATED MDR ID 2916714-2020-00528), PS+ GLIDING SURFACE IMPLANT 12MM T3/T3+ (PART # NX131) (REF. ASSOCIATED MDR ID 2916714-2020-00529), AND A PATELLA 3-PEG P2 (PART # NX044) (REF. ASSOCIATED MDR ID 2916714-2020-00530), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED KNEE PAIN, SWELLING, AND DIFFICULTY WALKING. THERE WAS NO REPORTED REVISION SURGERY. THE CEMENT USED DURING THE PRIMARY SURGERY IS UNKNOWN. 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: NX055Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T3 - LOT # 51904336, NX013Z - AS VEGA PS FEMORAL COMP.CEMENTED F6N L - LOT #

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10804432 ↗