AS NN264ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046963124519), received between Sep 29, 2020 and Sep 8, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE LEFT KNEE FOR LOOSENING OF PRIOR COMPONENTS. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION KNEE SURGERY FOR A LOOSE PATELLAR BUTTON. THE PATELLAR BUTTON WAS REMOVED EASILY WITH A RONGEUR AND OSTEOTOME. A NEW PATELLAR BUTTON WAS NOT IMPLANTED DUE TO INADEQUATE BONE STOCK AND RISK OF LOOSENING. THE FEMORAL AND TIBIAL COMPONENTS WERE ASSESSED AND APPEARED STABLE. THE JOINT WAS IRRIGATED, VANCOMYCIN POWDER WAS PLACED INTRA-ARTICULARLY, AND THE CAPSULE WAS CLOSED. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION. ON (B)(6) 2024, THE PATIENT RETURNED WITH EVIDENCE OF FEMORAL AND TIBIAL COMPONENT LOOSENING. A MIDLINE INCISION AND MEDIAL PARAPATELLAR APPROACH WERE USED. THE TIBIAL COMPONENT WAS REMOVED AFTER CEMENT AT THE BONE INTERFACE WAS DISRUPTED AND THE IMPLANT WAS KNOCKED FREE. THE FEMORAL COMPONENT WAS THEN REMOVED WITH USE OF A SAW AND OSTEOTOME AFTER CIRCUMFERENTIAL RELEASE. APPROXIMATELY ONE-THIRD OF THE FEMUR WAS LOST DURING REMOVAL. AN ANTIBIOTIC-IMPREGNATED SPACER WAS IMPLANTED, AND THE JOINT WAS CLOSED FOLLOWING IRRIGATION AND VANCOMYCIN POWDER APPLICATION. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE COND

  Patient problems: Failure of Implant

  MAUDE report 22993984 ↗
• InjuryAug 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE RIGHT KNEE FOR LOOSENING AND FAILURE OF PRIOR COMPONENTS. THE FEMORAL COMPONENT WAS REMOVED WITH MICRO-OSTEOTOME TECHNIQUES. THE TIBIA DEMONSTRATED MEDIAL-SIDED COLLAPSE AND WAS REAMED/BROACHED TO APPROPRIATE SIZE. TRIAL COMPONENTS WERE PLACED, AND STABLE FIXATION WITH ACCEPTABLE FLEXION/EXTENSION WAS ACHIEVED. FINAL FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED USING THIRD-GENERATION CEMENT TECHNIQUE. 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 22903733 ↗
• InjuryJul 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS TIBIAL OBTURATOR D14MM (PART # NN264Z) 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 22518925 ↗
• InjuryMar 25, 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 AN AESCULAP PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN AND LOOSENING OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, WHICH INCLUDED NON-AESCULAP IMPLANTS. A REVISION TO REPLACE NON-AESCULAP PRODUCTS WITH AESCULAP IMPLANTS OCCURRED ON (B)(6) 2017, AND THERE WAS NO REPORTED SECOND 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); NX059Z (PS TIBIA CEMENTED T5); NX152 (PS PE INSERT T5, 14MM); NN264Z (TIBIAL OBTURATOR D14MM, L7MM). ASSOCIATED MEDWATCHES: 2916714-2020-00396, 2916714-2020-00397, 2916714-2020-00398, 2916714-2020-00399.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 11568876 ↗
• InjuryMar 5, 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 PAIN SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT. AFTER FIRST REVISION SURGERY, PATIENT CONTINUED TO EXPERIENCE PAIN, SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A SECOND REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, WITH FIRST REVISION IN (B)(6) 2015, WITH ANOTHER VEGA IMPLANT. THE SECOND REVISION SURGERY OCCURRED ON (B)(6) 2017, WITH AN UNIDENTIFIED NON-AESCULAP IMPLANT.. 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: NX030Z (PS FEMUR CEMENTED F4 RT) NN264Z (TIBIAL OBTURATOR D14MM, L7MM) NX043 (UNIVERSAL PATELLA P3) NX056Z (PS TIBIA CEMENTED T3+) NX132 (PS PE INSERT T3/T3+, 14MM) THE COMPONENTS LISTED ARE RELATED TO THE PRIMARY SURGERY. IT IS UNKNOWN EXACTLY WHICH COMPONENTS WERE REPLACED IN THE FIRST AND SECOND REVISION S

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

  MAUDE report 11423435 ↗
• 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), 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) (REF. ASSOCIATED MDR ID 2916714-2020-00592), 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 10823637 ↗
• 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 A VEGA KNEE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN AND INSTABILITY. THE PATIENT CLAIMED TO HAVE BEEN ABLE TO HEAR "RATTLING" SOUNDS POSTOPERATIVELY; RESULTS OF X-RAYS SHOWED LOOSENING OF THE IMPLANT. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2015, AND THE REVISION WAS PERFORMED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS WERE LOOSENING OF THE TIBIAL KEEL AND FEMORAL COMPONENT. SURGICAL CEMENT CONTINUED TO ADHERE TO THE BONE BUT HAD NOT ADHERED TO THE IMPLANT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NN484 (COLUMBUS PRI/REV PE PATELLA 3-PEGS P4). NX058Z (PS TIBIA CEMENTED T4+). NX140 (PS PE INSERT T4/T4+, 10MM). NN264Z (TIBIAL OBTURATOR D14MM, L7MM). NX034Z (PS FEMUR CEMENTED F6 RT). THE CEMENT USED WAS NOT SPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00583. 2916714-2020-00584. 2916714-2020-00585. 2916714-2020-00587.

  Patient problems: Pain

  MAUDE report 10813522 ↗
• 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 KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2017 AND THERE WAS NO REPORTED REVISION SURGERY. CEMENT USED: DEPURY SMARTSET GHV 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: NN264Z (TIBIAL OBTURATOR D14MM L7MM). NX057Z (PS TIBIA CEMENTED T4). NX033Z (PS FEMUR CEMENTED F6N RT). NX240(PS+PE INSERT T4/T4+,10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00565. 2916714-2020-00567. 2916714-2020-00568.

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

  MAUDE report 10812075 ↗
• InjuryOct 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 COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2016 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 / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX042 (UNIVERSAL PATELLA P2). NX033Z(PS FEMUR CEMENTED F6N RT). NN264Z(TIBIAL OBTURATOR D14MM, L7MM). NX056Z(PS TIBIA CEMENTED T3+). NX130 (PS PE INSERT T3/T3+, 10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00476. 2916714-2020-00477. 2916714-2020-00479. 2916714-2020-00480.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10653265 ↗
• InjurySep 29, 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. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2014 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 / MALFUNCTION IS FILED UNDER REFERENCE XC 100026129. ASSOCIATED MEDWATCHES: 2916714-2020-00378, 2916714-2020-00379, 2916714-2020-00381, 2916714-2020-00382. INVOLVED COMPONENTS: NX033Z (PS FEMUR CEMENTED F6N RT), NX057Z (PS TIBIA CEMENTED T4), NN264Z (TIBIAL OBTURATOR D14MM, L7MM), NX140 (PS PE INSERT T4/T4+, 10MM), NX043 (UNIVERSAL PATELLA P3). CEMENT: ZIMMER PALACOS R+G RADIOPAQUE BONE CEMENT (00-1113-140-01).

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10601357 ↗