Columbus® NN484Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653352609), received between Nov 9, 2020 and Nov 11, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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), 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 SUBSEUQENT 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 10823641 ↗
• 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: 2916714-2020-00584. 2916714-2020-00585. 2916714-2020-00586. 2916714-2020-00587.

  Patient problems: Pain

  MAUDE report 10813507 ↗