AS NR184ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963176396), received between Feb 16, 2021 and Feb 16, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2021Patient-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Patient-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH COLUMBUS KNEE IMPLANT(S). ACCORDING TO THE COMPLAINT, THE PATIENT FELL OFF A LADDER AND THE IMPLANTS MAY BE REVISED IN THE FUTURE; THE PATIENT IS BEING FOLLOWED BY A PHYSICIAN FOR ANY FURTHER TREATMENT. THE INTIAL IMPLANTATION WAS PERFORMED ON (B)(6) 2018 AND THE REVISION WAS NOT YET PLANNED OR SCHEDULED. HE FELL OFF 16 FOOT LADDER. THERE IS NOW LOOSENING AT MEDIAL TIBIA WITH SEVERE BONE SPLINTER PAIN 3 INCHES DOWN, MEDIAL WITH PAD SCUFFING - FLOATER IS PRESENT. JOINT IS TOO TIGHT, HOWEVER, MAXIMUM BEND IS AT ACCEPTABLE RANGE ACCORDING TO CURRENT TREATING DOCTOR. TIBIA NOW REPORTEDLY HAS OSTEOPOROSIS. SHARP PAIN BOTH ANTERIOR HORIZONTAL PLANT OF PATELLA; PERHAPS SMALLER THICKNESS PAD REPLACEMENT WOULD FIX PRESSURE PROBLEM. PATIENT IS EXTREMELY BOW-LEGGED, SO LONG STEM IS TORQUEING TIBIA WITH BONE PAIN. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER XC REFERENCE (B)(4). CONCOMITANT PRODUCTS: NR142M KIR # 52098006, NR466Z LOT # 52091106, NR077Z LOT # 52259916, NR436Z LOT # 52166188, NR006Z LOT # 52184799, NR400Z LOT # 52337135.

  Patient problems: Fall; Pain

  MAUDE report 11334224 ↗