Columbus® PS NN531Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653352746), received between Apr 1, 2021 and Apr 1, 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.

• InjuryApr 1, 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 KNEE IMPLANT SYSTEM. IT WAS REPORTED ON 26JUL2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2011 AND THE REVISION SURGERY OCCURRED ON (B)(6). 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 (B)(4) REFERENCE (B)(4). INVOLVED COMPONENTS: NN165K (COLUMBUS PS FEMUR SZ 5 LEFT); NN075K (COLUMBUS CR MODULAR TIBIA SZ 3); NN260P (PEEK PLUG F/TIBIA); NN482 (COLUMBUS PRI/REV PE PATELLA 3-PEGS P2); NN531 (COLUMBUS PS TIBIAL INSERT SZ 3/3+ 12MM). CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT THE PRIMARY SURGERY WAS PERFORMED WITHOUT AS TECHNOLOGY. ASSOCIATED MEDWATCHES: 2916714-2020-00370, 2916714-2020-00371, 2916714-2020-00372, 2916714-2020-00373.

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

  MAUDE report 11602338 ↗