AS univation® XF NO163ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964053740), received between Nov 26, 2020 and Nov 26, 2020 — 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.

• InjuryNov 26, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPDATE: (B)(6) 2016 PROCEDURE - LEFT KNEE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY. NORMAL OPERATIVE COURSE. (PALACOS BONE CEMENT). (B)(6) 2017 PREOP DX: FAILED UNICOMPARTMENTAL TOTAL KNEE (PARTIAL KNEE) - NICKEL ALLERGY NOTED. INDICATIONS: SIGNIFICANT STIFFNESS AND PAIN, DEGENERATIVE CHANGES ON THE OTHER SIDE AND PATIENT HAS REQUESTED CONVERSION TO A TOTAL KNEE ARTHROPLASTY. HISTORY: CONSERVATIVE PAIN TREATMENTS HAVE FAILED; STEROID INJECTION IN THE OFFICE WITH TEMPORARY RELIEF; X-RAY RESULTS SHOWED NO OBVIOUS SIGNED OF LOOSENING, WEAR OR FAILURE. PROCEDURE: REVISION OF LEFT KNEE; REMOVAL OF PREVIOUS KNEE IMPLANT WITHOUT SIGNIFICANT BONE LOSS; REPLACED WITH NON-AESCULAP PRODUCTS. (B)(6) 2019 HOSPITAL ADMISSION FOR PROSTHESIS PAIN (IMAGING ORDER DIAGNOSIS - POSSIBLE INFECTION/INFLAMMATORY REACTION DUE TO INTERNAL PROSTHETIC DEVICE, IMPLANT, AND/OR GRAFT) - 2ND BONE SCAN. THE PATIENT IS CURRENTLY UNABLE TO WALK WITHOUT A LIMP AND DOES NOT HAVE FULL MOBILITY OF HER KNEE DUE TO CONTINUOUS SURGERIES AND SCAR TISSUE. THE PATIENT IS UNABLE TO RETURN TO WORK. ASSOCIATED MEDWATCH: 2916714-2020-00646, 2916714-2020-00702, 2916714-2020-00703.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Disorder; Pain

  MAUDE report 10907823 ↗