Persona® Trabecular Metal® 42-5028-066-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024230804), received between Jan 12, 2021 and Mar 16, 2026 — classified as 6 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion

  MAUDE report 24613404 ↗
• InjuryOct 14, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE PROCEDURE. APPROXIMATELY 2 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 20445535 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY WAS PERFORMED. SUBSEQUENTLY, APPROXIMATELY 2 MONTHS POST PROCEDURE, THE PATIENT HAD A PARTIAL WOUND DEHISCENCE, RESULTING IN EXTENSIVE WOUND CARE AND DELAYING FUNCTIONAL RECOVERY. THE PATIENT WAS PLACED ON RANGE OF MOTION RESTRICTIONS TO ALLOW WOUND HEALING. AFTER FULL HEALING OF THE WOUND OCCURRED, PHYSICAL THERAPY AND MANIPULATION OF THE JOINT RESUMED TO RESTORE FULL FUNCTION. THE PATIENT REMAINS SATISFIED WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Loss of Range of Motion; Pain; Wound Dehiscence

  MAUDE report 17169710 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXPERIENCED A POP IN THE POSTERIOR KNEE, PAIN AND AN EFFUSION FROM HEMARTHROSIS SEVENTEEN DAYS POST IMPLANTATION. PATIENT UNDERWENT AN IN OFFICE ASPIRATION, FOLLOWED BY A SECOND ASPIRATION, DUE TO A RECURRENT EFFUSION. ASPIRATIONS WERE COMPLETED WITHOUT COMPLICATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint effusion; Pain

  MAUDE report 17073501 ↗
• InjuryApr 6, 2023Unstable; Noise, Audible; Unstable; Noise, Audible

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVEN MONTHS POST IMPLANTATION DUE TO CLICKING, LOOSENESS, LAXITY, EFFUSION, AND INSTABILITY. POLY WAS EXPLANTED, ALL OTHER COMPONENTS WERE NOT LOSE OR SUBSIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint Laxity; Swelling/ Edema

  MAUDE report 16692539 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Cellulitis; Loss of Range of Motion; Pain; Swelling; Swelling/ Edema; Unspecified Infection

  MAUDE report 11154523 ↗