Persona® Trabecular Metal® 42-5028-074-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024230859), received between Sep 27, 2021 and May 14, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY AND ONE DAY POST-OP EXPERIENCED A SIGNIFICANT AMOUNT OF DRAINAGE. TWO ADDITIONAL SUTURES WERE PLACED TO THE DISTAL PORTION OF THE INCISION. EIGHT DAYS LATER, THE PATIENT WAS SEEN IN THE OFFICE FOR A FOLLOW-UP APPOINTMENT AND THE DOCTOR NOTES HE COULD SEE WHERE HE HAD SOME BLOODY DRAINAGE AT THE DISTAL PORTION OF THE INCISION. DERMABOND WAS PLACED ON THE DISTAL INCISION AND THE PATIENT WAS PLACED IN A KNEE IMMOBILIZER FOR THE WEEKEND AND PRESCRIBED PROPHYLACTIC ANTIBIOTICS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT FURTHER WOUND COMPLICATIONS.

  Patient problems: Fluid Discharge

  MAUDE report 19315326 ↗
• InjurySep 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. SUBSEQUENTLY, THE TIBIAL, FEMORAL, AND PATELLAR COMPONENTS WERE REVISED APPROXIMATELY 7 MONTHS LATER DUE TO POSSIBLE ASEPTIC LOOSENING. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15370443 ↗
• InjurySep 27, 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: Pain; Swelling/ Edema

  MAUDE report 12533085 ↗