PERSONA™ 42-5099-025-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024232532), received between Dec 17, 2019 and Apr 30, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PINK FOREIGN OBJECT HAD BEEN FOUND INSIDE THE PLASTIC BAG THAT CONTAINED THE STERILE SCREWS. IT WAS DISCOVERED IMMEDIATELY AFTER OPENING THE BAG. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935095 ↗
• InjuryMar 18, 2024Unstable; Malposition of Device; Unstable; Malposition of Device

  IT WAS REPORTED A PATIENT REPORTS PAIN, INTERMITTENT SWELLING, AND DEFORMITY SINCE SURGERY AND THEN BEGAN EXPERIENCING INSTABILITY, AND A FLEXION CONTRACTURE. RADIOGRAPHIC IMAGING DISPLAYED LUCENCY OF THE FEMORAL COMPONENT AND PATELLAR BUTTON AND 12 DEGREES VARUS ALIGNMENT OF THE TIBIAL COMPONENT. APPROXIMATELY ONE YEAR POST IMPLANTATION THE PATIENT UNDERWENT A REVISION FOR INSTABILITY, ARTHROFIBROSIS, AND MALALIGNMENT. ALL COMPONENTS, EXCEPT THE PATELLA, WERE REVISED WITHOUT COMPLICATION. DURING THE SURGERY, CULTURES WERE TAKEN AND LATER, ONE OF THE CULTURES FROM THE FEMORAL MEMBRANE, GREW EVIDENCE OF PROPIONIBACTERIUM ACNES. THE PATIENT WAS PLACED ON A THREE-MONTH COURSE OF ORAL DOXYCYCLINE. THE PATIENT HAS CONTINUED THROUGH THE STUDY WITHOUT ONGOING INFECTION RELATED COMPLICATIONS.

  Patient problems: Adhesion(s); Bacterial Infection; Deformity/ Disfigurement; Joint Contracture; Joint effusion; Pain; Scar Tissue

  MAUDE report 18924835 ↗
• InjuryJun 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING REMOVAL, THE HEAD OF THE HEXAGONAL FEMALE WAS DAMAGED AND COULD NOT BE REMOVED. IT REMAINED IN THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17154125 ↗
• MalfunctionDec 17, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE PACKAGE, THERE WAS FOREIGN MATTER INSIDE THE STERILE PACKAGE. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9480405 ↗