Persona® Trabecular Metal® 42-5028-062-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024230767), received between Jul 30, 2020 and Jun 11, 2025 — classified as 9 injuries, 1 malfunction.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 1 YEAR AND 6 MONTHS POST IMPLANTATION DUE TO FEMORAL LOOSENING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 22183458 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY. ALL COMPONENTS WERE REVISED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 21448669 ↗
• InjuryDec 31, 2024Adverse 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: Insufficient Information; Joint Laxity

  MAUDE report 21048762 ↗
• MalfunctionJul 1, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON OPENING THE IMPLANT BOX, THERE IS OPENING ON THE STERILE PACKAGING. OPENED ANOTHER IMPLANT TO PROCEED WITH SURGERY. NO DELAY OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645881 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 15 DAYS POST IMPLANTATION DUE TO PAIN AND PERIPROSTHETIC FRACTURE FROM FALLING WHILE WALKING TO BATHROOM USING A FOUR-WHEEL WALKER AND NURSING ASSISTANCE. ALL COMPONENTS EXCHANGED WITH NEXGEN ROTATING HINGE COMPONENTS WITHOUT COMPLICATIONS.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 19111139 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO ARTHROFIBROSIS WHICH CAUSED LIMITED RANGE OF MOTION AND STIFFNESS. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION AND ALL IMPLANTS REMAIN IN PLACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 16555184 ↗
• InjuryJan 10, 2022Unstable; Unstable

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE YEAR POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO INSTABILITY. ALL COMPONENTS WERE EXCHANGED WITHOUT INCIDENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 13203553 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS POST-OPERATIVE PAIN AND STIFFNESS APPROXIMATELY FOUR (4) MONTHS POST-OPERATIVELY. INITIAL OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS. AT THE PATIENT'S 3-MONTH POST-OPERATIVE VISIT, THE PATIENT WAS STRUGGLING WITH ANTERIOR KNEE DISCOMFORT, CLICKING SOUNDS IN THE KNEE AND LIMITED RANGE OF MOTION. MANIPULATION OPERATIVE NOTES NOTED RELEASE OF ADHESIONS WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 12556291 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A RIGHT UNILATERAL TKA, AND THE PATIENT EXPERIENCED LYSIS OF ADHESIONS, LIMITED ROM, AND PAIN AND UNDERWENT A MUA APPROXIMATELY SIX MONTHS LATER.

  Patient problems: Limited Mobility Of The Implanted Joint; Muscular Rigidity; Pain

  MAUDE report 10344441 ↗
• InjuryJul 30, 2020Adverse 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: Adhesion(s); Limited Mobility Of The Implanted Joint; Muscular Rigidity; Pain; Scar Tissue

  MAUDE report 10344417 ↗