Persona® 42-5601-135-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887868249808), received between Mar 29, 2022 and Sep 16, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 other recall cover devices cleared under the same FDA submission (K181947, K191625); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

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

  It was reported that a patient hyperextended the right knee and reported swelling and pain about three months post implantation. Approximately two and half year's post implantation the patient complained of moderate pain and refused x-rays. Three years and three months after the patient refused x-rays, a right open lysis of adhesions with possible lateral release and polyethylene exchange due to arthrofibrosis was ordered. No further information provided.

  Patient problems: Arthrofibrosis; Hyperextension; Pain; Swelling/ Edema

  MAUDE report 50792709 ↗
• InjurySep 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE A LOSS OF RANGE OF MOTION AND AN INFECTION WAS SUSPECTED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY WHERE LOOSENING WAS FOUND HOWEVER THE INFECTION RESULTS WERE INCONCLUSIVE. ALL COMPONENTS WERE REVISED WITHOUT COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Loss of Range of Motion; Unspecified Infection

  MAUDE report 20226705 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO (2) FALLS APPROXIMATELY SEVENTEEN (17) MONTHS AND FORTY (40) MONTHS FOLLOWING A RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS PRESCRIBED ANTI-INFLAMMATORIES AND REHABILITATION WAS RECOMMENDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Fall; Pain

  MAUDE report 19721716 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ASPIRATION, ARTHROCENTESIS AND TRIAMCINOLONE ACETONIDE INJECTIONS TO ADDRESS PAIN, SYNOVITIS, LOSS OF RANGE OF MOTION, JOINT EFFUSION AND SWELLING APPROXIMATELY SIX MONTHS FOLLOWING LEFT KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18901940 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED COUGH, SHORTNESS OF BREATH, RIB PAIN, BACK PAIN, NAUSEA/VOMITING, AND DIARRHEA WHICH PROGRESSED TO DIFFICULTY BREATHING AND THE PATIENT WAS HOSPITALIZED APPROXIMATELY THREE WEEKS POST IMPLANTATION WITH PULMONARY EMBOLISM AND PNEUMONIA. THESE ISSUES WERE RESOLVED APPROXIMATELY SEVEN MONTHS LATER WITH MEDICAL TREATMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Embolism/Embolus; Pneumonia

  MAUDE report 13942618 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181947, K191625. One submission often covers many models, so check the product and lot details in each record.

• Z-2578-2026 · May 11, 2026 · Open, Classified
  Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: