Persona® 42-5601-135-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868249815), received between Jun 2, 2022 and Jul 10, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY THAT UNDERWENT A TOTAL KNEE PROCEDURE. SUBSEQUENTLY, TWO (2) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION, THE PATIENT REPORTED SEVERE PAIN AND A CONCERN OF WEAKNESS. ONGOING TENDINITIS/BURSITIS AND MILD EFFUSION WERE ALSO NOTED ON EXAM. ON THE NEXT FOLLOW-UP SIX (6) MONTHS LATER, RADIOGRAPHIC IMAGING DISPLAYED POSSIBLE LOOSENING AND BONE LOSS. THE PATIENT WISHES TO MANAGE THESE SYMPTOMS CONSERVATIVELY WITH HOME CARE AND OBSERVATION AT THIS TIME. ALL COMPONENTS REMAIN IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Bursitis; Joint effusion; Muscle Weakness/Atrophy; Osteopenia/ Osteoporosis; Pain; Tendinopathy

  MAUDE report 22472150 ↗
• InjuryJul 1, 2022Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY PROCEDURE. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN, CREPITUS AND INSTABILITY. APPROXIMATELY TWO MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY. DURING THE SURGERY, A TIBIAL CORTEX FRACTURE WAS NOTED WHICH RESULTED IN SUBSIDENCE AND MINIMAL FIXATION OF THE TIBIAL COMPONENTS. THE TIBIAL BASEPLATE WAS ALSO NOTED TO HAVE DETACHED FROM THE TIBIAL STEM COMPONENT. AFFECTED COMPONENTS WERE REVISED WITHOUT REPORTED COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Failure of Implant; Joint Laxity; Osteopenia/ Osteoporosis; Pain

  MAUDE report 14886462 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND TENDERNESS OF THE PES ANSERINUS AND ILIOTIBIAL TRACT REQUIRING A CORTISONE INJECTION TWO YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Bursitis; Loss of Range of Motion; Pain

  MAUDE report 14582565 ↗

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: