Persona® 42-5558-033-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024557147), received between Jul 1, 2022 and Oct 9, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Unstable” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS LATERAL COLLATERAL LIGAMENT LAXITY INSTABILITY, HAMSTRING TENDON RUPTURE, PAIN AND AMBULATION LIMITATIONS APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. DURING THE REVISION PROCEDURE, THE PATIENT'S TISSUE WAS IDENTIFIED TO BE DAMAGED WITH INFLAMED SYNOVIUM AND A SYNOVECTOMY WITH DEBRIDEMENT WAS ADDITIONALLY PERFORMED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED THE PATIENT WAS REVISED DUE TO INSTABILITY WITH INCREASED LAXITY ON LATERAL THROUGHOUT THE ARC OF MOTION. DURING THE PROCEDURE, TISSUE DAMAGE WITH INFLAMED SYNOVIUM WAS IDENTIFIED. THE SURGEON PERFORMED EXTENSIVE EXCISIONAL DEBRIDEMENT THROUGH FIBRINOUS SUPERFICIAL TISSUE DOWN TO DEEP CAPSULAR TISSUE. THE TIBIAL AND FEMORAL COMPONENTS WERE IDENTIFIED TO BE ALIGNED AND STABLE, BUT THE ARTICULAR SURFACE WAS REVISED AND REPLACED. NO OTHER INTRAOPERATIVE COMPLICATIONS WERE IDENTIFIED.

  Patient problems: Ambulation or Postural Difficulties; Muscle/Tendon Damage; Pain; Synovitis

  MAUDE report 17894296 ↗
• InjuryJul 1, 2022Unstable; Unstable

  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 14886728 ↗

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: