Persona® 42-5558-032-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024557529), received between Apr 1, 2022 and Apr 1, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST-IMPLANTATION, THE PATIENT REPORTS PERSISTENT PAIN. RADIOLOGY RESULTS REVEAL INCREASED RADIOLUCENCY CONCERNING FOR LOOSENING OF THE TIBIA AND A STABLE PERIPROSTHETIC FRACTURE AT THE LATERAL FEMORAL CONDYLE. DUE TO THE BONE LOSS FROM TWO PRIOR REVISIONS, THE PATIENT DOES NOT WANT TO PURSUE ANOTHER REVISION AND WILL BE TREATED CONSERVATIVELY AT THIS TIME.

  Patient problems: Osteopenia/ Osteoporosis; Pain

  MAUDE report 13977896 ↗

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: