Persona® 42-5420-064-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024562776), received between Nov 9, 2021 and Jun 10, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING POTENTIAL TIBIAL LOOSENING APPROXIMATELY TWO (2) YEARS FOLLOWING LEFT KNEE ARTHROPLASTY. NO ADVERSE EFFECTS OR MEDICAL INTERVENTION HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain

  MAUDE report 14653397 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AN INJECTION FOR PES BURSITIS APPROXIMATELY SEVENTEEN (17) MONTHS FOLLOWING A LEFT KNEE ARTHROPLASTY TO ADDRESS CONTINUOUS POST-OPERATIVE PAIN AND SWELLING. THE PATIENT'S PAIN RESOLVED AFTER THE INJECTION WAS ADMINISTERED, HOWEVER, THE PATIENT CONTINUED TO HAVE WORSENING MODERATE EFFUSION. INITIAL OPERATIVE NOTES NOTED THAT THE PARTIAL KNEE ARTHROPLASTY TRACKED WITHOUT COMPLICATION AND THE PATIENT'S RANGE OF MOTION WAS ZERO (0) TO ONE-HUNDRED FORTY (140) DEGREES AND STABLE. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14517025 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX MONTHS POST THE REVISION KNEE ARTHROPLASTY SURGERY THE PATIENT HAD PAIN, BURSITIS, TENDONITIS AND IT BAND SYNDROME. THE PATIENT WAS INJECTED WITH MEDICATION AND INSTRUCTED TO USE ANTI-INFLAMMATORY CREAM AND A COMPRESSION SLEEVE. THE PRODUCTS REMAIN IMPLANTED AND THERE ARE NO PLANS FOR A SECOND REVISION SURGERY AT THIS TIME.

  Patient problems: Inflammation; Pain

  MAUDE report 12782588 ↗

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: