Persona® 42-5558-031-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024557512), received between May 26, 2022 and Dec 27, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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.

• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, ERYTHEMA, SWELLING, FEMORAL LOOSENING AND PERIPROSTHETIC, MEDIAL FEMORAL CONDYLE FRACTURE APPROXIMATELY FOUR YEARS POST IMPLANTATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 21027312 ↗
• 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 PAIN, OSTEOPENIA AND POTENTIAL TIBIAL LOOSENING APPROXIMATELY TWO (2) YEARS FOLLOWING LEFT KNEE ARTHROPLASTY. A KNEE IMMOBILIZER WAS RECOMMENDED TEMPORARILY FOR TREATMENT. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 14653902 ↗
• 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 PAIN, OSTEOPENIA AND POTENTIAL TIBIAL LOOSENING APPROXIMATELY TWO (2) YEARS FOLLOWING LEFT KNEE ARTHROPLASTY. A KNEE IMMOBILIZER WAS RECOMMENDED TEMPORARILY FOR TREATMENT. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 14653889 ↗
• 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 14517252 ↗
• 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 14517038 ↗

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: