Persona® 42-5720-058-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024575851), received between Jan 21, 2022 and Oct 23, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (1 report).

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.

• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A POST-OPERATIVE DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. SUBSEQUENTLY, AT THE TWO-YEAR FOLLOW-UP, THE PATIENT REPORTED INCREASING KNEE PAIN WITH TIGHTNESS AND SPASMS. THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY AND INSTRUCTED TO MONITOR WATER AND ELECTROLYTE INTAKE. ALL IMPLANTS REMAIN IN PLACE AND IF THE SYMPTOMS PERSIST, WILL CONSIDER A FURTHER EVALUATION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED

  Patient problems: Cramp(s) /Muscle Spasm(s); Joint effusion; Pain; Swelling/ Edema

  MAUDE report 20517411 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TKA. APPROXIMATELY 5.5 WEEKS LATER, THE PATIENT PRESENTED AT THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AND RIGHT FLANK PAIN. BILATERAL PULMONARY EMBOLISMS WERE DIAGNOSED ON CT AND LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS CONFIRMED BY ULTRASOUND. THE PATIENT WAS PLACED ON ADDITIONAL ANTICOAGULANTS AND DISCHARGED THE NEXT DAY. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 15923876 ↗
• MalfunctionJan 21, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THE LABEL DOESN'T MATCH THE REFERENCE NUMBER. REF NUMBER IS FOR A TIVANIUM FEMUR. DESCRIPTION IS FOR A CEMENTED FEMUR. THERE IS NO PATIENT INVOLVEMENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314795 ↗