Persona® 42-5601-135-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887868249822), received between Feb 22, 2022 and Jul 10, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY THAT UNDERWENT A TOTAL KNEE PROCEDURE. SUBSEQUENTLY, TWO (2) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION, THE PATIENT REPORTED SEVERE PAIN AND A CONCERN OF WEAKNESS. ONGOING TENDINITIS/BURSITIS AND MILD EFFUSION WERE ALSO NOTED ON EXAM. ON THE NEXT FOLLOW-UP SIX (6) MONTHS LATER, RADIOGRAPHIC IMAGING DISPLAYED POSSIBLE LOOSENING AND BONE LOSS. THE PATIENT WISHES TO MANAGE THESE SYMPTOMS CONSERVATIVELY WITH HOME CARE AND OBSERVATION AT THIS TIME. ALL COMPONENTS REMAIN IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Bursitis; Joint effusion; Muscle Weakness/Atrophy; Osteopenia/ Osteoporosis; Pain; Tendinopathy

  MAUDE report 22472055 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 19719792 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT RIGHT KNEE A TWO STAGE REVISION FOR INFECTION. SUBSEQUENTLY, APPROXIMATELY 7 MONTHS LATER THE PATIENT BEGAN TO HAVE INTERMITTENT PAIN AND SWELLING AND 2 YEARS FIVE MONTHS REPORTED AN INCREASE IN PAIN AND WAS PRESCRIBED PHYSICAL THERAPY. ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19139729 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY NINE MONTHS POST KNEE ARTHROPLASTY REVISION, THE PATIENT REPORTED MILD ANTERIOR KNEE PAIN AND WAS PRESCRIBED PHYSICAL THERAPY AND GIVEN STEROID INJECTION FOR IT BAND AND PER ANSERINE BURSITIS. THE PATIENT¿S PAIN CONTINUED THROUGHOUT THE COURSE OF THE STUDY AND TWO YEARS, THREE MONTHS LATER, REPORTED SEVERE PAIN AND STIFFNESS TO THE RIGHT KNEE. NO SIGNIFICANT FINDINGS WERE FOUND ON RADIOGRAPHIC IMAGING, AND THE ONGOING PAIN IS ATTRIBUTED TO THE PATIENT'S SPINAL STENOSIS.

  Patient problems: Bursitis; Pain

  MAUDE report 16732418 ↗
• InjuryJun 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERED FOR A REVISION ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678681 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS EXPERIENCING MILD SWELLING, STIFFNESS AND PES ANSERINE TENDERNESS APPROXIMATELY 3 MONTHS POST IMPLANTATION. MILD BLOODY DRAINAGE AND PERIINCISIONAL DRAINAGE WAS ALSO NOTED. PATIENT WAS TREATED WITH VOLTAREN TOPICAL GEL AND PHYSICAL THERAPY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 13576755 ↗

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: