Persona® 42-5600-075-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00887868249594), received between Feb 4, 2021 and Jun 18, 2026 — classified as 43 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER CEMENTING, THE STEM MOVED DURING TIBIAL PLATE IMPACTION AND HAD DETACHED FROM THE TIBIAL PLATE. IMAGING WAS PERFORMED TO CONFIRM THAT THE DEVICE HAD DISLODGED. THERE WAS A 30 MINUTE SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. A NEW STEM WAS IMPLANTED SUCCESSFULLY, ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546205 ↗
• InjuryNov 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23575536 ↗
• InjuryNov 17, 2025Malposition of Device; Malposition of Device

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

  Patient problems: Ambulation or Postural Difficulties; Crepitus; Numbness; Pain; Swelling/ Edema

  MAUDE report 23567858 ↗
• InjuryOct 27, 2025Malposition of Device; Malposition of Device

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

  Patient problems: Ambulation or Postural Difficulties; Crepitus; Numbness; Pain; Swelling/ Edema

  MAUDE report 23393083 ↗
• MalfunctionAug 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790428 ↗
• InjuryAug 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A FIRST STAGE REVISION OF COMPETITOR PRODUCTS, AND WAS IMPLANTED WITH ZIMMER BIOMET DEVICES. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 22709210 ↗
• InjuryAug 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A FIRST STAGE REVISION OF COMPETITOR PRODUCTS, AND WAS IMPLANTED WITH ZIMMER BIOMET DEVICES. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 22709191 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT REPORTED MODERATE PAIN TO THE KNEE WITH EXTREME PAIN STANDING UPRIGHT AND BENDING TO THE FLOOR DURING THE TWO YEAR FOLLOW UP. THE PATIENT HAS IMPROVED AS THE STUDY CONTINUED, ALL RADIOGRAPHIC IMAGING DISPLAYS NO SIGNIFICANT FINDINGS, AND ALL PRODUCTS REMAIN IMPLANTED.

  Patient problems: Pain

  MAUDE report 22077608 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT REPORTED MODERATE PAIN TO THE KNEE WITH EXTREME PAIN STANDING UPRIGHT AND BENDING TO THE FLOOR DURING THE TWO YEARS FOLLOW UP. THE PATIENT HAS IMPROVED AS THE STUDY CONTINUED, ALL RADIOGRAPHIC IMAGING DISPLAYS NO SIGNIFICANT FINDINGS, AND ALL PRODUCTS REMAIN IMPLANTED.

  Patient problems: Pain

  MAUDE report 22077597 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN APPROXIMATELY TWO YEARS POST IMPLANTATION. ALL RADIOGRAPHIC IMAGING DISPLAYS NO SIGNIFICANT FINDINGS AND ALL PRODUCTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 22072833 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN APPROXIMATELY TWO YEARS POST IMPLANTATION. ALL RADIOGRAPHIC IMAGING DISPLAYS NO SIGNIFICANT FINDINGS AND ALL PRODUCTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 22072801 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED AS THIS EVENT IS NOT REPORTABLE.

  Patient problems: Fever; Joint effusion; Pain; Unspecified Infection

  MAUDE report 21909467 ↗
• 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 21027370 ↗
• 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 21027288 ↗
• InjuryJul 10, 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: Pain; Radiolucent Lines

  MAUDE report 19709148 ↗
• InjuryJul 10, 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: Pain; Radiolucent Lines

  MAUDE report 19709113 ↗
• InjuryJul 8, 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: Fall; Pain

  MAUDE report 19697418 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT BEGAN TO EXPERIENCE AN INCREASE IN PAIN APPROXIMATELY 8 MONTHS POST PROCEDURE. THE PATIENT WAS PRESCRIBED A MEDROL PACK AND AN ADDITIONAL COURSE OF PHYSICAL THERAPY. THE PAIN IMPROVED BUT RETURNED AROUND 2 WEEKS LATER WHERE IT WAS PRESENTED OVER THE LCL AND A GENICULAR BLOCK WAS RECOMMENDED. ALL RADIOGRAPHIC IMAGING DISPLAYS IMPLANTS IN GOOD POSITION WITHOUT GROSS FAILURE OR LOOSENING AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Pain

  MAUDE report 19567534 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS SEEN IN THE OFFICE ABOUT THREE YEARS POST IMPLANTATION AFTER SUBSEQUENT FALLS AND NOW EXPERIENCING PAIN AND A SIGNIFICANT EFFUSION. THE PATIENT HAS A FIVE DEGREE EXTENSOR LAG SECONDARY TO THE PAIN AND SWELLING AND AT THE OFFICE APPOINTMENT, AN ASPIRATION WAS PERFORMED. LIMITED BLOODY FLUID WAS COLLECTED AS IT WAS THOUGHT TO BE COAGULATED. ALL RADIOGRAPHIC IMAGING DISPLAYS IMPLANTS IN GOOD POSITION WITHOUT SIGNS OF GROSS FAILURE OR LOOSENING AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Fall; Hematoma; Joint effusion; Loss of Range of Motion; Pain

  MAUDE report 19567037 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS SEEN IN THE OFFICE ABOUT THREE YEARS POST IMPLANTATION AFTER SUBSEQUENT FALLS AND NOW EXPERIENCING PAIN AND A SIGNIFICANT EFFUSION. THE PATIENT HAS A FIVE DEGREE EXTENSOR LAG SECONDARY TO THE PAIN AND SWELLING AND AT THE OFFICE APPOINTMENT, AN ASPIRATION WAS PERFORMED. LIMITED BLOODY FLUID WAS COLLECTED AS IT WAS THOUGHT TO BE COAGULATED. ALL RADIOGRAPHIC IMAGING DISPLAYS IMPLANTS IN GOOD POSITION WITHOUT SIGNS OF GROSS FAILURE OR LOOSENING AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Fall; Hematoma; Joint effusion; Loss of Range of Motion; Pain

  MAUDE report 19567018 ↗
• InjuryJun 14, 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); Extraskeletal ossification; Pain; Radiolucent Lines

  MAUDE report 19536568 ↗
• InjuryJun 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE IMPLANTS AND REPORTED PAIN. THE IMPLANTS WERE FOUND TO BE LOOSE BUT WELL-ADHERED TO THE CEMENT MANTLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 19481413 ↗
• InjuryJun 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE IMPLANTS AND REPORTED PAIN. THE IMPLANTS WERE FOUND TO BE LOOSE BUT WELL-ADHERED TO THE CEMENT MANTLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 19468909 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A REVISION 7 YEARS LATER DUE TO ASEPTIC LOOSENING. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN OVER THE PES BURSA AND WAS INITIAL PRESCRIBED NSAIDS AND PHYSICAL THERAPY FOR PES ANSERINUS BURSITIS. THE PATIENT RECEIVED A CORTISONE INJECTION SIXTEEN MONTHS POST REVISION. ALL IMPLANTS REMAIN IN PLACE AND AT THE TWO-YEAR FOLLOW-UP, REPORTS NO PAIN.

  Patient problems: Bursitis; Pain

  MAUDE report 19139797 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A REVISION 7 YEARS LATER DUE TO ASEPTIC LOOSENING. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN OVER THE PES BURSA AND WAS INITIAL PRESCRIBED NSAIDS AND PHYSICAL THERAPY FOR PES ANSERINUS BURSITIS. THE PATIENT RECEIVED A CORTISONE INJECTION SIXTEEN MONTHS POST REVISION. ALL IMPLANTS REMAIN IN PLACE AND AT THE TWO-YEAR FOLLOW-UP, REPORTS NO PAIN.

  Patient problems: Bursitis; Pain

  MAUDE report 19139784 ↗

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: