PERSONA® 42-5570-001-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00889024247734), received between Nov 4, 2019 and Aug 10, 2026 — classified as 54 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (13 reports).

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 75 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent an initial left knee surgery. Subsequently, the patient was revised due to femoral and tibial loosening approximately 4 years post-op. All available information has been provided.

  Patient problems: Aseptic loosening

  MAUDE report 50191689 ↗
• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 3 YEARS POST-OP, THE PATIENT IS EXPERIENCING PAIN AND A LIMITED RANGE OF MOTION. THERE ARE NO PLANS TO PURSUE A REVISION SURGERY AT THIS TIME AS X-RAYS SHOW NO COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 25649689 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT HAD A STAGE ONE REVISION DUE TO UNKNOWN REASONS; ALL COMPONENTS WERE REMOVED AND REPLACED WITH SPACERS. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24221953 ↗
• InjuryDec 30, 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

  MAUDE report 23924293 ↗
• InjuryDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Insufficient Information

  MAUDE report 23804273 ↗
• InjuryOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO THE STEM HAVING DISLODGED FROM THE TIBIAL TRAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 23435798 ↗
• MalfunctionSep 6, 2025Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22988111 ↗
• MalfunctionAug 14, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED WHEN TWO STEMS WERE OPENED, THE PLASTIC PACKAGING ON THE STERILE TOP PIECE APPEARED TO HAVE ADHESIVE RESIDUE ADHERED TO THE PLASTIC. THE MALFUNCTION WERE THE SAME WITH BOTH DEVICES' PACKAGING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805765 ↗
• MalfunctionAug 14, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805580 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED A PATIENT UNDERWENT REVISION SURGERY FOR UNKNOWN REASONS ABOUT SIX MONTHS POST PROCEDURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 22308515 ↗
• InjuryMay 29, 2025Malposition of Device; Unintended Movement; Malposition of Device; Unintended Movement

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

  Patient problems: Failure of Implant; Joint Laxity; Synovitis

  MAUDE report 22106038 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING WEAKNESS, IMBALANCE, SWELLING, AND ACHING IN THE KNEE POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 22005377 ↗
• InjuryMar 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL LOOSENING APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21624179 ↗
• InjuryFeb 19, 2025Adverse 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 TOTAL KNEE ARTHROPLASTY. APPROXIMATELY EIGHT (8) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO STIFFNESS OF THE IMPLANTED JOINT. THE FEMORAL COMPONENT, STEM AND ARTICULAR SURFACE WERE EXCHANGED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Muscular Rigidity

  MAUDE report 21413420 ↗
• MalfunctionDec 30, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEBRIS WAS FOUND IN STERILE PACKAGING OF THE DEVICE. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034454 ↗
• InjuryDec 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE IS NOT RELATED TO THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Failure of Implant

  MAUDE report 20912817 ↗
• InjuryOct 29, 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: Loss of Range of Motion

  MAUDE report 20560150 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 10 MONTHS POST IMPLANTATION DUE TO PAIN, SWELLING, AND INSTABILITY. DURING THE REVISION, SCAR TISSUE WAS DEBRIDED AND A MANIPULATION UNDER ANESTHESIA WAS PERFORMED, AND THE COMPONENTS WERE NOTED TO BE WELL FIXED. ALL IMPLANTS WERE REPLACED WITHOUT COMPLICATIONS.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20521482 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO PAIN AND INSTABILITY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20517385 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS THAT WAS IMPACTING ROM FROM ADHESIONS & SCAR TISSUE. PATIENT REMAINS IMPLANTED. PATIENT REPORTS SWOLLEN AND HOT TO THE TOUCH WITH LIMITED RANGE OF MOTION. ONE MONTH LATER, KNEE WAS ASPIRATED FOR RECURRENT PAIN, SWELLING, AND WARMTH PERFORMED. UPON EXAM PERFORMED BY NEW DOCTOR NOTED EFFUSION, MILD PAIN WITH ROM, TENDER TO PALPATION, MODERATE LAXITY WITH VARUS/VALGUS STRESS TEST AND ANTERIOR DRAWER. PATIENT REPORTS LOOSENING AT LAST OFFICE VISIT. PATIENT REPORTED INFECTION AND ARTHROFIBROSIS TO RIGHT KNEE SEVEN MONTHS AFTER LAST UPDATED MEDICAL RECORDS PROVIDED. NO INTERVENTION REPORTED

  Patient problems: Adhesion(s); Alteration in Body Temperature; Failure of Implant; Loss of Range of Motion; Scar Tissue; Swelling/ Edema; Unspecified Infection

  MAUDE report 20301095 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Joint Laxity

  MAUDE report 20285905 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information; Pain

  MAUDE report 19689427 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT BEGAN TO EXPERIENCE PAIN, WARMTH, EFFUSION, AND DECREASED RANGE OF MOTION ABOUT THREE YEARS TWO MONTHS POST IMPLANTATION AND AN ASPIRATION OF THE SYNOVIAL FLUID WAS COMPLETED. THREE DAYS LATER THE PATIENT UNDERWENT AN I&D, WITH POLY EXCHANGE, FOR A PERIPROSTHETIC INFECTION WITHOUT COMPLICATION. AFTER COMPLETING IV AND ORAL ANTIBIOTICS, THE PATIENT BEGAN TO EXPERIENCE PAIN, SWELLING, LIMITED RANGE OF MOTION, AND DIFFICULTY AMBULATING. EIGHT MONTHS AFTER THE I&D, AN ASPIRATION WAS COMPLETED AND THE CULTURE RESULTS INDICATED AN ONGOING INFECTION RELATED TO STAPH EPIDERMITIS. SUBSEQUENTLY, THE PATIENT UNDERWENT THE FIRST STAGE OF A TWO STAGE REVISION WHERE ALL IMPLANTS WERE REMOVED AND A TEMPORARY SPACER WAS IMPLANTED. APPROXIMATELY TWO MONTHS LATER, THE PATIENT UNDERWENT THE SECOND STAGE REVISION WHERE MODERATE OSTEOLYSIS WAS NOTED AROUND THE TIBIAL AND FEMORAL COMPONENTS THAT WAS CONSISTENT WITH THE PREVIOUS INFECTION/EXPLANTATION AND A REVISION KNEE SYSTEM WAS IMPLANTED WITHOUT COMPLICATION.

  Patient problems: Ambulation or Postural Difficulties; Bacterial Infection; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19668381 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE ARTHROPLASTY. APPROXIMATELY 2 MONTHS POST-IMPLANTATION, THE PATIENT SUFFERED A MEDIAL TIBIAL FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. SUBSEQUENTLY, THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 19468546 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. PATIENT REPORTED A POPPING SENSATION WITH FEELING THE JOINT GAVE OUT. THEY NOTED THEIR LAST EPISODE THEY HEARD THE POP AND FELT THE IMPLANT MOVE OUT THEN POP INTO PLACE. THE PATIENT ALSO REPORTED HAVING PAIN AND DIFFICULTY AMBULATING. NO RECORDS WERE PROVIDED. THE PATIENT FOLLOWED UP WITH THEIR SURGEON, WHO ORDERED AN MRI FOR THEIR CONTINUED PAIN, DIFFICULTY AMBULATING, DECREASED RANGE OF MOTION, AND SUBLUXATION. A REVISION WAS PLANNED FOR THE NEAR FUTURE BUT WAS DELAYED DUE TO THE PATIENT'S MEDICAL HISTORY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Subluxation; Swelling/ Edema

  MAUDE report 19461971 ↗