PERSONA® Vivacit-E® 42-5221-009-10 (UDI 00889024468498)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00889024468498), received between Mar 23, 2020 and Sep 25, 2026 — classified as 17 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device Contaminated During Manufacture or Shipping

  It was reported that a hair was observed inside the sterile package. There was no patient involvement. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896920 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Arthrofibrosis

  MAUDE report 50858448 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an initial right surgery. Subsequently, 2.5 years post-implantation a revision was performed due to instability. The articular surface was exchanged. Attempts have been made and no further information has been provided.

  Patient problems: Joint Laxity

  MAUDE report 50853366 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a right knee arthroplasty revision to address tibial fibrous ingrowth approximately two (2) years post-operatively.Attempts have been made and no further information has been provided.

  Patient problems: Arthrofibrosis

  MAUDE report 50192562 ↗
• InjuryAug 6, 2026Fracture; Peeled/Delaminated; Pitted

  It was reported that a patient has had ongoing stiffness, pain, and decreased range of motion. The patient is now twelve months post total knee replacement. An arthroscopic procedure was done, and the surgeon noted synovitis, poly pitting, edge cracking and delamination. The articular surface has not been removed. There is no additional information available.

  Patient problems: Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 50157154 ↗
• MalfunctionJun 12, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WAS UNABLE TO FIT INTO THE TIBIAL TRAY. A SECOND IMPLANT WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491702 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Loss of Range of Motion

  MAUDE report 24613411 ↗
• InjuryDec 18, 2025Adverse 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; Swelling/ Edema

  MAUDE report 23844009 ↗
• InjuryDec 16, 2025Adverse 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: Joint effusion; Pain; Synovitis

  MAUDE report 23817032 ↗
• MalfunctionDec 14, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF THE IMPLANT WAS FOUND TO BE SEVERELY DAMAGED UPON RECEIPT. DUE TO POTENTIAL BREACH OF STERILITY, THE CUSTOMER OPTED TO NOT USE THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799586 ↗
• MalfunctionNov 11, 2025Product Quality Problem; Defective Device; Product Quality Problem; Defective Device

  IT WAS REPORTED THAT THE POLY WAS DAMAGED, AND ASSUMED MANUFACTURING DEFICIENCY BY THE REPORTER. SURGERY WAS COMPLETED WITH A SECOND DEVICE. THERE WAS NO IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523296 ↗
• MalfunctionOct 15, 2025Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280451 ↗
• MalfunctionSep 8, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AN ARTICULAR SURFACE WOULD NOT ASSEMBLE WITH A TIBIAL TRAY. THE SURGEON ATTEMPTED TO PLACE THE MC BEARING ON THE BASE PLATE AND IT DIDN'T FIT WELL; ANOTHER ARTICULAR SURFACE WAS USED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991456 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT KNEE SWELLING AND LIMITED RANGE OF MOTION APPROXIMATELY ONE (1) MONTH FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS TREATED WITH A STEROID AND COMPRESSION SLEEVE TO ADDRESS INFLAMMATION. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Loss of Range of Motion; Swelling/ Edema

  MAUDE report 22806297 ↗
• InjuryJul 30, 2025Adverse 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 22668645 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT UNDERWENT THE FIRST STAGE OF A TWO STAGE REVISION DUE TO A MSSA INFECTION ON AN UNKNOWN DATE. DURING STAGE I, THE PATIENT WAS IMPLANTED WITH AN UNKNOWN CEMENT SPACER WHICH WAS REVISED DURING STAGE 2 TO A ROTATING HINGE CONSTRUCT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 22588575 ↗
• MalfunctionJun 2, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE ARTICULAR SURFACE COULD NOT BE SEATED ON THE TIBIAL TRAY. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123869 ↗
• MalfunctionMay 22, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE SURGEON STRUGGLED TO GET THE BEARING SEATED ONTO THE TIBIAL TRAY. AFTER MANY ATTEMPTS HE TRIED A DIFFERENT BEARING AND IT FITTED WITHOUT A PROBLEM. NO PATIENT HARM OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073176 ↗
• InjuryDec 30, 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 RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 16 DAYS POST-OP, THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC FOR MILD REDNESS TO PROXIMAL INCISION AS A PROPHYLAXIS TREATMENT AND IT RESOLVED WITH NO FURTHER ALLEGATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Erythema; Post Operative Wound Infection

  MAUDE report 21036277 ↗
• InjuryNov 18, 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: Joint Laxity

  MAUDE report 20716180 ↗
• MalfunctionJun 11, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A PROCEDURE, A HAIR WAS FOUND IN THE STERILE PACKAGING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510019 ↗
• MalfunctionApr 3, 2024Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT ON AN MC POLY, THERE WAS A PIECE OF PLASTIC THAT SEEMED OUT OF PLACE ON THE UNDERSIDE OF THE POLY. IT CAUSED THE POLY TO NOT LOCK INTO THE TIBIA. THE ISSUE WAS DISCOVERED AFTER IMPLANTING THE DEVICE INITIALLY. THE SURGEON HAD TO USE A DIFFERENT POLY WHICH TIGHTENED UP THE KNEE MORE THAN THEY WANTED TO INITIALLY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19030732 ↗
• MalfunctionDec 20, 2023Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18368138 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA STUDY A PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, SWELLING, DECREASED RANGE OF MOTION, DIFFICULTY WITH MOBILITY, AND A BAKER¿S CYST ALSO FORMED. SUBSEQUENTLY, APPROXIMATELY FIVE MONTHS LATER, THE PATIENT UNDERWENT AN ARTHROSCOPIC PROCEDURE FOR LYSIS OF SCAR TISSUE AND ADHESIONS AS WELL AS DRAINAGE OF THE CYST. AT THE ONE YEAR CHECK-UP ALL THE KNEE COMPONENTS REMAIN IN PLACE AND THE PATIENT IS REPORTEDLY NOW DOING WELL WITH NO FURTHER COMPLICATIONS KNOWN.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Cyst(s); Joint effusion; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17383685 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 4 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO PAIN, STIFFNESS, AND LIMITED FLEXION. AFTER THE SURGERY, THE PATIENT CONTINUED TO IMPROVE AND HAS GAINED FULL RANGE OF MOTION. ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15543645 ↗