PERSONA® 42-5026-062-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00889024230361), received between Aug 20, 2020 and Sep 30, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (4 reports).

39 other recalls cover devices cleared under the same FDA submission (K113369, K172524); 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an initial knee surgery. Subsequently, the patient underwent an additional surgery due to pain approximately 3 years post-op. No devices were revised however, a patella implant was placed. It was noted that the patient's BMI was a contributing factor. Attempts have been made and all available information has been provided.

  Patient problems: Pain

  MAUDE report 50944759 ↗
• InjuryAug 6, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that a patient was revised approximately one year and five months post implantation due to femoral loosening. Attempts to obtain additional information have been made; however, no more information is available at this time.

  Patient problems: Aseptic loosening

  MAUDE report 50158757 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS LIGAMENT LAXITY INSTABILITY APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. ALL COMPONENTS WERE REVISED EXCEPT THE PATELLA. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 24444089 ↗
• MalfunctionJan 12, 2026Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE FEMORAL IMPLANT WAS FOUND TO HAVE THE PLASTIC PACKAGING ADHERED TO THE IMPLANT. THE DEBRIS COULD NOT BE REMOVED, APPEARING TO BE MELTED ONTO THE DEVICE. A SECOND IMPLANT WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035577 ↗
• InjuryOct 27, 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: Muscle/Tendon Damage

  MAUDE report 23392639 ↗
• InjuryJul 17, 2025Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOUR AND A HALF YEARS POST IMPLANTATION DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 22531602 ↗
• InjuryJan 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 EXPERIENCED STIFFNESS REQUIRING A MUA APPROXIMATELY 6 MONTHS POST-OP. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 21233073 ↗
• 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 20517398 ↗
• 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 20286860 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO KNEE STIFFNESS AND FLEXION DEFORMITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17684026 ↗
• InjurySep 1, 2023Adverse 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: Adhesion(s); Fall; Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17669736 ↗
• InjuryMay 2, 2023Unstable; Unstable

  IT WAS REPORTED THAT THERE WAS A REVISION FOR INSTABILITY. PATIENT NOTES/RECORDS ARE NOT AVAILABLE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 16853177 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT MANIPULATION UNDER ANESTHESIA AND ASPIRATION APPROXIMATELY FORTY-FIVE DAYS POST-IMPLANTATION DUE TO STIFFNESS. NO INFECTION WAS NOTED WITH THE KNEE ASPIRATION. NO FURTHER INTERVENTIONS HAVE BEEN REPORTED.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 16456117 ↗
• InjurySep 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY HAD A MANIPULATION UNDER ANESTHESIA 4 MONTHS POST PROCEDURE DUE TO ARTHROFIBROSIS, STIFFNESS, AND DECREASED ROM.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 15402415 ↗
• InjuryJul 15, 2022Unstable; Unstable

  IT WAS REPORTED A PATIENT WAS CONVERTED FROM A RIGHT MEDIAL UNCOMPARTMENTALIZED KNEE TO A RIGHT TOTAL KNEE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING ONGOING PAIN, SWELLING, RADIOLUCENCY AT THE MEDIAL TIBIAL PLATEAU, AND POSSIBLE INSTABILITY. ANTI-INFLAMMATORY GEL AND STEROIDS WERE PRESCRIBED TO RELIEVE THE SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema; Weight Changes

  MAUDE report 15026370 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY ABOUT 2 WEEKS POST PROCEDURE A MILD SUPERFICIAL SKIN INFECTION WAS NOTED AND TREATED WITH MEDICAL INTERVENTION THAT RESOLVED APPROXIMATELY ONE MONTH POST INTERVENTION.

  Patient problems: Skin Infection

  MAUDE report 13206335 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEVELOPED PULMONARY EMBOLISM THREE DAYS POST IMPLANTATION. PATIENT WAS TREATED MEDICALLY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Embolism/Embolus

  MAUDE report 13203009 ↗
• InjurySep 22, 2021Unstable; Unstable

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

  Patient problems: Hyperextension; Joint Laxity

  MAUDE report 12512699 ↗
• InjuryOct 6, 2020Loosening 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: No Information

  MAUDE report 10636132 ↗
• InjuryAug 20, 2020Unstable; Unstable

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

  Patient problems: Fall; Pain

  MAUDE report 10432224 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113369, K172524. One submission often covers many models, so check the product and lot details in each record.

• Z-1808-2018 · Aug 7, 2017 · Terminated
  Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.
• Z-1805-2018 · Aug 7, 2017 · Terminated
  Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
• Z-1806-2018 · Aug 7, 2017 · Terminated
  Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
• Z-1807-2018 · Aug 7, 2017 · Terminated
  Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
• Z-1340-2016 · Mar 17, 2016 · Terminated
  Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
• Z-1341-2016 · Mar 17, 2016 · Terminated
  Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18
• Z-1157-2016 · Jan 11, 2016 · Terminated
  Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL
• Z-1360-2015 · Mar 10, 2015 · Terminated
  Brand Name: Persona Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthrop
• Z-0853-2015 · Dec 4, 2014 · Terminated
  Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA p
• Z-1042-2015 · Nov 25, 2014 · Terminated
  Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
• Z-0198-2015 · Oct 9, 2014 · Terminated
  Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, t
• Z-0123-2015 · Oct 7, 2014 · Terminated
  The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the
• Z-2576-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 E
• Z-2577-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12
• Z-2579-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6

…and 24 more.