PERSONA® 42-5026-064-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024230385), received between Mar 16, 2020 and Jun 23, 2025 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 1 YEAR POST-OP, THE PATIENT DEVELOPED PAIN AND EFFUSION. SIX ASPIRATIONS HAVE BEEN PERFORMED WITH THE LATEST RESULTING IN 600 WBC AND THE PATIENT WAS DIAGNOSED WITH SYNOVITIS. X-RAY SHOWED FEMORAL COMPONENT LOOSENING ALONG WITH COMPLAINTS OF AMBULATION DIFFICULTIES AND JOINT LAXITY. REVISION WAS RECOMMENDED BY SURGEON. NO FURTHER INFORMATION PROVIDED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Joint Laxity; Joint effusion; Loss of Range of Motion; Pain; Synovitis

  MAUDE report 22307403 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION AS THEY WERE UNHAPPY AND HAD A STIFF KNEE. IT WAS ALSO NOTED THE PATIENT SUSTAINED A FALL, BUT IT IS UNKNOWN IF THE STIFFNESS CAUSED THE FALL, OR WAS A RESULTING SYMPTOM AFTER THE FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20143728 ↗
• 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

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWENTY MONTHS POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19689392 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TEN MONTHS POST IMPLANTATION DUE TO PAIN, SWELLING, PERIPROSTHETIC FRACTURE, IMPLANT LOOSENING, AND INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Joint Contracture; Osteolysis; Osteopenia/ Osteoporosis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19166599 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN IN KNEE AND UNABLE TO STAND OR WALK FOR JUST A FEW MINUTES THREE YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17469684 ↗
• MalfunctionMar 19, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A HAIR INSIDE THE PACKAGING WITH THE IMPLANT. ANOTHER IMPLANT WAS OPENED AND USED TO COMPLETE THE SURGERY. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825231 ↗
• InjuryFeb 24, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A STUDY PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY. APPROXIMATELY THREE MONTHS POST-IMPLANTATION THE PATIENT UNDERWENT A CLOSED BRISEMENT PROCEDURE DUE TO A LOSS IN RANGE OF MOTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 13593883 ↗
• InjuryNov 18, 2021Adverse 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: Cramp(s) /Muscle Spasm(s); Hypersensitivity/Allergic reaction; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12837852 ↗
• MalfunctionNov 2, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

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

  Patient problems: Insufficient Information

  MAUDE report 12736781 ↗
• InjuryJul 20, 2021Loosening 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: Failure of Implant; Unspecified Infection

  MAUDE report 12197557 ↗
• InjuryOct 1, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 3 MONTHS AGO, THE PATIENT FELT PAIN, AFTER AN INITIAL TKA THREE YEARS PRIOR, AND WENT TO SEE A DOCTOR. A REVISION WAS PERFORMED LAST MONTH TO REPLACE WITH RHK IMPLANTS, DUE TO FEMORAL COMPONENT LOOSENING AND SUSPECTED INFECTION. USING AN DEFENSIN DETECTION KIT DURING SURGERY, THE REACTION OF PATHOGENS AROUND THE ARTIFICIAL JOINT WAS EXAMINED AND NEGATIVE, AND THE INFECTION WAS FOUND TO BE NEGATIVE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 10613092 ↗
• InjuryMar 16, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL RIGHT KNEE ARTHROPLASTY AND SUBSEQUENTLY, HE EXPERIENCED RIGHT KNEE PATELLAR CLUNK AND RECEIVED AN INTRAARTICULAR CORTICOSTEROID INJECTION APPROXIMATELY ONE YEAR LATER.

  Patient problems: Pain; Tissue Damage

  MAUDE report 9834867 ↗

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-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-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-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-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-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-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-2580-2014 · Aug 7, 2014 · Terminated
  PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3
• 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-2578-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 m

…and 24 more.