PERSONA® 42-5020-062-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024229921), received between Mar 24, 2020 and Jan 29, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Implant subsidence” (1 report).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24209035 ↗
• InjuryDec 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY ABOUT 2.5 YEARS LATER THEY HAD A REVISION DUE TO TIBIAL COMPONENT LOOSENING WITH SUBSIDENCE; THE FEMORAL COMPONENT WAS ALSO FOUND TO BE LOOSE. THE PATIENT HAD MULTIPLE PRIOR SURGERIES ON THE KNEE BEFORE THE INDEX KNEE REPLACEMENT, INCLUDING AN ACL PROCEDURE. THE PATIENT EXPERIENCED INCREASING PAIN AND SUBSEQUENTLY SUSTAINED A FALL, AFTER WHICH PAIN FURTHER INCREASED AND WAS REPORTED TO THE SURGEON. DURING THE REVISION PROCEDURE, FROZEN SECTIONS WERE TAKEN AND SHOWED NO NEUTROPHILS. BIOPSY AND CULTURES TO DATE HAVE NOT GROWN ORGANISMS. THE DIAGNOSIS WAS ASEPTIC LOOSENING. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23872516 ↗
• InjuryNov 12, 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: Hypersensitivity/Allergic reaction; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 23535244 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, SWELLING, CLICKING AND INSTABILITY AFTER A FALL APPROXIMATELY TWENTY-ONE (21) MONTHS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 23511538 ↗
• InjurySep 2, 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: Hypoxia; Pulmonary Embolism; Tachycardia

  MAUDE report 22936282 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. FIVE DAYS LATER, THE PATIENT WAS HOSPITALIZED DUE TO A PULMONARY EMBOLISM. PATIENT WAS DISCHARGED APPROXIMATELY 10 DAYS LATER AND WAS REPORTED AS RESOLVED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 22149236 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FIFTEEN MONTHS POST IMPLANTATION DUE TO LIMITED RANGE OF MOTION, STIFFNESS, SCAR TISSUE AND ADHESIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

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

  MAUDE report 16597980 ↗
• InjuryOct 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTS LIMITED FLEXION AFTER FIFTEEN MONTHS OF PHYSICAL THERAPY. NO REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: Insufficient Information; Loss of Range of Motion

  MAUDE report 15684501 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, UNDERWENT A MANIPULATION, UNDER ANESTHESIA OF THE RIGHT KNEE TWO MONTHS POST PROCEDURE, DUE TO ARTHROFIBROSIS OF THE JOINT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT DEMONSTRATED OVERALL IMPROVEMENT WITH PAIN, SATISFACTION, AND QUALITY OF LIFE AND COMPLETED THE STUDY PER PROTOCOL WITH NO FURTHER INTERVENTIONS.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 14496220 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY HAD A MANIPULATION UNDER ANESTHESIA TWO MONTHS POST PROCEDURE DUE TO STIFFNESS. COMPONENTS REMAIN IMPLANTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion

  MAUDE report 14073725 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND ARTHROFIBROSIS IN KNEE FIFTY FIVE DAYS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

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

  MAUDE report 13618633 ↗
• InjuryMay 19, 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: Damage to Ligament(s); Fall

  MAUDE report 11849960 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT UNILATERAL KNEE SURGERY. APPROXIMATELY 24 DAYS POST IMPLANTATION, THE PATIENT EXPERIENCED A PULMONARY EMBOLISM WHICH REQUIRED HOSPITALIZATION FOR 8 DAYS.

  Patient problems: Pulmonary Embolism

  MAUDE report 10472223 ↗
• InjuryMar 24, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL RIGHT KNEE ARTHROPLASTY AND BEGAN EXPERIENCING PAIN AND LIMITED MOBILITY. THE PATIENT STATES THAT X-RAYS SHOW EVERYTHING IN LINE PER PATIENTS SURGEON. THE PATIENT IS CONCERNED ABOUT A POSSIBLE ALLERGIC REACTION.

  Patient problems: Loss of Range of Motion; Pain; Patient Problem/Medical Problem; Reaction

  MAUDE report 9873723 ↗

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-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-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-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-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-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-2575-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM;
• 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.