PERSONA™ 42-5400-000-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00889024247635), received between Apr 17, 2019 and Nov 10, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Unstable” (2 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 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: Crepitus; Extraskeletal ossification; Numbness; Pain

  MAUDE report 23509583 ↗
• InjuryNov 20, 2023Adverse 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

  MAUDE report 18170611 ↗
• 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 17469690 ↗
• InjuryJul 19, 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: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 17350519 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE DAYS POST IMPLANTATION, THE PATIENT HAD PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF PAIN. DURING EVALUATION, THE SURGEON NOTED HEMARTHROSIS OF THE REPLACED JOINT. PATIENT WAS TREATED WITH PHYSICAL THERAPY AND A NARCOTIC PAIN MEDICATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 13568723 ↗
• InjuryFeb 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  SEE H10 NARRATIVE.

  Patient problems: Failure of Implant

  MAUDE report 13474920 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, SWELLING AND DEEP VEIN THROMBOSIS FIFTEEN DAYS POST IMPLANTATION AND REQUIRED MEDICATION TO ALLEVIATE THE SYMPTOMS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Embolism/Embolus; Pain; Swelling/ Edema

  MAUDE report 13315522 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Embolism/Embolus

  MAUDE report 12960412 ↗
• 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 12837917 ↗
• InjuryOct 26, 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: Insufficient Information

  MAUDE report 12698891 ↗
• InjurySep 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INITIAL RIGHT TOTAL KNEE ARTHROPLASTY THREE YEARS AGO, SUBSEQUENTLY REVISED TWO MONTHS AGO DUE TO PAIN, SWELLING, NIGHT PAIN, AND THROBBING. THE PATELLA COMPONENT REMOVED, DUE TO LOOSENING, BUT IT WAS NOT REPLACED DUE TO POOR BONE QUALITY, AND POLY EXCHANGED WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain; Swelling/ Edema

  MAUDE report 12433452 ↗
• InjuryAug 5, 2021Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY AND DEMONSTRATED SATISFACTORY PROGRESS UNTIL THE TWO YEAR FOLLOW UP VISIT. TWO YEARS POST IMPLANTATION THE PATIENT REPORTED SEVERE PAIN, DIFFICULTY WITH DAILY ACTIVITIES, AND SWELLING. THESE SYMPTOMS PERSISTED ALONG WITH CLICKING/GRINDING THROUGH THE FOUR YEAR FOLLOW UP. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12284317 ↗
• InjuryMar 23, 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: Loss of Range of Motion; Scar Tissue

  MAUDE report 11558732 ↗
• InjuryMar 9, 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: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11445897 ↗
• InjuryMar 8, 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: Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 11435834 ↗
• InjuryDec 22, 2020Failure to Align; Failure to Align

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

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 11055416 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT RIGHT KNEE MANIPULATION UNDER ANESTHESIA APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO STIFFNESS. NO ADDITIONAL PATIENT CONSEQUENCES OR REVISIONS HAVE BEEN REPORTED.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint

  MAUDE report 10718469 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN ALLERGIC REACTION AND BLISTERS ON THE SURGICAL SITE SUBSEQUENT TO BILATERAL TOTAL KNEE ARTHROPLASTY. TOPICAL MEDICATIONS WERE PRESCRIBED. OUTCOME HAS SINCE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Tissue Damage

  MAUDE report 10592527 ↗
• InjurySep 25, 2020Adverse 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: Ambulation or Postural Difficulties; Pain; Reaction; Swelling

  MAUDE report 10586419 ↗
• InjurySep 18, 2020Adverse 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: Impaired Healing; Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 10552881 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS NOTED TO HAVE AN ACUTE PULMONARY EMBOLISM ON THREE DAYS POST-OP, FOLLOWING A PRIMARY RIGHT UNILATERAL TOTAL KNEE, REQUIRING HOSPITALIZATION AND MEDICAL INTERVENTION.

  Patient problems: Embolism; Patient Problem/Medical Problem

  MAUDE report 10436951 ↗
• InjuryMay 19, 2020Adverse 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: Muscular Rigidity; Patient Problem/Medical Problem

  MAUDE report 10069829 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 (1) YEARS POST IMPLANTATION, THE PATIENT CONTINUES TO EXPERIENCE DISCOMFORT AND ELEVATED INFLAMMATORY LABS WITH NO EFFECTS FROM INTERVENTION EFFORTS. THE PATIENT HAS BEEN INDICATED FOR A REVISION, BUT IT HAS NOT YET OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Inflammation; Pain

  MAUDE report 9539623 ↗
• InjuryOct 29, 2019Unstable; Unstable

  IT WAS REPORTED THAT APPROXIMATELY 2.5 YEARS POST IMPLANTATION, THE PATIENT IS EXPERIENCING PAIN, SWELLING, INFLAMMATION, AND INSTABILITY. THE PATIENT HAS NOW BEEN INDICATED FOR A REVISION DUE TO ASEPTIC LOOSENING.

  Patient problems: Inflammation; Pain; Swelling

  MAUDE report 9252285 ↗
• InjuryOct 29, 2019Unstable; Unstable

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

  Patient problems: Inflammation; Pain; Patient Problem/Medical Problem; Swelling

  MAUDE report 9252144 ↗

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-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-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-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-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-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
• 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

…and 24 more.