PERSONA® 42-5026-070-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024230439), received between Mar 13, 2020 and May 13, 2026 — classified as 12 injuries.

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

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1 PATIENT IN THE CONVENTIONAL GROUP EXPERIENCED POSTOP WOUND LEAKAGE LEADING TO PROLONGED HOSPITAL STAY OF 1 DAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fluid Discharge

  MAUDE report 25163391 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion

  MAUDE report 24495215 ↗
• InjurySep 30, 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: Cellulitis; Inflammation

  MAUDE report 20333115 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT COMPLETED MULTIPLE PT SESSIONS WITHOUT IMPROVEMENT IN ROM AND COMPLAINED OF STIFFNESS AND DIFFICULTY AMBULATING. OPEN ARTHROLYSIS WITH REVISION OF THE FEMORAL COMPONENT AND REPLACEMENT OF THE ARTICULAR SURFACE OCCURRED NINE MONTHS POST IMPLANTATION WITHOUT ANY KNOWN COMPLICATIONS. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Loss of Range of Motion

  MAUDE report 18940146 ↗
• InjuryMar 12, 2024Loosening 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: Adhesion(s); Joint Impingement; Joint effusion; Loss of Range of Motion; Pain; Radiolucent Lines; Scar Tissue; Swelling/ Edema

  MAUDE report 18890592 ↗
• InjuryAug 10, 2022Unstable; Noise, Audible; Unstable; Noise, Audible

  IT WAS REPORTED THE PATIENT IS REPORTING PAIN, SWELLING, INSTABILITY, AND AN AUDIBLE CLICKING NOISE APPROXIMATELY 4 YEARS POST IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. HOWEVER; NO MORE IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15197946 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT THE PATIENT UNDERWENT A LEFT KNEE PROCEDURE. SUBSEQUENTLY, 2 YEARS 6 MONTHS POST PROCEDURE, THE PATIENT HAS PAIN IN THE LEFT KNEE. ATTEMPTS TO GATHER ADDITIONAL INFORMATION ARE UNDERWAY. HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14945020 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS APPROXIMATELY THREE (3) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 14110842 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS APPROXIMATELY THREE (3) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 14110833 ↗
• InjuryJun 3, 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; Loss of Range of Motion; Scar Tissue

  MAUDE report 11929608 ↗
• InjuryMar 30, 2020Unstable; Unstable

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

  Patient problems: Bruise/Contusion; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 9899244 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STUDY PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY AND WAS DIAGNOSED WITH A RIGHT LOWER EXTREMITY DVT LESS THAN THREE MONTHS POST-OP. MEDICAL INTERVENTION OCCURRED, AND THE OUTCOME HAS BEEN NOTED AS RESOLVED.

  Patient problems: Embolism

  MAUDE report 9829657 ↗

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-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-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

…and 24 more.