PERSONA® 42-5020-064-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024229945), received between May 7, 2020 and Nov 5, 2025 — classified as 14 injuries, 1 malfunction.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 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: Joint Laxity

  MAUDE report 23476700 ↗
• InjurySep 3, 2025Adverse 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: Erythema

  MAUDE report 22957330 ↗
• InjuryMar 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: Ambulation or Postural Difficulties

  MAUDE report 21706682 ↗
• InjuryJan 28, 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: Cyst(s); Inflammation; Muscle/Tendon Damage; Necrosis; Pain

  MAUDE report 21254209 ↗
• MalfunctionDec 31, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT WHILE PREPARING THE IMPLANTS FOR USE, THERE WAS SIGNIFICANT PACKAGING DAMAGE OBSERVED ON BOTH THE INNER AND OUTER PLASTIC BLISTERS. THE FEMORAL COMPONENT APPEARED TO BE BULGING AGAINST THE OUTER TYVEK PEEL LAYER AND THE OUTER PEEL LAYER WAS NOTED TO BE DEBONDED AND SEPARATED. UPON OPENING THE OUTER PEEL LAYER, IT WAS NOTED THAT THE STERILE INNER PEEL LAYER HAD BEEN OPEN. THE SURGEON DECIDED TO USE ANOTHER IMPLANT DUE TO STERILITY CONCERNS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047151 ↗
• InjuryOct 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY THREE (3) YEARS POST-IMPLANTATION DUE TO IMPLANT LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20520978 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS EXPERIENCING PAIN AND STIFFNESS EIGHT MONTHS POST IMPLANTATION. ADDITIONAL PHYSICAL THERAPY AND RANGE OF MOTION MODALITIES WERE ORDERED. UPON COMPLETION OF THE STUDY AT ONE YEAR, ALL COMPONENTS REMAINED IN PLACE HOWEVER THE PATIENT REPORTEDLY UNDERWENT A PLANNED ARTHROSCOPY ON AN UNKNOWN DATE FOR POSSIBLE LYSIS OF ADHESIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint effusion; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 19606447 ↗
• InjuryApr 8, 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: Metal Related Pathology

  MAUDE report 19062625 ↗
• InjuryDec 15, 2022Adverse 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. THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH BILATERAL LOWER LOBE PNEUMONIA THROUGH CHEST X-RAY. THE PATIENT WAS PLACED ON AUGMENTIN FOR 7 DAYS. THE PNEUMONIA RESOLVED 3 WEEKS LATER WITHOUT FURTHER COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pneumonia

  MAUDE report 15990484 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY ELEVEN MONTHS POST IMPLANTATION DUE TO STIFFNESS AND ARTHROFIBROSIS.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 15164151 ↗
• InjuryFeb 7, 2022Osseointegration Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Osseointegration Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE. APPROXIMATELY EIGHT MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED FOR UNKNOWN REASONS. DURING THE SURGERY, IT WAS OBSERVED THAT THE POLYETHYLENE INSERT HAD PITTING. ALL COMPONENTS WERE EXCHANGED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 13474900 ↗
• InjuryNov 2, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 12737171 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY UNILATERAL TOTAL KNEE. APPROXIMATELY THREE WEEKS POST IMPLANTATION, THE PATIENT WAS NOTED TO HAVE DELAYED WOUND HEALING REQUIRING MEDICAL INTERVENTION.

  Patient problems: Impaired Healing; Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 10552875 ↗
• 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 10436908 ↗
• InjuryMay 7, 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: Limited Mobility Of The Implanted Joint; Pain; Patient Problem/Medical Problem; Swelling

  MAUDE report 10032406 ↗

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-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-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-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-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-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.