PERSONA® 42-5400-000-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024643697), received between Aug 17, 2022 and Aug 19, 2026 — classified as 16 injuries.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an initial right total knee arthroplasty. Two weeks following the initial physical therapy treatment, the patient began to experience a sudden onset of intense pain after waking up. Subsequently, the patient underwent two (2) additional rounds of physical therapy. Four (4) months post-implantation, the patient continues to have pain and decreased range of motion. Due diligence is in progress for this event; to date all available information has been provided.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 50333314 ↗
• InjurySep 3, 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: Erythema

  MAUDE report 22957339 ↗
• 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 22936890 ↗
• 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 22149133 ↗
• InjuryFeb 18, 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: Loss of Range of Motion

  MAUDE report 21394690 ↗
• InjuryDec 4, 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: Pain

  MAUDE report 20847313 ↗
• InjuryNov 27, 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: Loss of Range of Motion

  MAUDE report 20798075 ↗
• InjuryMay 21, 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: Pain

  MAUDE report 19360316 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ABOUT 2 YEARS TWO MONTHS POST PROCEDURE THE PATIENT FELL FOR UNKNOWN REASONS, CAUSING PAIN AND SWELLING. PATIENT WAS SEEN IN THE OFFICE WHERE KNEE WAS ASPIRATED WITHOUT COMPLICATION.

  Patient problems: Fall; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 16914654 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO LIMITED RANGE OF MOTION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16859986 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, SWELLING, DAMAGED NERVE AND RANGE OF MOTION POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Nerve Damage; Pain; Swelling/ Edema

  MAUDE report 16585959 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT HAD A MANIPULATION UNDER ANESTHESIA ON AN UNKNOWN DATE DUE TO ARTHROFIBROSIS, STIFFNESS, PAIN, AND DECREASED ROM. PATIENT NOW REPORTS SWELLING SINCE ARTHROSCOPY. SUBSEQUENTLY 1ST STAGE REVISION DUE TO SUSPECTED INFECTION. DURING THE PROCEDURE NOTED SCAR TISSUE AND EROSIVE CHANGES TO THE MEDIAL TIBIA. ALL COMPONENTS AND CEMENT REMOVED. NAIL AND ANTIBIOTIC CEMENT IMPLANTED WITHOUT COMPLICATIONS.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16521255 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT HAD A MANIPULATION UNDER ANESTHESIA ON AN UNKNOWN DATE DUE TO ARTHROFIBROSIS, STIFFNESS, PAIN, AND DECREASED ROM. THICK ABUNDANT SCAR TISSUE WAS EXCISED THROUGHOUT THE JOINT. UNFORTUNATELY SYMPTOMS CONTINUED WITH ADDITION OF SWELLING. KNEE ASPIRATION X 2 WITH NO GROWTH REPORTED AND NEGATIVE FOR INFECTION.

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

  MAUDE report 16521049 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO LIMITED ROM, DISCOMFORT, AND ISSUES COMPLETING ADLS. INCREASED FLEXION AND EXTENSION WERE ACHIEVED, AND ALL COMPONENTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

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

  MAUDE report 16397833 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAS DEVELOPED COMPLEX REGIONAL PAIN SYNDROME EXPERIENCING PAIN, SWELLING, DIFFICULTIES WITH ROM, AND HYPERSENSITIVITY APPROXIMATELY TWO YEARS POST IMPLANTATION ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Hyperresponsive to stimuli; Pain; Swelling/ Edema

  MAUDE report 16378192 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA STUDY THAT THE PATIENT DEVELOPED A PULMONARY EMBOLISM REQUIRING HOSPITALIZATION APPROXIMATELY FORTY (40) DAYS POST IMPLANTATION. NO FURTHER INTERVENTIONS HAVE BEEN REPORTED.

  Patient problems: Pulmonary Embolism

  MAUDE report 15244881 ↗

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-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-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-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
• 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;

…and 24 more.