PERSONA® 42-5026-058-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024230323), received between Nov 22, 2019 and Aug 19, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 13 most recent of 13 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 50333312 ↗
• InjuryMar 26, 2026Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening

  MAUDE report 24701999 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24307576 ↗
• MalfunctionNov 12, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT, UPON OPENING THE OUTER BOX OF A FEMORAL IMPLANT TO GIVE IT TO THE NURSE, THE INNER PACKAGE APPEARED DAMAGED OR WARPED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534351 ↗
• InjuryAug 28, 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 20090588 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEVELOPED A DEEP VEIN THROMBOSIS AND WAS TREATED WITH ELIQUIS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19166596 ↗
• InjuryOct 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17923100 ↗
• InjuryDec 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT RIGHT TKA PROCEDURE. SUBSEQUENTLY THE PATIENT WAS REVISED FOR FEMORAL AND TIBIAL LOOSENING APPROXIMATELY 2 YEARS POST IMPLANTATION.

  Patient problems: Joint Laxity

  MAUDE report 15904063 ↗
• InjuryOct 26, 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 KNEE ARTHROPLASTY REVISION TO ADDRESS SIGNIFICANT INSTABILITY, DISCOMFORT, AND PAIN SECONDARY TO LATERAL LIGAMENT LAXITY IN FLEXION APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. THE PATIENT WAS REVISED TO A CONSTRAINING POST, WHICH RESTORED STABILITY AND CONFIRMED THE LATERAL LIGAMENT LAXITY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15672268 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ELEVEN MONTHS POST IMPLANTATION DUE TO INSTABILITY. THE PATIENT SUSTAINED A POSTERIOR CRUCIATE LIGAMENT INJURY AFTER A FALL RESULTING IN THE SURGEON REPLACING THE FEMUR AND ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Fall

  MAUDE report 12924252 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY AND, SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS. THE STIFFNESS WAS NOTED AS RESOLVED THE SAME DAY WITHOUT FURTHER COMPLICATION. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11273119 ↗
• 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 9539608 ↗
• InjuryNov 22, 2019Loosening 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: No Code Available

  MAUDE report 9362408 ↗

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-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-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-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

…and 24 more.