PERSONA® 42-5026-062-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024230354), received between Jul 12, 2021 and Jan 5, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23957404 ↗
• MalfunctionNov 19, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT WHEN OPENING THE CR LEFT SIZE 7 NARROW FEMUR IMPLANT PACKAGING, IT WAS OBSERVED THAT THE PAPER SEAL ON THE OUTER PLASTIC TRAY (WHICH CONTAINS THE INNER PLASTIC TRAY HOLDING THE IMPLANT) WAS NOT FIRMLY ATTACHED. THE OUTER PLASTIC WRAP WAS INTACT, AND THE IMPLANT WAS NOT USED AND NEVER ENTERED THE STERILE FIELD. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597249 ↗
• InjuryFeb 3, 2025Migration; Migration

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE THREE WEEKS POST IMPLANTATION DUE TO KNEE SUBLUXING BACKWARDS. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Subluxation

  MAUDE report 21293570 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE SURGERY. SUBSEQUENTLY, THE PATIENT HAD 95 DEGREE FLEXION AND 10 DEGREE EXTENSION WITH MEDIAL SIDE TIGHTNESS AND WAS REVISED APPROXIMATELY 7 MONTHS POST-OP DUE TO MODERATE LIMITED RANGE OF MOTION. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 21233288 ↗
• InjuryDec 12, 2024Unstable; Unstable

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912938 ↗
• InjuryMar 25, 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: Pain

  MAUDE report 18967843 ↗
• InjuryJun 6, 2023Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY AND THEY INITIALLY RECOVERED WELL WITH SOME MILD KNEE PAIN AND PERSISTENT SWELLING. AFTER A FEW MONTHS, THE PATIENT WAS ABLE TO RETURN TO THE GYM, HOWEVER, THEY EXPERIENCED INCREASED RECURRENT LEFT KNEE PAIN. THE PATIENT ALSO REPORTED ASSOCIATED STIFFNESS AND A 'CATCHING' SENSATION WITH EXTENSION. THEY STATED THAT THE SYMPTOMS ARE WORSE WITH WEIGHTBEARING ACTIVITIES AND CAUSE SOME INSTABILITY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 5 YEARS LATER AND IT WAS NOTED DURING THE REVISION THAT THE FEMORAL COMPONENT WAS LOOSE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17071147 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

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

  MAUDE report 14437452 ↗
• InjuryMay 19, 2022Unstable; Unstable

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY, LOWERED JOINT LINE, AND POOR PATELLA TRACKING.

  Patient problems: Failure of Implant

  MAUDE report 14435717 ↗
• InjuryMay 10, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT A PATIENT EXPERIENCED LEFT KNEE PAIN AND CLICKING THAT REQUIRED MEDICAL INTERVENTION APPROXIMATELY TEN MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 14349306 ↗
• InjuryMar 10, 2022Unintended Movement; Unintended Movement

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

  Patient problems: Adhesion(s); Scar Tissue

  MAUDE report 13720967 ↗
• InjuryJul 12, 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: Pain

  MAUDE report 12154628 ↗

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-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-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-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-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-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.