PERSONA® 42-5026-066-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024230408), received between Jun 1, 2020 and Sep 30, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952622 ↗
• InjuryMar 24, 2026Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening

  MAUDE report 24673954 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, 12 DAYS POST IMPLANTATION THE PATIENT PRESENTED WITH SEROUS DRAINAGE FROM THE DISTAL INCISION AND WAS PRESCRIBED AUGMENTIN. THE INCISION WAS HEALED AT THE NEXT FOLLOW-UP A MONTH LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fluid Discharge

  MAUDE report 23851086 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TKA. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY 2 YEARS LATER DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23088057 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 09-JUN-2025, A JOURNAL ARTICLE WAS RETRIEVED FROM THE KNEE (2025) THAT REPORTED A PROSPECTIVE, NON-RANDOMIZED, MULTI-CENTER STUDY FROM THE USA. THE PURPOSE OF THE STUDY WAS TO INVESTIGATE THE EARLY RADIOGRAPHIC, SURVIVAL AND CLINICAL OUTCOMES OF A CEMENTLESS TANTALUM METAL TIBIAL IMPLANT WITH A MODULAR ANATOMIC COMPONENT. THE STUDY REVIEWED 148 IMPLANTS, FROM SEVEN RESEARCH SITES, BETWEEN 2018 AND 2020. A CEMENTLESS PERSONA TRABECULAR METAL TIBIA WAS IMPLANTED IN ALL PATIENTS WITHOUT THE USE OF AUTOGRAFT BONE PASTE SLURRY. WITH REGARD TO THE TIBIAL COMPONENT, 79 PATIENTS RECEIVED A MEDIAL CONGRUENT VIVACIT-E COMPONENT, 25 PATIENTS RECEIVED A POSTERIOR STABILIZED POLYETHYLENE COMPONENT, 25 PATIENTS RECEIVED A POSTERIOR STABILIZED VIVACIT-E COMPONENT, AND 19 PATIENTS RECEIVED AN ULTRA-CONGRUENT VIVACIT-E COMPONENT. THE PATELLA WAS RESURFACED IN 92 KNEES. THE INDICATION FOR SURGERY WAS ARTHRITIS, AVASCULAR NECROSIS OF THE FEMORAL CONDYLE, POST-TRAUMATIC LOSS OF JOINT CONFIGURATION, MODERATE DEFORMITY, AND/OR THE SALVAGE OF PREVIOUSLY FAILED SURGICAL ATTEMPTS THAT DID NOT INCLUDE PARTIAL OR FULL ARTHROPLASTY OF THE IPSILATERAL KNEE. THE STUDY POPULATION HAD A MEAN AGE OF 63.3 YEARS

  Patient problems: Crepitus; Pain; Tendinopathy

  MAUDE report 22748587 ↗
• InjuryApr 17, 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: Pain

  MAUDE report 21859635 ↗
• InjuryDec 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: Failure of Implant

  MAUDE report 20912915 ↗
• InjuryMar 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, ARTHROFIBROSIS, STIFFNESS, LIMITED RANGE OF MOTION, RADIOLUCENCY AND TIBIAL AND FEMORAL IMPLANT LOOSENING APPROXIMATELY FIVE (5) YEARS FOLLOWING RIGHT KNEE ARTHROPLASTY. IN THE MONTHS AND YEARS FOLLOWING THE REVISION, THE PATIENT CONTINUED TO PROGRESS AND PAIN RESOLVED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED UNDER THE INDICATION FOR THE PROCEDURE, "THE PATIENT DID HAVE SEVERE ARTHROFIBROSIS WITH AN ARC OF MOTION OF ABOUT 40 DEGREES AS WELL AS RADIOGRAPHIC EVIDENCE OF LOOSENING OF BOTH [THE] FEMORAL AND TIBIAL COMPONENTS." DURING THE PROCEDURE, NOTES NOTED, "THERE WAS SEVERE ARTHROFIBROSIS THROUGHOUT THE ANTERIOR COMPARTMENT AS WELL AS MEDIAL AND LATERAL GUTTERS...NO BONE LOSS DURING REMOVAL OF [THE FEMORAL COMPONENT]...IT DID TAKE QUITE A BIT OF TIME TO EXPOSE THE TIBIAL COMPONENT SECONDARY TO [THE] SEVERE ARTHROFIBROSIS...THERE WERE NO FRACTURES ENCOUNTERED AND ABSOLUTELY NO BONE LOSS WAS ENCOUNTERED DURING TIBIAL COMPONENT REMOVAL." ALL COMPONENTS WERE REMOVED AND NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

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

  MAUDE report 18932271 ↗
• InjuryMar 19, 2024Adverse 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 MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS APPROXIMATELY THREE (3) MONTHS FOLLOWING RIGHT KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s); Scar Tissue

  MAUDE report 18928962 ↗
• InjuryNov 6, 2023Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A WASHOUT WITH IMPLANT RETENTION APPROXIMATELY THREE AND A HALF YEARS LATER. A FEW MONTHS AFTER THAT, THE PATIENT WAS REVISED DUE TO TIBIAL INSERT WEAR AND FEMORAL SUBSIDENCE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18079827 ↗
• InjurySep 12, 2023Adverse 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: Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17730371 ↗
• InjuryJan 18, 2023Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOURTEEN MONTHS POST IMPLANTATION DUE TO LOOSENING OF THE FEMORAL COMPONENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16193932 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 1 YEAR POST OP, THE PATIENT WAS PRESCRIBED 6 WEEKS OF PHYSICAL THERAPY DUE TO LACK OF EXTENSION, DIFFICULTY AMBULATING, ONGOING PAIN, AND WEAKNESS. THE PATIENT COMPLETED THE STUDY, ALL IMPLANTS REMAIN IN PLACE, AND NO FURTHER INTERVENTION HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain

  MAUDE report 15300954 ↗
• InjuryMar 23, 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: Insufficient Information; Unspecified Infection

  MAUDE report 11556052 ↗
• InjuryMar 19, 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: Pain

  MAUDE report 11527198 ↗
• InjuryJun 1, 2020Adverse 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 DUE TO STIFFNESS APPROXIMATELY TWO MONTHS AND ONE-WEEK POST IMPLANTATION. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Limited Mobility Of The Implanted Joint; Muscular Rigidity; Scar Tissue

  MAUDE report 10106540 ↗

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-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-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-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.