PERSONA™ 42-5400-000-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00889024247642), received between Dec 9, 2019 and Aug 18, 2026 — classified as 30 injuries.

The most frequently reported specific device problem is “Noise, Audible” (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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient in a clinical study underwent an initial left total knee arthroplasty and subsequently required a cortisone injection and topical cream for iliotibial band tenderness approximately 3 months post-implantation. The patient symptoms resolved approximately 1 month later. Attempts have been made and no further information has been provided.

  Patient problems: Pain; Tendinopathy

  MAUDE report 50310427 ↗
• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND DIFFICULTY AMBULATING, REQUIRING A CANE FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 25659006 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT DEVELOPED MILD ERYTHEMA AROUND THE INCISION WITHOUT DRAINAGE. THE PATIENT WAS TREATED WITH A COURSE OF ANTIBIOTICS AS A PRECAUTION. THE ERYTHEMA SUBSEQUENTLY RESOLVED, AND THE PATIENT REPORTED SATISFACTORY RECOVERY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Erythema; Post Operative Wound Infection

  MAUDE report 24673447 ↗
• 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 23851105 ↗
• InjuryNov 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; Swelling/ Edema; Thromboembolism; Thrombosis/Thrombus

  MAUDE report 23572023 ↗
• 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 22748643 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN APPROXIMATELY TWO (2) YEARS FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT WAS INSTRUCTED TO CONTINUE OVER-THE-COUNTER PAIN-RELIEVERS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 21650725 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL ROTATING HINGE KNEE ARTHROPLASTY PERFORMED AND SUBSEQUENTLY UNDERWENT TWO REVISION SURGERIES DUE TO DISASSOCIATION OF THE HINGE POST EXTENSION. APPROXIMATELY THREE (3) WEEKS FOLLOWING THE SECOND REVISION SURGERY, THE PATIENT PRESENTED WITH SIGNIFICANT PREPATELLAR SWELLING AND UNDERWENT ADDITIONAL SURGERY TO REPAIR THE QUADRICEPS TENDON. DURING THE PROCEDURE, PREPATELLAR BURSITIS WAS REMOVED, AND TWO AREAS OF PARTIAL RUPTURE OF THE VASTUS MEDIALIS OFF THE QUADRICEPS TENDON WERE NOTED. THERE WERE NO CONCERNS WITH THE IMPLANTS WHICH WERE ALL RETAINED. THE TENDON WAS REPAIRED WITHOUT COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Bursitis; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 20523452 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL ROTATING HINGE KNEE ARTHROPLASTY PERFORMED AND SUBSEQUENTLY UNDERWENT TWO REVISION SURGERIES DUE TO DISASSOCIATION OF THE HINGE POST EXTENSION AS WELL AS A QUADRICEPS TENDON REPAIR PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS CONTINUED TO EXPERIENCE SIGNIFICANT PAIN WHICH INTERFERES WITH AMBULATION AND DAILY ACTIVITIES FOR TWO (2) YEARS FOLLOWING THE MOST RECENT PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN REPORTED TO DATE TO ADDRESS THE CONTINUED PAIN. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20523220 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND ARTHROFIBROSIS IN KNEE FIFTY FIVE DAYS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 13618645 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13595354 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE PAIN AND CREPITATION CONSISTENT WITH ARTHROFIBROSIS APPROXIMATELY SIXTEEN MONTHS POST-IMPLANTATION. THE PATIENT UNDERWENT AN ARTHROSCOPY AND DEBRIDEMENT AND NO FURTHER ISSUES HAVE BEEN REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Fibrosis; Pain

  MAUDE report 13567576 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ARTHROSCOPY OF RIGHT KNEE WITH LYSIS OF ADHESIONS APPROXIMATELY TWO MONTHS POST IMPLANTATION. PHYSICAL THERAPIST NOTICED PASSIVE PATELLAR MOBILIZATION AND RANGE OF MOTION WAS LIMITED IN RIGHT KNEE POST KNEE REPLACEMENT. STIFFNESS AND ARTHROFIBROSIS OF RIGHT KNEE WERE NOTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 13550411 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO MONTHS POST IMPLANTATION, THE PATIENT PRESENTED WITH SYMPTOMS INCLUDING PAIN, STIFFNESS, AND LIMITED RANGE OF MOTION. THE PATIENT THEN UNDERWENT A MANIPULATION UNDER ANESTHESIA WITHOUT COMPLICATION. AT THE INITIAL POST OPERATIVE VISIT, THE PATIENT EXHIBITED INCREASED RANGE OF MOTION AND SLOW RELEASE OF ADHESIONS.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13307613 ↗
• InjuryNov 29, 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; Thrombosis/Thrombus

  MAUDE report 12883847 ↗
• InjuryNov 2, 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: Loss of Range of Motion; Numbness; Pain; Swelling/ Edema

  MAUDE report 12741547 ↗
• InjuryJun 1, 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: Ambulation or Postural Difficulties; Pain

  MAUDE report 11912826 ↗
• InjuryJun 1, 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: Ambulation or Postural Difficulties; Pain

  MAUDE report 11912137 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 10 DAYS POST IMPLANTATION, THE PATIENT WAS DIAGNOSED WITH A DEEP VEIN THROMBOSIS. THE PATIENT WAS PLACED ON ELIQUIS FOR TREATMENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11739360 ↗
• InjuryApr 19, 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; Swelling/ Edema

  MAUDE report 11688888 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN ALLERGIC REACTION AND BLISTERS ON THE SURGICAL SITE SUBSEQUENT TO BILATERAL TOTAL KNEE ARTHROPLASTY. TOPICAL MEDICATIONS WERE PRESCRIBED. OUTCOME HAS SINCE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Tissue Damage

  MAUDE report 10586954 ↗
• InjuryAug 17, 2020Noise, Audible; Noise, Audible

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

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

  MAUDE report 10413134 ↗
• InjuryAug 17, 2020Noise, Audible; Noise, Audible

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: No Information

  MAUDE report 10413109 ↗
• InjuryMay 22, 2020Unstable; Unstable

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

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Swelling

  MAUDE report 10082677 ↗
• InjuryMay 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED CONTINUED DIFFICULTY WITH ACTIVITY OF DAILY LIVING, AMBULATING, SWELLING, AND STIFFNESS OVER TIME. THE PATIENT REMAINS DISSATISFIED BUT HAS RECEIVED NO FURTHER TREATMENT/INTERVENTION.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Patient Problem/Medical Problem; Swelling

  MAUDE report 10032409 ↗

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-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-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-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-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-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-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.