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

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024643710), received between Mar 25, 2022 and Mar 5, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 8 WEEKS POST-OP,THE PATIENT HAD A FLEXION CONTRACTURE WITH A RANGE OF MOTION OF 13-106 DEGREES AND DEVELOPED ARTHROFIBROSIS. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA. POSTOPERATIVELY, FULL EXTENSION WAS ACHIEVED AND FLEXION EXCEED 130 DEGREES WITH NO COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ankylosis; Loss of Range of Motion; Scar Tissue

  MAUDE report 24518041 ↗
• InjuryDec 29, 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 23906066 ↗
• InjuryNov 21, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617872 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A STUDY THAT APPROXIMATELY 1 MONTH POST IMPLANTATION OF A LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS DIAGNOSED WITH CELLULITIS AND WAS PRESCRIBED ANTIBIOTICS, AS WELL AS UNDERWENT A WOUND DEBRIDEMENT, IRRIGATION, AND WOUND CARE. THE PATIENT WAS REPORTED AS FULLY HEALED APPROXIMATELY 6 WEEKS LATER. DEVICES REMAIN IMPLANTED. ATTEMPTS WERE MADE AND ALL AVAILABLE INFORMATION WAS PROVIDED.

  Patient problems: Cellulitis

  MAUDE report 22668488 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SWELLING AND OTHER UNSPECIFIED POST-OPERATIVE COMPLICATIONS APPROXIMATELY FOUR (4) YEARS FOLLOWING RIGHT KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Swelling/ Edema

  MAUDE report 21731131 ↗
• InjuryJan 28, 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: Cyst(s); Inflammation; Muscle/Tendon Damage; Necrosis; Pain

  MAUDE report 21254200 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL BILATERAL KNEE ARTHROPLASTY. THE PATIENT REPORTS CHRONIC ISSUES WITH BOTH KNEES INCLUDING PAN AND SWELLING. THE PATIENT HAD AN MRI WITH FINDINGS OF BONE NECROSIS, QUADRICEPS AND PATELLA TENDINOSIS, PATELLAR TENDON PERFORATION, AND MODERATE EFFUSION. THE DEVICES REMAIN IMPLANTED AT THIS TIME.

  Patient problems: Inflammation; Muscle/Tendon Damage; Necrosis; Pain

  MAUDE report 21245613 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 16 DAYS POST-OP, THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC FOR MILD REDNESS TO PROXIMAL INCISION AS A PROPHYLAXIS TREATMENT AND IT RESOLVED WITH NO FURTHER ALLEGATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Erythema; Post Operative Wound Infection

  MAUDE report 21036275 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DRAINAGE FROM THE INCISION APPROXIMATELY THREE (3) MONTHS FOLLOWING A LEFT KNEE ARTHROPLASTY. THE PATIENT WAS INSTRUCTED TO APPLY ANTIBIOTIC OINTMENT, KEEP THE INCISION COVERED AND WAS PRESCRIBED AN ANTIBIOTIC PROPHYLACTICALLY. THE PATIENT'S DRAINAGE WAS REPORTEDLY RESOLVED SEVEN (7) MONTHS LATER. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Impaired Healing

  MAUDE report 20534053 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS THAT WAS IMPACTING ROM FROM ADHESIONS & SCAR TISSUE. PATIENT REMAINS IMPLANTED. PATIENT REPORTS SWOLLEN AND HOT TO THE TOUCH WITH LIMITED RANGE OF MOTION. ONE MONTH LATER, KNEE WAS ASPIRATED FOR RECURRENT PAIN, SWELLING, AND WARMTH PERFORMED. UPON EXAM PERFORMED BY NEW DOCTOR NOTED EFFUSION, MILD PAIN WITH ROM, TENDER TO PALPATION, MODERATE LAXITY WITH VARUS/VALGUS STRESS TEST AND ANTERIOR DRAWER. PATIENT REPORTS LOOSENING AT LAST OFFICE VISIT.

  Patient problems: Adhesion(s); Alteration in Body Temperature; Loss of Range of Motion; Scar Tissue; Swelling/ Edema; Unspecified Infection

  MAUDE report 20301113 ↗
• InjuryMay 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT WAS HOSPITALIZED TWO DAYS POST IMPLANTATION FOR PNEUMONIA, CLOSTRIDIOIDES DIFFICILE (C. DIFF) COLITIS, AND SEPSIS. TREATED WITH OXYGEN, ORAL VANCOMYCIN, IV CEFEPIME, ORAL FLAGYL, IV FLUIDS WERE ADMINISTERED. AFTER ADMISSION, THE PATIENT BEGAN DEVELOPING RECURRENT FEVERS WITH NO APPARENT CAUSE. A CT REVEALED A PULMONARY EMBOLISM AND SO THE PATIENT WAS STARTED ON IV HEPARIN. THE PATIENT'S OUTCOME HAS NOT RESOLVED AND IS ONGOING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pneumonia; Pulmonary Embolism

  MAUDE report 19415517 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN IN KNEE AND UNABLE TO STAND OR WALK FOR JUST A FEW MINUTES THREE YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17469716 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA STUDY A PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, SWELLING, DECREASED RANGE OF MOTION, DIFFICULTY WITH MOBILITY, AND A BAKER¿S CYST ALSO FORMED. SUBSEQUENTLY, APPROXIMATELY FIVE MONTHS LATER, THE PATIENT UNDERWENT AN ARTHROSCOPIC PROCEDURE FOR LYSIS OF SCAR TISSUE AND ADHESIONS AS WELL AS DRAINAGE OF THE CYST. AT THE ONE YEAR CHECK-UP ALL THE KNEE COMPONENTS REMAIN IN PLACE AND THE PATIENT IS REPORTEDLY NOW DOING WELL WITH NO FURTHER COMPLICATIONS KNOWN.

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

  MAUDE report 17383594 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY WAS PERFORMED. SUBSEQUENTLY, APPROXIMATELY 2 MONTHS POST PROCEDURE, THE PATIENT HAD A PARTIAL WOUND DEHISCENCE, RESULTING IN EXTENSIVE WOUND CARE AND DELAYING FUNCTIONAL RECOVERY. THE PATIENT WAS PLACED ON RANGE OF MOTION RESTRICTIONS TO ALLOW WOUND HEALING. AFTER FULL HEALING OF THE WOUND OCCURRED, PHYSICAL THERAPY AND MANIPULATION OF THE JOINT RESUMED TO RESTORE FULL FUNCTION. THE PATIENT REMAINS SATISFIED WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Loss of Range of Motion; Pain; Wound Dehiscence

  MAUDE report 17169723 ↗
• InjuryMay 9, 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: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 16896392 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 16548147 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA TWO MONTHS POST IMPLANTATION DUE TO LIMITED RANGE OF MOTION AND STIFFNESS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 15948768 ↗
• InjurySep 2, 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 TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 5 DAYS POST IMPLANTATION, THE PATIENT DEVELOPED RIGHT FOOT DROP AND WAS PRESCRIBED PHYSICAL THERAPY AND AN ANKLE FOOT ORTHOSIS BRACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 15348137 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING KNEE PAIN FOLLOWING RIGHT KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 15166123 ↗
• InjuryJul 15, 2022Unstable; Unstable

  IT WAS REPORTED A PATIENT WAS CONVERTED FROM A RIGHT MEDIAL UNCOMPARTMENTALIZED KNEE TO A RIGHT TOTAL KNEE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING ONGOING PAIN, SWELLING, RADIOLUCENCY AT THE MEDIAL TIBIAL PLATEAU, AND POSSIBLE INSTABILITY. ANTI-INFLAMMATORY GEL AND STEROIDS WERE PRESCRIBED TO RELIEVE THE SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema; Weight Changes

  MAUDE report 15026362 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS, WOUND DEHISCENCE AND LIMITED FLEXION IN KNEE TWO MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Scar Tissue

  MAUDE report 14237924 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. OPERATIVE NOTES FROM THE MANIPULATION NOTED ARTHROFIBROSIS, INTRAARTICULAR SCAR WITH IMPINGEMENT AND CHRONIC SYNOVITIS. AN ARTHROSCOPY WITH A SYNOVECTOMY WAS PERFORMED AND THE PATIENT'S RANGE OF MOTION INCREASED FROM 0-110° TO 0-130° DURING THE MANIPULATION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Adhesion(s); Scar Tissue; Synovitis; Unspecified Tissue Injury

  MAUDE report 13910131 ↗

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-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-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-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.