PERSONA® Natural Tibia® 42-5320-064-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00889024471016), received between Jan 6, 2020 and May 19, 2025 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (10 reports).

40 other recalls cover devices cleared under the same FDA submission (K113369, K122765, 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO IMPLANT LOOSENING OF BOTH COMPONENTS. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 22045995 ↗
• InjuryMay 13, 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: Ambulation or Postural Difficulties; Pain; Synovitis

  MAUDE report 22008831 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING WEAKNESS, IMBALANCE, SWELLING, AND ACHING IN THE KNEE POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 22005363 ↗
• InjuryMar 12, 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: Bone Fracture(s)

  MAUDE report 21585197 ↗
• InjuryDec 30, 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; Pain

  MAUDE report 21036121 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A POST-OPERATIVE DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. SUBSEQUENTLY, AT THE TWO YEAR FOLLOW-UP, THE PATIENT REPORTED INCREASING KNEE PAIN WITH TIGHTNESS AND SPASMS. THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY AND INSTRUCTED TO MONITOR WATER AND ELECTROLYTE INTAKE. ALL IMPLANTS REMAIN IN PLACE AND IF THE SYMPTOMS PERSIST, WILL CONSIDER A FURTHER EVALUATION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED

  Patient problems: Cramp(s) /Muscle Spasm(s); Joint effusion; Pain; Swelling/ Edema

  MAUDE report 20517412 ↗
• InjurySep 26, 2024Loss 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 SIX AND A HALF MONTHS POST IMPLANTATION DUE TO TIBIAL FRACTURE CAUSED BY A FALL THAT SUBSEQUENTLY CAUSED LOOSENING OF THE TIBIAL IMPLANT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 20311601 ↗
• MalfunctionSep 12, 2024Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206479 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND DIFFICULTY AMBULATING UNABLE TO BEAR WEIGHT POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20127355 ↗
• InjuryJun 4, 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: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Subluxation; Swelling/ Edema

  MAUDE report 19461961 ↗
• InjuryMay 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO TIBIAL TRAY LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19330305 ↗
• InjuryApr 9, 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: Ambulation or Postural Difficulties; Pain

  MAUDE report 19072118 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A PERI PROSTHETIC FRACTURE NEAR THE TIBIAL IMPLANT. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 19041709 ↗
• InjurySep 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL LOOSENING APPROXIMATELY FIFTEEN (15) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17740212 ↗
• InjuryMay 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16875607 ↗
• InjuryMar 21, 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: Loss of Range of Motion; Nerve Damage; Pain; Swelling/ Edema

  MAUDE report 16585853 ↗
• InjuryFeb 17, 2023Adverse 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 APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO LIMITED ROM, DISCOMFORT, AND ISSUES COMPLETING ADLS. INCREASED FLEXION AND EXTENSION WERE ACHIEVED, AND ALL COMPONENTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

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

  MAUDE report 16397834 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAS DEVELOPED COMPLEX REGIONAL PAIN SYNDROME EXPERIENCING PAIN, SWELLING, DIFFICULTIES WITH ROM, AND HYPERSENSITIVITY APPROXIMATELY TWO YEARS POST IMPLANTATION ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Hyperresponsive to stimuli; Pain; Swelling/ Edema

  MAUDE report 16378189 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD SUBCUTANEOUS ABSCESS ONE MONTH POST IMPLANTATION. CLEANING WAS PERFORMED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Abscess

  MAUDE report 15967759 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TKA. APPROXIMATELY 5.5 WEEKS LATER, THE PATIENT PRESENTED AT THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AND RIGHT FLANK PAIN. BILATERAL PULMONARY EMBOLISMS WERE DIAGNOSED ON CT AND LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS CONFIRMED BY ULTRASOUND. THE PATIENT WAS PLACED ON ADDITIONAL ANTICOAGULANTS AND DISCHARGED THE NEXT DAY. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 15923883 ↗
• InjurySep 20, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY APPROXIMATELY 3.5 YEARS POST IMPLANTATION DUE TO LOOSENING.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 15454775 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY 14 MONTHS AGO. SUBSEQUENTLY, PATIENT HAD NO ISSUES IMMEDIATE POST OP BUT STARTED TO EXPERIENCE SWELLING AND STIFFNESS/TIGHTNESS SHORTLY AFTER. PATIENT HAD DIFFICULTY WALKING, STANDING, GETTING UP AND DOWN FROM SITTING POSITION. PATIENT WAS ABLE TO WALK UP TO ONE MILE. PATIENT UNDERWENT AN ASPIRATION TO REMOVE FLUID APPROXIMATELY 6 MONTHS AGO AND GOT NO RELIEF. APPROXIMATELY 3 MONTHS AGO SYMPTOMS STARTED TO GET WORSE; PATIENT WAS NOW EXPERIENCING PAIN AND CAN'T STAND FOR MORE THAN 10 MIN, CAN'T GET UP AND DOWN, CAN'T BEND KNEE, CAN'T WALK ANY DISTANCE WITHOUT PAIN. PATIENT UNDERWENT SECOND ASPIRATION LAST MONTH AND FLUID WAS SENT FOR TESTING FOR INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 13337733 ↗
• InjuryNov 1, 2021Loss 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

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 12729460 ↗
• InjuryAug 17, 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: Ambulation or Postural Difficulties; Failure of Implant; Insufficient Information; Pain

  MAUDE report 12332770 ↗
• InjuryOct 28, 2020Adverse 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: Muscular Rigidity; Pain; Swelling

  MAUDE report 10752925 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113369, K122765, K172524. One submission often covers many models, so check the product and lot details in each record.

• Z-1224-2018 · Dec 12, 2017 · Terminated
  PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumati
• 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-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-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-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-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

…and 25 more.