PERSONA® Natural Tibia® 42-5320-071-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00889024471061), received between Oct 29, 2019 and Aug 24, 2026 — classified as 60 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (18 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 64 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a total knee arthroplasty, vascular bleeding occurred immediately after implantation upon tourniquet release due to injury to the popliteal artery. The bleeding was identified intra-operatively after tourniquet deflation, haemostasis was performed, and the components that had been placed were removed during the same procedure, adding an additional two hours to the procedure. The patient was revised seven days later. Attempts have been made and no further information has been provided.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 50411510 ↗
• InjuryAug 6, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that a patient was revised approximately five years eleven and half months post implantation due to pain and tibial loosening. There is no additional information available.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 50157880 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent an initial right total knee arthroplasty. Subsequently, approximately five months post-implantation, the patient received a bupivacaine injection for pes anserinus bursitis and iliotibial band tendonitis. The patient experienced resolution of symptoms and reported being satisfied with the outcome. Attempts have been made and no further information has been provided.

  Patient problems: Bursitis; Tendinopathy

  MAUDE report 50017532 ↗
• MalfunctionJun 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT WHEN THE TIBIAL TRAY WAS OPENED, AN UNKNOWN RESIDUE WAS IDENTIFIED ON THE SURFACE OF THE IMPLANT. NO ABNORMALITIES WERE IDENTIFIED WITH THE IMPLANT PACKAGING. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627979 ↗
• InjuryJun 5, 2026Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY, THE SURGEON DESCRIBED DIFFICULTY INSERTING THE BEARING ONTO THE TIBIAL TRAY. HE SUGGESTED THAT WHEN USING THE INSERTER, IT APPEARED THAT A PIECE OF METAL SHEARED OFF AND WAS CAUSING THE POLY TO NOT SIT INTO THE TIBIA CORRECTLY. AS THE TIBIA WAS ALREADY CEMENTED IN SITU, THE PIECE WAS UNABLE TO BE RETRIEVED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25408051 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A JOURNAL ARTICLE THAT 1 PATIENT IN THE CONVENTIONAL GROUP EXPERIENCED POSTOP WOUND LEAKAGE, LEADING TO PROLONGED HOSPITAL STAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fluid Discharge

  MAUDE report 25176915 ↗
• InjuryFeb 25, 2026Migration or Expulsion of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO UNKNOWN COMPLICATIONS. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Crepitus; Insufficient Information; Joint Laxity; Loss of Range of Motion; Pain; Radiolucent Lines; Swelling/ Edema

  MAUDE report 24447115 ↗
• InjuryOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO THE STEM HAVING DISLODGED FROM THE TIBIAL TRAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 23435784 ↗
• InjurySep 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL TKA. SUBSEQUENTLY, ABOUT 3 YEARS LATER PATIENT HAD BEEN HAVING PAIN AND POOR ROM, A REVISION OF TIBIAL COMPONENT DUE TO PAIN, UNDERSIZED AND QUERY LOOSE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain

  MAUDE report 23027572 ↗
• InjuryAug 28, 2025Loss 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: Aseptic loosening; Joint Impingement

  MAUDE report 22911399 ↗
• InjuryAug 26, 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 RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO (2) YEARS AND TWO (2) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. THE TIBIAL TRAY AND ARTICULAR SURFACE WERE REPLACED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 22893395 ↗
• InjuryFeb 21, 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 RIGHT KNEE PROCEDURE. SUBSEQUENTLY, SYNOVITIS WAS NOTED AND CULTURES WERE PERFORMED AND THE PATIENT WAS REVISED APPROXIMATELY 1.5 YEARS POST-OP DUE TO INSTABILITY AND ASEPTIC LOOSENING. ALL COMPONENTS WERE REVISED. IT WAS NOTED THAT THERE WAS NO CEMENT ON THE TIBIAL IMPLANT OR ON THE BONE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Synovitis

  MAUDE report 21432487 ↗
• InjuryFeb 4, 2025Loosening 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 TIBIAL LOOSENING APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Failure of Implant; Pain; Radiolucent Lines; Swelling/ Edema

  MAUDE report 21302918 ↗
• MalfunctionFeb 3, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE HAD DIFFICULTY SEATING INTO THE TIBIAL TRAY, AND THE FRONT EDGE WAS SITTING PROUD. ADDITIONAL FORCE WAS APPLIED, AND THE ARTICULAR SURFACE SEATED FULLY INTO THE TRAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290924 ↗
• InjuryJan 28, 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: Cyst(s); Inflammation; Muscle/Tendon Damage; Necrosis; Pain

  MAUDE report 21254208 ↗
• InjuryJan 6, 2025Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO UNKNOWN REASON. GROSS TIBIA FAILURE AND PITTING WAS NOTICED ON THE ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 21079453 ↗
• InjuryDec 11, 2024Malposition of Device; Malposition of Device

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

  Patient problems: Failure of Implant

  MAUDE report 20901898 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  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; Failure of Implant; Loss of Range of Motion; Scar Tissue; Swelling/ Edema; Unspecified Infection

  MAUDE report 20301075 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Joint Laxity

  MAUDE report 20283426 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWENTY MONTHS POST IMPLANTATION DUE TO PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19689405 ↗
• InjuryJun 25, 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: Joint effusion; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 19606456 ↗
• InjuryApr 17, 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: Inflammation; Swelling/ Edema

  MAUDE report 19124180 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TEN MONTHS POST IMPLANTATION DUE TO METAL ALLERGY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Metal Related Pathology

  MAUDE report 19086489 ↗
• InjuryApr 4, 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

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

  Patient problems: Bone Fracture(s)

  MAUDE report 19045126 ↗
• InjuryJan 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO TIBIA LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18503362 ↗

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-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-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-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;

…and 25 more.