PERSONA® Natural Tibia® 42-5320-064-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00889024471023), received between Jan 6, 2020 and Sep 22, 2026 — classified as 23 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 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 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Implant subsidence

  Patient problems: Joint Laxity

  MAUDE report 50859875 ↗
• InjurySep 22, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Patient problems: Aseptic loosening

  MAUDE report 50857621 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an initial right total knee arthroplasty. Two weeks following the initial physical therapy treatment, the patient began to experience a sudden onset of intense pain after waking up. Subsequently, the patient underwent two (2) additional rounds of physical therapy. Four (4) months post-implantation, the patient continues to have pain and decreased range of motion. Due diligence is in progress for this event; to date all available information has been provided.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 50333306 ↗
• InjuryApr 24, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA. SUBSEQUENTLY, THEY HAD A REVISION DUE TO TIBIAL LOOSENING APPROXIMATELY 4 YEARS POST-OP. SURGICAL TECHNIQUE WAS UTILIZED. THE TIBIAL COMPONENT WAS REVISED USING A STEMMED CONSTRUCT WITH AUGMENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 24979989 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 24232837 ↗
• InjuryDec 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence

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

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23872519 ↗
• InjuryAug 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS CONTINUED PAIN, INSTABILITY, AND SUBSIDENCE OF THE TIBIAL COMPONENT APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. CLINICAL NOTES FROM THE PATIENT'S INITIAL PROCEDURE NOTED NO INTRAOPERATIVE COMPLICATIONS. CLINICAL NOTES FROM THE PATIENT'S REVISION NOTED THE TIBIAL STEM HAD SUBSIDED AND MIGRATED LATERALLY WITH A DEFECT LATERALLY IN THE PROXIMAL TIBIA. THE FEMORAL COMPONENT WAS FOUND TO BE STABLE AND WAS RETAINED AS WELL AS THE PATELLA. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Aseptic loosening; Joint Laxity; Muscle Weakness/Atrophy; Pain

  MAUDE report 22841229 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PROGRESSIVE PERSISTENT PAIN AND WAS PRESCRIBED MEDICATION APPROXIMATELY TWO YEARS AND THREE MONTHS POST IMPLANTATION. THE PATIENT WAS PRESCRIBED MEDROL DOS PAK AND THE ISSUE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22131016 ↗
• InjuryMay 21, 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 COMPONENT LOOSENING APPROXIMATELY ELEVEN (11) MONTHS FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 22063076 ↗
• InjuryApr 24, 2025Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOUR YEARS AND EIGHT MONTHS POST IMPLANTATION DUE TO TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Aseptic loosening; Insufficient Information

  MAUDE report 21901798 ↗
• InjurySep 9, 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 20174074 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 1.5 YEARS POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 17640947 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTS PAIN AND SWELLING AND THAT THEY CANNOT BEND THEIR KNEE WELL. THE PATIENT ALSO HAS A BAKER'S CYST ON THE BACK OF THE KNEE THAT STARTED ABOUT 4 WEEKS POST-OP AND HAS BEEN PRESCRIBED ANTIBIOTICS ON AND OFF SINCE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 17152201 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVEN YEARS POST IMPLANTATION DUE TO PAIN AND TIBIAL LOOSENING. THE PATIENT WAS SUSPECTED AND TREATED FOR SUBCLINICAL OCCULT INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Pain; Scar Tissue; Subclinical Infection

  MAUDE report 15530862 ↗
• MalfunctionSep 12, 2022Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth; Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED. SURGEON HAD A HARD TIME TO INSERT AN ARTICULAR SURFACE IN TIBIA PLATE. SO, HE PRESSED THE ARTICULAR SURFACE TO THE TIBIA PLATE. AT THE SAME TIME, THE TIBIAL PLATE, WHICH WAS FIXED WITH CEMENT, MOVED WITH THE PATIENT TIBIA BONE. AND THE TIBIA CEMENT FIXATION LOOSENED. A SECOND TIBIA WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 15402187 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ILIOTIBIAL BAND TENDONITIS WITH PAIN AND DISCOMFORT APPROXIMATELY ONE (1) YEAR FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS TREATED CONSERVATIVELY WITH A CORTISONE INJECTION AND PRESCRIBED PHYSICAL THERAPY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Failure of Implant; Inflammation; Pain

  MAUDE report 14852047 ↗
• InjuryJun 1, 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 KNEE ARTHROPLASTY REVISION TO ADDRESS A DEEP, STAPHYLOCOCCUS HOMINIS AND STAPHYLOCOCCUS EPIDERMIDIS INFECTION SEVENTEEN (17) DAYS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection

  MAUDE report 14564314 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ONE YEAR POST IMPLANTATION DUE TO PAIN, TIGHTNESS WITH RANGE OF MOTION, AND POSSIBLE LOOSENING ON IMAGING. OPERATIVE REPORT NOTES NO COMPONENT LOOSENING FOUND. TIBIAL PROSTHESIS WAS REPLACED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 14250755 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED A DEEP VEIN THROMBOSIS ONE WEEK POSTOP. THE COMPLICATION RESOLVED TWO WEEKS LATER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12636385 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY AND DEMONSTRATED SATISFACTORY PROGRESS UNTIL THE TWO YEAR FOLLOW UP VISIT. TWO YEARS POST IMPLANTATION THE PATIENT REPORTED SEVERE PAIN, DIFFICULTY WITH DAILY ACTIVITIES, AND SWELLING. THESE SYMPTOMS PERSISTED ALONG WITH CLICKING/GRINDING THROUGH THE FOUR YEAR FOLLOW UP. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12284278 ↗
• InjuryMar 23, 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: Unspecified Infection

  MAUDE report 11556009 ↗
• MalfunctionMar 18, 2021Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515190 ↗
• InjuryDec 22, 2020Failure to Align; Failure to Align

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

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 11055411 ↗
• InjuryFeb 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: Limited Mobility Of The Implanted Joint; Muscular Rigidity; Pain; Patient Problem/Medical Problem

  MAUDE report 9768961 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST IMPLANTATION, THE PATIENT HAD COMPLAINTS OF SEVERE PAIN, DIFFICULTY WITH ADLS AND STIFFNESS. AT 1 YEAR POST OP, HETEROTOPIC OSSIFICATION WAS IDENTIFIED ON AN X-RAY. THERE HAS BEEN NO REPORT OF ANY INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion; Pain

  MAUDE report 9553192 ↗

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-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-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
• Z-2577-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12

…and 25 more.