PERSONA® Natural Tibia® 42-5320-079-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00889024471108), received between Oct 8, 2019 and Mar 24, 2026 — classified as 26 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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.

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

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

  Patient problems: Erythema; Post Operative Wound Infection

  MAUDE report 24679928 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Loss of Range of Motion

  MAUDE report 24613408 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT UNDERWENT THE FIRST STAGE OF A TWO STAGE REVISION DUE TO A MSSA INFECTION ON AN UNKNOWN DATE. DURING STAGE I, THE PATIENT WAS IMPLANTED WITH AN UNKNOWN CEMENT SPACER WHICH WAS REVISED DURING STAGE 2 TO A ROTATING HINGE CONSTRUCT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 22588591 ↗
• InjuryMay 1, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REVISION SURGERY ONE YEAR FOUR MONTHS POST IMPLANTATION DUE TO MALROTATION OF THE FEMORAL AND TIBIAL COMPONENTS. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21945196 ↗
• 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 21731098 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT BEGAN TO EXPERIENCE PAIN, WARMTH, EFFUSION, AND DECREASED RANGE OF MOTION ABOUT THREE YEARS TWO MONTHS POST IMPLANTATION AND AN ASPIRATION OF THE SYNOVIAL FLUID WAS COMPLETED. THREE DAYS LATER THE PATIENT UNDERWENT AN I&D, WITH POLY EXCHANGE, FOR A PERIPROSTHETIC INFECTION WITHOUT COMPLICATION. AFTER COMPLETING IV AND ORAL ANTIBIOTICS, THE PATIENT BEGAN TO EXPERIENCE PAIN, SWELLING, LIMITED RANGE OF MOTION, AND DIFFICULTY AMBULATING. EIGHT MONTHS AFTER THE I&D, AN ASPIRATION WAS COMPLETED AND THE CULTURE RESULTS INDICATED AN ONGOING INFECTION RELATED TO STAPH EPIDERMITIS. SUBSEQUENTLY, THE PATIENT UNDERWENT THE FIRST STAGE OF A TWO STAGE REVISION WHERE ALL IMPLANTS WERE REMOVED AND A TEMPORARY SPACER WAS IMPLANTED. APPROXIMATELY TWO MONTHS LATER, THE PATIENT UNDERWENT THE SECOND STAGE REVISION WHERE MODERATE OSTEOLYSIS WAS NOTED AROUND THE TIBIAL AND FEMORAL COMPONENTS THAT WAS CONSISTENT WITH THE PREVIOUS INFECTION/EXPLANTATION AND A REVISION KNEE SYSTEM WAS IMPLANTED WITHOUT COMPLICATION.

  Patient problems: Ambulation or Postural Difficulties; Bacterial Infection; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19668378 ↗
• InjurySep 21, 2023Malposition of Device; Malposition of Device

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

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

  MAUDE report 17790277 ↗
• InjurySep 12, 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: Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17730369 ↗
• 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); Cyst(s); Joint effusion; Pain; Scar Tissue

  MAUDE report 17383523 ↗
• InjuryJun 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, SIX (6) YEARS POST-IMPLANTATION, THE PATIENT REPORTED THAT THEY ARE BEING CONSIDERED FOR A REVISION SURGERY DUE TO PAIN AND LOOSENING. THE PATIENT HAS AMBULATION DIFFICULTIES AND MUST PRIMARILY WEAR A KNEE BRACE. A REVISION SURGERY IS NOT CURRENTLY SCHEDULED AND IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17167274 ↗
• 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 16896376 ↗
• InjuryFeb 7, 2023Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THIRTEEN MONTHS POST-IMPLANTATION DUE TO PAIN AND LOOSENING OF THE TIBIAL TRAY. DURING THE REVISION, BONE LOSS WAS NOTED AROUND THE FEMORAL AND THE TIBIAL TRAY AND STEM.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 16311184 ↗
• InjuryDec 14, 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 RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT HAS SUBSEQUENTLY EXPERIENCED PAIN FOR OVER ONE YEAR POST-IMPLANTATION. INFECTION HAS BEEN RULED OUT AND THE MEDICAL TEAM CANNOT DETERMINE WHAT IS CAUSING THE PAIN. THE CURRENT OUTCOME OF THE PATIENT IS UNKNOWN AND FURTHER PLANNED MEDICAL INTERVENTION HAS NOT BEEN REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15975743 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWENTY MONTHS POST-IMPLANTATION DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 15632802 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT CLAIMS TO SUFFER FROM PAIN, ESPECIALLY AT NIGHT, JUST ABOVE THE KNEE ON THE RIGHT SIDE. THE PATIENT STATES IT FEELS LIKE SOMEONE IS STABBING HIM WITH A SHARP KNIFE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 14273032 ↗
• MalfunctionApr 15, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING A RIGHT TOTAL KNEE ARTHROPLASTY, THE POST-OPERATIVE X-RAYS SHOWED MALROTATION OF THE TIBIAL TRAY. NO REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117439 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROSCOPIC DEBRIDEMENT OF SCAR TISSUE DUE TO PAIN AND SWELLING APPROXIMATELY SIX MONTHS POST IMPLANTATION. UPON FOLLOW-UP, THE PATIENT SHOWED IMPROVEMENT IN PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 13366056 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN APPROXIMATELY 3 YEARS POST IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 13087862 ↗
• MalfunctionOct 20, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT AFTER THE TIBIA AND FEMUR WERE CEMENTED, THE SURGEON FELT THAT THERE WAS AN ISSUE WITH THE ANTERIOR PORTION OF THE TIBIA WHERE THE POLY INSERTION INSTRUMENT ENGAGES FOR FINAL POLY INSERTION. THE INSTRUMENT WOULD NOT ENGAGE CORRECTLY AND THE POLY WOULDN'T SEAT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669563 ↗
• InjuryOct 7, 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

  MAUDE report 12589459 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Numbness; Pain; Swelling/ Edema

  MAUDE report 12514511 ↗
• InjurySep 9, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL COMPONENT LOOSENING AND INCREASING PAIN APPROXIMATELY FIVE (5) YEARS POST-OPERATIVELY. INITIAL OPERATIVE NOTES DID NOT NOTE ANY INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED THAT THE MEDIAL TIBIAL PLATEAU OF THE TIBIAL COMPONENT WAS LOOSE. UPON REMOVAL OF THE TIBIAL COMPONENT, THE TIBIA MEDIAL SIDE HAD BONE THAT WAS REPORTEDLY SOFT AND MUSHY. EXTENSIVE SCAR TISSUE WAS FOUND INVOLVING THE PATELLA AND MEDIAL PROXIMAL TISSUE. THE FEMORAL COMPONENT WAS NOTED TO BE WELL-FIXED, HOWEVER, THE TIBIAL COMPONENT COULD NOT BE REMOVED WITHOUT REMOVAL OF THE FEMORAL COMPONENT, SO THE SURGEON REMOVED ALL COMPONENTS EXCEPT THE PATELLA. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Calcium Deposits/Calcification; Inadequate Osseointegration; Osteopenia/ Osteoporosis; Pain; Scar Tissue

  MAUDE report 12449215 ↗
• InjuryAug 9, 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: Extraskeletal ossification; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12293784 ↗
• InjuryMar 23, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11556023 ↗
• InjuryJun 1, 2020Adverse 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 DUE TO STIFFNESS APPROXIMATELY TWO MONTHS AND ONE-WEEK POST IMPLANTATION. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Limited Mobility Of The Implanted Joint; Muscular Rigidity; Scar Tissue

  MAUDE report 10106610 ↗

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-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-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-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-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

…and 25 more.