PERSONA® Natural Tibia® 42-5320-075-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00889024471085), received between Oct 16, 2019 and Mar 5, 2026 — classified as 37 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (13 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE TIBIAL COMPONENT LOOSENED FOLLOWING A PATIENT FALL. SUBSEQUENTLY, THE PATIENT UNDERWENT A KNEE REVISION IN WHICH THE TIBIAL COMPONENT WAS EXPLANTED APPROXIMATELY 10 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 24519408 ↗
• InjuryJan 6, 2026Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening

  MAUDE report 23980312 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, 12 DAYS POST IMPLANTATION THE PATIENT PRESENTED WITH SEROUS DRAINAGE FROM THE DISTAL INCISION AND WAS PRESCRIBED AUGMENTIN. THE INCISION WAS HEALED AT THE NEXT FOLLOW-UP A MONTH LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fluid Discharge

  MAUDE report 23851087 ↗
• InjuryDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Insufficient Information

  MAUDE report 23804272 ↗
• InjuryJun 18, 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

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOUR YEARS TWO AND A HALF MONTHS POST IMPLANTATION DUE TO ASEPTIC LOOSENING. DURING THE REVISION THE PATELLA WAS FOUND TO BE GROSSLY LOOSE, THE FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO BE SLIGHTLY MOBILE AND ASEPTIC LOOSENING WAS CONFIRMED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema; Tendinopathy

  MAUDE report 22286291 ↗
• InjuryMay 21, 2025Loosening 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. APPROXIMATELY THREE (3) YEARS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN AND INSTABILITY AND UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. ALL COMPONENTS WERE REVISED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Aseptic loosening; Joint Laxity; Pain

  MAUDE report 22064833 ↗
• InjuryMay 21, 2025Adverse 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 DUE TO INFECTION APPROXIMATELY TWO (2) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22063091 ↗
• InjuryMar 17, 2025Adverse 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: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 21620685 ↗
• InjuryMar 14, 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: Pain

  MAUDE report 21605932 ↗
• InjuryFeb 25, 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 SIX AND A HALF YEARS POST IMPLANTATION DUE TO LOOSENING AND POSSIBLE INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information; Unspecified Infection

  MAUDE report 21457584 ↗
• InjuryFeb 18, 2025Loosening 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; Numbness; Pain; Swelling/ Edema

  MAUDE report 21403116 ↗
• InjuryDec 19, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information; Pain

  MAUDE report 20976865 ↗
• InjuryDec 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: Damage to Ligament(s); Joint Impingement; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20883361 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO PAIN AND INSTABILITY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20516880 ↗
• InjuryJun 4, 2024Noise, Audible; Noise, Audible

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19459322 ↗
• MalfunctionMay 14, 2024Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE BEARING WOULD NOT LOCK INTO THE TIBIA. THERE WAS A VISIBLE GAP AT THE ANTERIOR PORTION OF THE TIBIA BASE PLATE. A SECOND BEARING WAS USED WITH THE SAME RESULTS. THE SECOND BEARING COULD NOT BE REMOVED FROM THE TIBIA BASE PLATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309989 ↗
• InjuryMay 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ONE YEAR POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19221688 ↗
• InjuryApr 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TEN MONTHS POST IMPLANTATION DUE TO PAIN, SWELLING, PERIPROSTHETIC FRACTURE, IMPLANT LOOSENING, AND INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Joint Contracture; Osteolysis; Osteopenia/ Osteoporosis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19166664 ↗
• InjuryMar 29, 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 KNEE SURGERY AND APPROXIMATELY 11 MONTHS LATER, THE PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. THE TIBIAL COMPONENT AND POLY WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fibrosis

  MAUDE report 19003342 ↗
• InjuryMar 19, 2024Loosening 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 PAIN, ARTHROFIBROSIS, STIFFNESS, LIMITED RANGE OF MOTION, RADIOLUCENCY AND TIBIAL AND FEMORAL IMPLANT LOOSENING APPROXIMATELY FIVE (5) YEARS FOLLOWING RIGHT KNEE ARTHROPLASTY. IN THE MONTHS AND YEARS FOLLOWING THE REVISION, THE PATIENT CONTINUED TO PROGRESS AND PAIN RESOLVED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED UNDER THE INDICATION FOR THE PROCEDURE, "THE PATIENT DID HAVE SEVERE ARTHROFIBROSIS WITH AN ARC OF MOTION OF ABOUT 40 DEGREES AS WELL AS RADIOGRAPHIC EVIDENCE OF LOOSENING OF BOTH [THE] FEMORAL AND TIBIAL COMPONENTS." DURING THE PROCEDURE, NOTES NOTED, "THERE WAS SEVERE ARTHROFIBROSIS THROUGHOUT THE ANTERIOR COMPARTMENT AS WELL AS MEDIAL AND LATERAL GUTTERS...NO BONE LOSS DURING REMOVAL OF [THE FEMORAL COMPONENT]...IT DID TAKE QUITE A BIT OF TIME TO EXPOSE THE TIBIAL COMPONENT SECONDARY TO [THE] SEVERE ARTHROFIBROSIS...THERE WERE NO FRACTURES ENCOUNTERED AND ABSOLUTELY NO BONE LOSS WAS ENCOUNTERED DURING TIBIAL COMPONENT REMOVAL." ALL COMPONENTS WERE REMOVED AND NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

  Patient problems: Pain; Radiolucent Lines

  MAUDE report 18932281 ↗
• InjuryFeb 23, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768628 ↗
• MalfunctionDec 27, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE PROCEDURE. DURING THE PROCEDURE, THE TIBIAL INSERT DID NOT SEAT ON THE TIBIAL TRAY. A SECOND TIBIAL INSERT ALSO DID NOT SEEM TO SEAT COMPLETELY, BUT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400793 ↗
• InjuryJul 11, 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: Damage to Ligament(s)

  MAUDE report 17301288 ↗
• InjuryJun 13, 2023Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THREE AND A HALF YEARS POST-IMPLANTATION DUE TO MISALIGNMENT OF THE TIBIAL PLATE AND OVERSTUFFING OF THE PATELLA, LEADING TO A LIMITED RANGE OF MOTION.

  Patient problems: Failure of Implant

  MAUDE report 17119199 ↗
• InjuryApr 5, 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: Pain

  MAUDE report 16685583 ↗

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-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-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-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-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-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
• 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.