PERSONA® Natural Tibia® 42-5320-079-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00889024471092), received between Feb 13, 2020 and Aug 10, 2026 — classified as 22 injuries, 5 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent an initial left knee surgery. Subsequently, the patient was revised due to femoral and tibial loosening approximately 4 years post-op. All available information has been provided.

  Patient problems: Aseptic loosening

  MAUDE report 50191690 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Fluid Discharge

  MAUDE report 25163394 ↗
• MalfunctionSep 10, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017896 ↗
• InjuryMay 2, 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: Loss of Range of Motion; Pain

  MAUDE report 21951943 ↗
• InjuryNov 20, 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; Loss of Range of Motion; Pain

  MAUDE report 20735478 ↗
• InjuryMay 7, 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 AN I&D WITH POLY EXCHANGE ONE MONTH POST PROCEDURE. SUBSEQUENTLY, WITHIN A ONE MONTH POST-OPERATIVE TIMEFRAME, THE PATIENT DEVELOPED A DEEP VEIN THROMBUS AND WAS PLACED ON ELIQUIS. DUE TO A REACTION TO ELIQUIS, AN IVC FILTER WAS THEN PLACED AND THE PATIENT WAS REFERRED TO A HEMATOLOGIST FOR CONCERN FOR A BLOOD CLOTTING DISORDER

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19260920 ↗
• InjuryApr 22, 2024Naturally Worn; Naturally Worn

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

  Patient problems: Joint effusion; Pain; Synovitis

  MAUDE report 19159457 ↗
• MalfunctionApr 3, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE DEVICE WOULD NOT ASSEMBLE IN MATING IMPLANT. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031414 ↗
• InjuryMar 12, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

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

  Patient problems: Adhesion(s); Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18890605 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ACUTE INFECTION TKP LET WITH HEMOLYTIC STREPTOCOCCUS GROUP G, THAT LED TO HOSPITALIZATION OF PATIENT WITH IV ANTIBIOTIC TREATMENT (AMOXICILLINE IV AND CLINDAMYCIN). THE COMPLICATION WAS RESOLVED 4 MONTHS AFTER DATE OF OCCURRENCE, KNEE IS NOW DOING WELL, NO SYMPTOMS, NO SICKNESS, NO SIGNS OF INFECTION, AND TREATMENT HAS THEREFORE BEEN CONCLUDED.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18440117 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA TWO MONTHS POST IMPLANTATION DUE TO ARTHROFIBROSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 17171092 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A KNEE REPLACEMENT SURGERY. SUBSEQUENTLY, 2 YEARS POST PROCEDURE THE PATIENT IS STILL SUFFERING FROM PAIN WHILE PERFORMING DAILY ACTIVITIES. PATIENT CLAIMS HE HAS BEEN FACING PAIN SINCE DAY OF THE SURGERY AND CURRENTLY CAN FEEL THE PAIN NEAR THE BONE OVERHANG AREA. POSSIBLE FUTURE REVISION.

  Patient problems: Pain

  MAUDE report 16886064 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS STIFFNESS, SWELLING, DISCOMFORT AND RECURRENT EFFUSIONS APPROXIMATELY FIVE YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Joint effusion; Swelling/ Edema

  MAUDE report 16763133 ↗
• InjuryApr 4, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. APPROXIMATELY 7 MONTHS LATER, THE PATIENT FELL AND AN IMPLANT CAME LOOSE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Fall

  MAUDE report 16676143 ↗
• MalfunctionFeb 28, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND INSTABILITY SINCE THE SURGERY. NO MEDICAL INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 16453002 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO A FALL. PAIN AND JOINT LAXITY WAS NOTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 16225729 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEVELOPED DEEP VEIN THROMBOSIS AND WAS TREATED MEDICALLY 26 DAYS POST IMPLANTATION. THE COMPONENTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16215863 ↗
• MalfunctionJul 15, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE IMPLANT WAS OPENED WITH ANOTHER CONTAMINATED IMPLANT. SURGEON ELECTED NOT TO USE EITHER IMPLANT DUE TO ONE BEING CONTAMINATED. BOTH IMPLANTS WERE CONSIDERED CONTAMINATED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15027141 ↗
• MalfunctionFeb 16, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE SURGEON STATED THE IMPLANT BOX LOOKED DAMAGED AND STERILITY COMPROMISED. 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 13546767 ↗
• InjuryNov 17, 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: Wound Dehiscence

  MAUDE report 12830604 ↗
• InjuryMay 17, 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: Erosion; Failure of Implant; Loss of Range of Motion; Pain; Scar Tissue; Skin Burning Sensation

  MAUDE report 11831307 ↗
• InjuryMar 29, 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: Adhesion(s); Cyst(s); Erosion; Failure of Implant; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 11582750 ↗
• InjuryAug 17, 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: Pain; Swelling

  MAUDE report 10413129 ↗
• InjuryJun 8, 2020Loss of or Failure to Bond; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Limited Mobility Of The Implanted Joint; Loss of Range of Motion

  MAUDE report 10127754 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT KNEE REVISION APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO INSTABILITY, PAIN, AND DIFFICULTY WALKING AND STANDING. THE ARTICULAR SURFACE WAS REMOVED AND REPLACED. SUBSEQUENTLY, THE PATIENT CONTINUES TO EXPERIENCE THE SAME SYMPTOMS AFTER THE REVISION SURGERY. IT WAS ALSO NOTED THAT THE KNEE IS DISCOLORED (DARK, BLACK) SINCE THE PROCEDURE.

  Patient problems: Bruise/Contusion; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 9899251 ↗

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-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-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-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.