PERSONA® Natural Tibia® 42-5320-067-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00889024471030), received between Nov 20, 2019 and Sep 28, 2026 — classified as 35 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 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 39 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an initial left knee surgery. Subsequently, the patient fell, fractured their fibula, and blew out their MCL and was revised approximately 4 years post-op. Attempts have been made and all available information has been provided.

  Patient problems: Bone Fracture(s); Damage to Ligament(s)

  MAUDE report 50919292 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a revision approximately 2 years and 8 months post-implantation due to flexion instability. It was reported that no further information is available.

  Patient problems: Joint Laxity

  MAUDE report 50133120 ↗
• InjuryAug 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent an initial knee surgery. Subsequently, the patient was revised due to both femoral and tibial loosening approximately 2 years post-op. The bone-cement interface was intact on both the tibia and femur, however, the implant-cement interface was where the loosening occurred. All available information has been provided.

  Patient problems: Aseptic loosening

  MAUDE report 50114051 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  A MANUSCRIPT WAS OBTAINED ON 06-JAN-2026 THAT REPORTED A RANDOMIZED CONTROLLED TRIAL STUDY FROM THE NETHERLANDS CONDUCTED FROM 05-DEC-2022 AND 03-JUL-2024 AT THE ZUYDERLAND MEDICAL CENTER. THE PURPOSE OF THE STUDY WAS TO COMPARE ROBOTIC-ASSISTED INVERSE KINEMATIC ALIGNMENT TOTAL KNEE ARTHROPLASTY WITH MECHANICALLY ALIGNED TOTAL KNEE ARTHROPLASTY. A TOTAL OF 150 PATIENTS WERE INCLUDED AND UNDERWENT RANDOMIZATION; 73 PATIENTS WERE ASSIGNED TO THE ROSA ROBOTIC-ASSISTED TKA GROUP AND 77 PATIENTS TO THE CONVENTIONAL MA TKA GROUP. IN THE ROBOTIC-ASSISTED TKA GROUP, 7 PATIENTS WERE CONVERTED TO CONVENTIONAL TKA. A STANDARD MEDIAL PARAPATELLAR APPROACH WAS USED IN ALL PATIENTS; PATELLAR RESURFACING WAS DONE ONLY IN SELECTED CASES AND A FULLY CEMENTED, CRUCIATE RETAINING KNEE PROSTHESIS WAS IMPLANTED. ZIMMER BIOMET PERSONA WAS USED IN ALL CASES EXCEPT VANGUARD IN 2 CASES. THE STUDY POPULATION HAD A MEAN AGE OF 69.7 YEARS AT TIME OF SURGERY; (51 MALES / 77 FEMALES). FOLLOW-UP CONSISTED OF FUNCTIONAL AND SATISFACTION SCORING WITHIN 12 MONTHS WITH A MINIMUM FOLLOW UP OF 12 MONTHS. THE ARTICLE REPORTED ONE (1) PATIENT IN THE CONVENTIONAL GROUP EXPERIENCED POSTOPERATIVE PAIN ON AN UNKNOWN TIMEFR

  Patient problems: Pain

  MAUDE report 25166955 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS IN A JOURNAL ARTICLE THAT PATIENT REQUIRED WOUND EXCISION APPROXIMATELY 4 MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Impaired Healing

  MAUDE report 25162510 ↗
• InjuryMay 4, 2026Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL TKA. SUBSEQUENTLY, ABOUT 4 YEARS LATER THEY HAD A REVISION SURGERY DUE TO TIBIAL SUBSIDENCE AND LOOSENING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 25069472 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 6 MONTHS BEFORE, THE PATIENT REPORTED EXPERIENCING A POPPING SENSATION. ON EVALUATION, THE PATIENT DEMONSTRATED GOOD STABILITY, BALANCE, AND APPROPRIATE PATELLAR TRACKING. THE PATIENT WAS DIAGNOSED WITH PATELLAR TENDINITIS, PES ANSERINE BURSITIS, AND ILIOTIBIAL BAND INSERTIONAL TENDERNESS. TREATMENT INCLUDED A LEFT BURSA INJECTION AND A LEFT ILIOTIBIAL BAND INJECTION. THE PATIENT WAS ALSO INSTRUCTED TO APPLY A TOPICAL ANTI-INFLAMMATORY CREAM AND WAS PROVIDED WITH A COMPRESSION STOCKING. THERE WERE NO CONCERNS OR ALLEGATIONS REGARDING THE IMPLANTED COMPONENTS, WHICH REMAIN IN PLACE. THE EVENT HAS BEEN REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Discomfort; Tendinopathy

  MAUDE report 24955050 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 23942933 ↗
• InjuryDec 30, 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: Aseptic loosening

  MAUDE report 23924256 ↗
• MalfunctionNov 5, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476341 ↗
• InjurySep 15, 2025Biocompatibility; Biocompatibility

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

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

  MAUDE report 23057561 ↗
• InjuryMay 29, 2025Malposition of Device; Unintended Movement; Malposition of Device; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE INSTABILITY. SUBSEQUENTLY, THE PATIENT UNDERWENT A SYNOVECTOMY AND REVISION SURGERY WHERE MALROTATION OF THE TIBIAL COMPONENT WAS FOUND. THE TIBIAL TRAY, TIBIAL STEM EXTENSION AND ARTICULAR SURFACE WERE EXCHANGED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Failure of Implant; Joint Laxity; Synovitis

  MAUDE report 22106040 ↗
• InjuryMar 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE THREE YEARS POST IMPLANTATION DUE TO TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Aseptic loosening; Failure of Implant; Joint Laxity; Pain

  MAUDE report 21691256 ↗
• InjuryFeb 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT BEGAN EXPERIENCING RESTRICTED RANGE OF MOTION, PERSISTENT PAIN, WALKING DIFFICULTIES, SWELLING, AND DIFFICULTY PERFORMING DAILY ACTIVITIES SEVEN MONTHS POST IMPLANTATION. BETWEEN RADIOGRAPHIC IMAGING AND ASSESSMENT, PATELLAR BAJA, ABNORMAL PATELLAR TRACKING, AND ABNORMAL PATELLAR HEIGHT WAS FOUND. THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY AND WAS REFERRED TO NEUROSURGERY FOR A POTENTIAL GENICULATE BLOCK. SYMPTOMS WERE ONGOING WITH AN INCREASING FEEING OF LOCKING AND INSTABILITY IN THE KNEE. X-RAYS SHOWED TIBIAL AND FEMORAL RADIOLUCENCY, AND A BONE SCAN SHOWED REUPTAKE THROUGHOUT THE KNEE. THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED ONE YEAR, ONE MONTH LATER DUE TO LOOSENING. PATELLAR IMPLANT REMAINED. ARTICULAR SURFACE REPLACED AS A BEST PRACTICE. THE STUDY SITE HAS MINIMAL INFORMATION AS THE REVISION OCCURRED AT AN OUTSIDE FACILITY.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Loss of Range of Motion; Pain; Radiolucent Lines; Swelling/ Edema; Synovitis

  MAUDE report 21357471 ↗
• InjuryOct 29, 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 20560233 ↗
• InjuryOct 11, 2023Loosening 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 17912733 ↗
• MalfunctionJun 28, 2023Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215663 ↗
• InjuryJun 22, 2023Migration; Migration

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO TIBIAL WAS SUBSIDING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 17187114 ↗
• InjuryMay 19, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TWENTY (20) DAYS POST-OPERATIVELY TO ADDRESS A PERIPROSTHETIC FRACTURE WITH AN UNSTABLE DISPLACED TIBIAL IMPLANT AFTER A FALL. DURING THE PROCEDURE, SOFT TIBIAL BONE AND A MEDIAL RETINACULUM TEAR WITH AN INTACT PATELLA TENDON ATTACHED TO THE TUBEROSITY FRACTURE WERE ALSO IDENTIFIED. A MESH PLATE WAS USED TO REDUCE THE FRACTURE AND THE TIBIAL COMPONENTS WERE REPLACED AND A STEM EXTENSION AND LARGE CENTRAL CONE WERE ADDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Bone Fracture(s); Failure of Implant; Fall; Muscle/Tendon Damage; Osteopenia/ Osteoporosis

  MAUDE report 16966578 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS SHIFTING OF THE ARTICULAR SURFACE AND A TIBIAL STRESS FRACTURE A FEW HOURS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16894938 ↗
• InjuryApr 12, 2023Unintended Movement; Unintended Movement

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

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

  MAUDE report 16726340 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT HAD A MANIPULATION UNDER ANESTHESIA ON AN UNKNOWN DATE DUE TO ARTHROFIBROSIS, STIFFNESS, PAIN, AND DECREASED ROM. PATIENT NOW REPORTS SWELLING SINCE ARTHROSCOPY. SUBSEQUENTLY 1ST STAGE REVISION DUE TO SUSPECTED INFECTION. DURING THE PROCEDURE NOTED SCAR TISSUE AND EROSIVE CHANGES TO THE MEDIAL TIBIA. ALL COMPONENTS AND CEMENT REMOVED. NAIL AND ANTIBIOTIC CEMENT IMPLANTED WITHOUT COMPLICATIONS.

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

  MAUDE report 16521277 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT HAD A MANIPULATION UNDER ANESTHESIA ON AN UNKNOWN DATE DUE TO ARTHROFIBROSIS, STIFFNESS, PAIN, AND DECREASED ROM. THICK ABUNDANT SCAR TISSUE WAS EXCISED THROUGHOUT THE JOINT. UNFORTUNATELY SYMPTOMS CONTINUED WITH ADDITION OF SWELLING. KNEE ASPIRATION X 2 WITH NO GROWTH REPORTED AND NEGATIVE FOR INFECTION.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 16521073 ↗
• InjuryDec 7, 2022Loss 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 DUE TO LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 15931558 ↗
• InjurySep 15, 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Fall; Pain

  MAUDE report 15426531 ↗

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-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-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-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-2579-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6
• 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

…and 25 more.