PERSONA® Natural Tibia® 42-5320-067-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00889024471047), received between Mar 24, 2020 and Dec 9, 2025 — classified as 44 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (15 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 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: Joint Laxity

  MAUDE report 23756995 ↗
• InjurySep 3, 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: Erythema

  MAUDE report 22957332 ↗
• InjurySep 3, 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: Erythema

  MAUDE report 22957300 ↗
• InjurySep 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: Hypoxia; Pulmonary Embolism; Tachycardia

  MAUDE report 22936277 ↗
• InjuryJul 14, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REVISION SURGERY ONE YEAR, SIX MONTHS POST IMPLANTATION DUE TO TIBIAL LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22495983 ↗
• InjuryMar 20, 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 PAIN AND PROGRESSION OF TIBIAL LUCENCY APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. DURING THE REVISION, ALL COMPONENTS WERE FOUND TO BE WELL-FIXED. ALL COMPONENTS EXCEPT THE PATELLA WERE REVISED FOR A TWO-STAGE REVISION DUE TO SUSPECTED INFECTION, ALTHOUGH INFECTION WAS RULED OUT POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Radiolucent Lines

  MAUDE report 21652168 ↗
• InjuryFeb 24, 2025Adverse 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. APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY. ALL COMPONENTS WERE REVISED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 21448686 ↗
• InjuryDec 4, 2024Loss 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 ONE YEAR AND EIGHT MONTHS POST IMPLANTATION DUE TO TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20846599 ↗
• InjuryOct 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY THREE (3) YEARS POST-IMPLANTATION DUE TO IMPLANT LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20520980 ↗
• MalfunctionOct 2, 2024Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353681 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. A FEW DAYS FOLLOWING THE SURGERY, WHILE THE PATIENT WAS STILL IN THE HOSPITAL, THEY MIS-STEPPED AND TORE MULTIPLE LIGAMENTS. PATIENT WAS REVISED A WEEK POST-IMPLANTATION DUE TO LIGAMENT AND SOFT TISSUE DAMAGE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 19323094 ↗
• InjuryApr 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REVISION PROCEDURE 9 MONTHS POST IMPLANTATION DUE TO PAIN AND TIBIAL LOOSENING.

  Patient problems: Pain

  MAUDE report 19163745 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE MONTH POST IMPLANTATION, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS AND STIFFNESS AND CONTINUED TO EXPERIENCE SLIGHT RANGE OF MOTION ISSUES AND DISCOMFORT. APPROXIMATELY 22 MONTHS LATER, THE STUDY WAS COMPLETE WITHOUT FURTHER COMPLICATIONS AND ALL IMPLANTS REMAINED IN PLACE.

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

  MAUDE report 19070173 ↗
• InjuryApr 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19031415 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS EXPERIENCED ONGOING PAIN, SWELLING, AND HEAT IN THE JOINT. ALLERGY TESTING INDICATED REACTIVITY TO CERTAIN ELEMENTS CONTAINED IN THE IMPLANTS. THE PATIENT REQUESTED MATERIAL ANALYSIS FOR THIS CORRELATION AND HAS NOT EXPRESSED AN INTENT TO PURSUE FURTHER MEDICAL OR SURGICAL INTERVENTION AT THIS TIME.

  Patient problems: Alteration in Body Temperature; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 18979180 ↗
• InjuryDec 21, 2023Adverse 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: Muscle/Tendon Damage

  MAUDE report 18375310 ↗
• InjuryDec 12, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 18310105 ↗
• InjuryJul 25, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVENTEEN MONTHS POST IMPLANTATION DUE TO PAIN, DECREASED DAILY ACTIVITIES, AND AMBULATION DIFFICULTIES. DURING THE REVISION IT WAS NOTED, PATIENT HAD SYNOVITIS, LOOSE TIBIA AND CEMENT FRAGMENTS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

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

  MAUDE report 17388210 ↗
• InjuryJun 15, 2023Migration; Migration

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

  Patient problems: Cellulitis; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 17133994 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO LIMITED RANGE OF MOTION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16859987 ↗
• InjuryMar 29, 2023Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 3.5 YEARS LATER, THE PATIENT UNDERWENT THE FIRST STAGE OF A REVISION DUE TO IMPLANT FAILURE. BOTH FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AFTER NOTED BONE LOSS. NO INFECTION WAS FOUND IN THE PATIENT AT THIS POINT, HOWEVER, INTRAOP SAMPLES HAVE BEEN SENT TO BE EVALUATED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16635661 ↗
• InjuryJan 18, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL PROSTHESIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16194760 ↗
• MalfunctionDec 14, 2022Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978639 ↗
• InjuryDec 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT RIGHT TKA PROCEDURE. SUBSEQUENTLY THE PATIENT WAS REVISED FOR FEMORAL AND TIBIAL LOOSENING APPROXIMATELY 2 YEARS POST IMPLANTATION.

  Patient problems: Joint Laxity

  MAUDE report 15904071 ↗
• InjuryOct 26, 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 APPROXIMATELY ONE YEAR FIVE AND A HALF MONTHS POST IMPLANTATION DUE TO TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 15672394 ↗

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-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-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-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-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

…and 25 more.