PERSONA® Natural Tibia® 42-5320-075-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00889024471078), received between Mar 13, 2020 and Jul 31, 2026 — classified as 33 injuries, 1 malfunction.

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 34 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Migration

  It was reported that the patient underwent a knee arthroplasty revision to address tibial tray migration resulting in instability. Upon removal of the components, femoral osteolysis around the metaphyseal region of the femur was identified that extended to the posterior condyles both medially and laterally. All components were revised and replaced. Attempts have been made, however, no additional information is available.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 50100361 ↗
• InjuryNov 13, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING SWELLING AND POSSIBLE ALLERGIC REACTION APPROXIMATELY TWO YEARS SEVEN MONTHS POST IMPLANTATION. THE PATIENT CALLED STATING HE NEEDS TO KNOW IF HIS IMPLANT CONTAINS NICKEL AS HE HAS BEEN FOUND TO BE ALLERGIC TO NICKEL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 23544405 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED A PATIENT HAD AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT BEGAN EXPERIENCING PAIN, ONGOING SWELLING, JOINT EFFUSIONS, PERSISTENT CLICKING, AND GIVING AWAY. RADIOGRAPHIC IMAGING, SERUM INFECTION MARKERS, AND AN ASPIRATION WERE PERFORMED 8 MONTHS POST IMPLANTATION, AND THE TESTING RENDERED NO SIGNIFICANT FINDINGS. JOINT LAXITY MEDIALLY AND LATERALLY FOUND UPON ASSESSMENT. SUBSEQUENTLY, ONE YEAR POST-IMPLANTATION, THE PATIENT UNDERWENT A REVISION PROCEDURE. THE ARTICULAR SURFACE WAS EXCHANGED FOR A LARGER SIZE WITHOUT COMPLICATION AND THE PATIENT'S STABILITY ISSUES DURING RANGE OF MOTION HAVE BEEN REPORTED AS RESOLVED. THE FEMORAL AND TIBIAL COMPONENTS REMAIN IMPLANTED.

  Patient problems: Joint Laxity; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 22669005 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS REVISED ONE YEAR, NINE MONTHS POST PROCEDURE DUE TO PAIN AND STIFFNESS (ASEPTIC). FEMORAL, TIBIAL AND BEARING WERE REVISED. THE PATELLA WAS NOT REVISED.

  Patient problems: Pain

  MAUDE report 21277400 ↗
• InjuryNov 12, 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 LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, 7 DAYS POST IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE CHEST TIGHTNESS. THE PATIENT WAS ULTIMATELY DIAGNOSED WITH MYOCARDIAL INFARCTION REQUIRING PLACEMENT OF 2 STENTS APPROXIMATELY 15 DAYS POST IMPLANTATION. THE EVENT HAS NOW BEEN DOCUMENTED WITHIN THE STUDY AS RESOLVED, NO DEVICE DEFICIENCIES OR ABNORMALITIES HAVE BEEN REPORTED AT THE 3-MONTH FOLLOW-UP AND ALL INITIAL COMPONENTS REMAIN IMPLANTED.

  Patient problems: Myocardial Infarction

  MAUDE report 20664588 ↗
• InjuryOct 29, 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: Loss of Range of Motion

  MAUDE report 20560397 ↗
• InjuryOct 24, 2024Adverse 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 10 MONTHS POST IMPLANTATION DUE TO PAIN, SWELLING, AND INSTABILITY. DURING THE REVISION, SCAR TISSUE WAS DEBRIDED AND A MANIPULATION UNDER ANESTHESIA WAS PERFORMED, AND THE COMPONENTS WERE NOTED TO BE WELL FIXED. ALL IMPLANTS WERE REPLACED WITHOUT COMPLICATIONS.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20521526 ↗
• InjuryOct 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO (2) YEARS AND SIX (6) WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE TIBIAL COMPONENT. THE LOOSENED DEVICE WAS REPLACED WITHOUT COMPLICATION. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 20517384 ↗
• InjuryJul 17, 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

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

  Patient problems: Failure of Implant

  MAUDE report 19761745 ↗
• InjuryJun 21, 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; Joint Laxity

  MAUDE report 19583494 ↗
• InjuryJun 21, 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: Synovitis

  MAUDE report 19583166 ↗
• InjuryJun 12, 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; Pain

  MAUDE report 19518848 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR THREE WEEKS POST IMPLANTATION DUE TO PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19208490 ↗
• InjuryApr 3, 2024Fracture; Fracture

  IT WAS REPORTED, THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION. APPROXIMATELY 5.5 YEARS POST IMPLANTATION, DUE TO A FRACTURED TIBIAL PLATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information; Metal Related Pathology; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19038176 ↗
• InjuryMar 11, 2024Mechanical Jam; Migration; Mechanical Jam; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS PAIN, SWELLING AND INSTABILITY THAT WAS INTERFERING WITH RANGE OF MOTION APPROXIMATELY ONE YEAR POST-OPERATIVELY. THE SURGEON REPORTED THAT THE TIBIAL ROTATION DID NOT MATCH THE CORRECT PLACEMENT FOR A MEDIAL CONGRUENT BEARING AS THE SOFT TISSUES WERE TOO TIGHT TO ALLOW COMPONENT ARTICULATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

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

  MAUDE report 18882008 ↗
• InjuryJan 16, 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: Unspecified Infection

  MAUDE report 18519980 ↗
• InjuryDec 18, 2023Use of Device Problem; Manufacturing, Packaging or Shipping Problem; Use of Device Problem; Manufacturing, Packaging or Shipping Problem

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344396 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, AS THE SURGEON PLACED THE TIBIAL INSERT INTO THE TIBIAL TRAY USING AN INSERTER, THE TIBIAL TRAY CRACKED AND SMALL CHIP BROKE FROM THE TRAY. THE TIBIAL TRAY AND INSERT WERE REMOVED AND ADDITIONAL IMPLANTS WERE 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 18124248 ↗
• InjurySep 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THE PATIENT A LEFT KNEE REVISION APPROXIMATELY TWO AND A HALF YEARS POST-IMPLANTATION DUE TO PAIN AND TIBIAL SUBSIDENCE. DURING REMOVAL OF THE TIBIAL TRAY, IT WAS NOTED THAT THE CEMENT REMAINED ATTACHED TO THE MEDIAL SIDE OF THE TIBIA (WHICH HAD SUBSIDED) AND CAME DETACHED FROM THE LATERAL SIDE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; Pain; Scar Tissue

  MAUDE report 17741195 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN IN KNEE AND UNABLE TO STAND OR WALK FOR JUST A FEW MINUTES THREE YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17469711 ↗
• InjuryJun 28, 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 17216235 ↗
• InjuryJun 13, 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; Unspecified Infection

  MAUDE report 17119272 ↗
• InjuryJan 10, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY NINE MONTHS POST-IMPLANTATION DUE TO STIFFNESS AND TIBIAL LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 16133906 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. LEGAL COUNSEL IS REPORTING PATIENT HAS FILED AN UNKNOWN ALLEGATION. PATIENT HAS NOT BEEN REVISED TO DATE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15950471 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED IN A CLINICAL STUDY THAT THE PATIENT UNDERWENT A LEFT KNEE PROCEDURE. SUBSEQUENTLY, 2 YEARS 6 MONTHS POST PROCEDURE, THE PATIENT HAS PAIN IN THE LEFT KNEE. ATTEMPTS TO GATHER ADDITIONAL INFORMATION ARE UNDERWAY. HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 14944992 ↗

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-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
• 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.