PERSONA® Natural Tibia® 42-5320-071-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00889024471054), received between Oct 23, 2019 and Aug 28, 2026 — classified as 36 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 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 43 reports, in the reporter's own words as published by the FDA.

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

  It was reported that the patient underwent an initial left total knee arthroplasty. Subsequently, the patient reported lateral knee pain with occasional swelling approximately 2 years post-op. Lucency was noted on CT scan. Physical therapy was prescribed. Attempts have been made and all available information has been provided.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 50495783 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. APPROXIMATELY 3.5 YEARS POSTOP, THE PATIENT WAS REVISED DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 24232988 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3.5 YEARS POST-OP, THE PATIENT WAS EXPERIENCING PAIN WITHOUT RELIEF FROM PHYSIOTHERAPY, A PAIN MANAGEMENT SPECIALIST, AND REHABILITATION. IMAGING REVEALED INCREASED UPTAKE AT THE PATELLA AND MEDIAL TIBIAL AREA. SUBSEQUENTLY, THE PATIENT WAS REVISED. ALL COMPONENTS WERE REVISED. THERE WAS NO LOOSENING SEEN, HOWEVER, THE SURGEON NOTED AREAS OF SOFTER BONE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 24052755 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 23810351 ↗
• InjuryDec 8, 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 23744759 ↗
• InjuryDec 5, 2025Implant subsidence; Implant subsidence

  NO ADDITIONAL INFORMATION

  Patient problems: Insufficient Information

  MAUDE report 23728535 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22973272 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22903286 ↗
• InjuryJun 23, 2025Adverse 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. APPROXIMATELY 3 YEARS POST-OP, THE PATIENT REPORTED EXPERIENCING LEFT KNEE PAIN, SWELLING, STIFFNESS, AND SOME FLUID ACCUMULATION. NO TREATMENT OR INTERVENTION HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 22306629 ↗
• InjuryMar 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL LOOSENING APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21624257 ↗
• InjuryMar 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS ASEPTIC TIBIAL LOOSENING APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21558164 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL BILATERAL KNEE ARTHROPLASTY. THE PATIENT REPORTS CHRONIC ISSUES WITH BOTH KNEES INCLUDING PAN AND SWELLING. THE PATIENT HAD AN MRI WITH FINDINGS OF BONE NECROSIS, QUADRICEPS AND PATELLA TENDINOSIS, PATELLAR TENDON PERFORATION, AND MODERATE EFFUSION. THE DEVICES REMAIN IMPLANTED AT THIS TIME.

  Patient problems: Inflammation; Muscle/Tendon Damage; Necrosis; Pain

  MAUDE report 21245610 ↗
• InjuryDec 30, 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: Cellulitis; Skin Discoloration; Swelling/ Edema; Unspecified Infection

  MAUDE report 21034994 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED PES BURSITIS ACCOMPANIED BY PAIN AND SWELLING APPROXIMATELY THREE (3) MONTHS FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT RECEIVED A STEROID INJECTION AS TREATMENT. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bursitis; Pain; Swelling/ Edema

  MAUDE report 20688198 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED PAIN AND SWELLING WITH SLIGHT WARMNESS IN THEIR CALF ON APPROXIMATELY 8 DAYS POST-OP. A DOPPLER WAS PERFORMED THAT CONFIRMED THE PATIENT WAS POSITIVE FOR A LOWER LEG DVT IN THE POSTERIOR TIBIAL VEIN AND HEMATOMA IN THE CALF. THE PATIENT WAS PRESCRIBED BABY ASPIRIN. THE PATIENT THEN PRESENTED TO THE ER AND WAS PRESCRIBED AN ELIQUIS STARTER PACK FOR THE DISTAL DVT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hematoma; Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 20664812 ↗
• InjuryOct 8, 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 20395456 ↗
• InjurySep 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 20295437 ↗
• MalfunctionSep 16, 2024Off-Label Use; Off-Label Use

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226342 ↗
• MalfunctionJul 2, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING AN INITIAL KNEE PROCEDURE, AFTER TRIALING AND SIZING, WHEN THE SURGEON WENT TO IMPLANT THE FINAL TIBIAL TRAY, IT DID NOT MATCH THE EXPECTED SIZING. A LARGER TIBIAL TRAY OPENED AND IMPLANTED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656261 ↗
• InjuryMay 8, 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 TEN MONTHS POST IMPLANTATION DUE TO TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19269265 ↗
• MalfunctionApr 10, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT HAIR WAS FOUND IN STERILE COMPONENT PACKAGE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078437 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND LIMITED RANGE OF MOTION AND UNDERWENT A SYNOVECTOMY IN AN UNKNOWN TIMEFRAME POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 17900439 ↗
• InjuryJul 19, 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: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 17350379 ↗
• InjuryJul 12, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY TO ADDRESS PAIN AND MILD TIBIAL IMPLANT LOOSENING. DURING THE REVISION, HOWEVER, THE IMPLANTS WERE NOTED TO BE WELL-FIXED, AND THE SURGEON STRUGGLED TO REMOVE THEM. ALL COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17312515 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH BILATERAL LOWER LOBE PNEUMONIA THROUGH CHEST X-RAY. THE PATIENT WAS PLACED ON AUGMENTIN FOR 7 DAYS. THE PNEUMONIA RESOLVED 3 WEEKS LATER WITHOUT FURTHER COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pneumonia

  MAUDE report 15990533 ↗

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-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-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-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-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.