Persona® Natural Tibia® Trabecular Metal® 42-5300-083-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024510616), received between Apr 21, 2021 and Mar 20, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K121771, K173417); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 MONTHS POST-IMPLANTATION DUE TO TIBIAL COMPONENT LOOSENING AND PAIN. POSTOPERATIVELY, THE PATIENT DEVELOPED KNEE PAIN, AND AT FOLLOW-UP VISITS THE SURGEON IDENTIFIED PROGRESSIVE TIBIAL COMPONENT LOOSENING ON RADIOGRAPHS WITH MINIMAL TO NO BONE INGROWTH AT THE BONE¿IMPLANT INTERFACE. INTRA-OPERATIVELY DURING THE REVISION, THE TIBIAL COMPONENT WAS CONFIRMED TO BE LOOSE WITH MINIMAL BONE INGROWTH, WAS REMOVED, AND REPLACED WITH A CEMENTED TIBIAL COMPONENT WITH A STEM AND A POLYETHYLENE INSERT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24647529 ↗
• InjuryAug 14, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL COMPONENT LOOSENING AND INFECTION APPROXIMATELY SEVEN (7) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Unspecified Infection

  MAUDE report 22806302 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY AND ONE DAY POST-OP EXPERIENCED A SIGNIFICANT AMOUNT OF DRAINAGE. TWO ADDITIONAL SUTURES WERE PLACED TO THE DISTAL PORTION OF THE INCISION. EIGHT DAYS LATER, THE PATIENT WAS SEEN IN THE OFFICE FOR A FOLLOW-UP APPOINTMENT AND THE DOCTOR NOTES HE COULD SEE WHERE HE HAD SOME BLOODY DRAINAGE AT THE DISTAL PORTION OF THE INCISION. DERMABOND WAS PLACED ON THE DISTAL INCISION AND THE PATIENT WAS PLACED IN A KNEE IMMOBILIZER FOR THE WEEKEND AND PRESCRIBED PROPHYLACTIC ANTIBIOTICS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT FURTHER WOUND COMPLICATIONS

  Patient problems: Fluid Discharge

  MAUDE report 19315339 ↗
• InjuryJun 26, 2023Unstable; Migration; Unstable; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY THREE (3) MONTHS POST-IMPLANTATION, THE PATIENT EXPERIENCED MID-FLEXION INSTABILITY DUE TO EXCESSIVE INTERNAL ROTATION AND MISALIGNMENT OF THE TIBIAL TRAY. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR SYSTEM WITHOUT COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17198207 ↗
• InjuryJun 9, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FIVE MONTHS POST IMPLANTATION DUE TO TIBIAL LOOSENING. PATIENT HAD ONGOING PAIN AND SWELLING OF THE KNEE AFTER INITIAL SIX WEEK POST-OP PERIOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

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

  MAUDE report 17097949 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, AMBULATION DIFFICULTIES, AND INSTABILITY OF THE KNEE APPROXIMATELY 3 YEARS POST IMPLANTATION. NO REVISION PROCEDURE HAS BEEN SCHEDULED AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 14015126 ↗
• InjuryApr 21, 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: Bone Fracture(s)

  MAUDE report 11700447 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771, K173417. One submission often covers many models, so check the product and lot details in each record.

• Z-1917-2016 · May 11, 2016 · Terminated
  Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
• Z-1266-2015 · Jan 28, 2015 · Terminated
  Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in eit