Persona® Trabecular Metal® 42-5028-070-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024230842), received between Feb 5, 2021 and Jan 26, 2026 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (2 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Packaging Problem

  IT WAS REPORTED THE IMPLANT PACKAGING APPEARED TO BE MELTED PRIOR TO USE. THE DEVICE WAS NOT USED AND A SECONDARY IMPLANT WAS RETRIEVED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182919 ↗
• InjuryJan 6, 2026Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening

  MAUDE report 23980298 ↗
• MalfunctionNov 24, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE IMPLANT PACKAGING APPEARED TO BE MELTED PRIOR TO USE. THE DEVICE WAS NOT USED AND A SECONDARY IMPLANT WAS RETRIEVED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639407 ↗
• MalfunctionNov 14, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556363 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FURTHER INFORMATION REGARDING THE EVENT INDICATED THAT 1 PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO LIMITED RANGE OF MOTION. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 22386734 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 5 WEEKS POST-OPERATIVE, THE PATIENT BEGAN TO EXPERIENCE SEVERE PAIN APPROXIMATELY. AT THE NINE MONTH POST-OPERATIVE FOLLOW-UP APPOINTMENT, THE PATIENT REPORTED SEVERE PAIN AND DIFFICULTIES WITH AMBULATION AND ADLS. ALL RADIOGRAPHIC IMAGING DISPLAYED NO SIGNIFICANT FINDINGS AND THE KNEE WAS STABLE UPON ASSESSMENT. A BRACE WAS GIVEN AT THE 9 MONTH FOLLOW-UP TO RULE OUT ANY INSTABILITY THAT COULD BE CONTRIBUTING TO THE ONGOING PAIN. ALL PRODUCTS REMAIN IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 22009035 ↗
• InjuryJun 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 2 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO FEMORAL AND TIBIAL LOOSENING, FLEXION INSTABILITY, AND PAIN. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 19605180 ↗
• InjuryMay 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A REVISION APPROXIMATELY THREE (3) YEARS POST-IMPLANTATION DUE TO INSTABILITY AFTER THE PATIENT HAD A FALL WITH A LATERAL SOFT TISSUE INJURY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 19271895 ↗
• InjuryJun 6, 2022Material Erosion; Unstable; Adverse Event Without Identified Device or Use Problem; Material Erosion; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TKA WITH DR (B)(6) -STANDARD PRIMARY WITH CONE. SCREW BELOW IMPLANT THAT COULDN¿T BE REMOVED SO NO STEM USED. PATIENT HAD BECOME VERY UNSTABLE LATERALLY SO CAME FOR REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION. ONCE OPENED UP WE FOUND POLY HAD BE SMASHED ON THE POSTERIOR MEDIAL CORNER. IT WAS HYPOTHESISED THAT MAYBE THE TIBIAL TRAY WAS KICKED INTO TOO MUCH EXTERNAL ROTATION WHICH CAUSED THE FEMUR TO CONTACT MORE POSTERIOR AND THE PATIENT MAY HAVE SUBLUXED POSTEROMEDIALLY. THERE WAS METALOSSIS IN THE JOINT FROM THE FEMUR RUBBING ON THE TIBIAL COMPONENT AS SEEN IN THE ATTACHED PICTURE OF EXPLANTED TIBIA. CONE WAS REMOVED AS WE COULDN¿T FIX ROTATION. COMPETITOR PRODUCT PERIMETER CONE USED WITH PRIMARY BASEPLATE AND STUBBY STEM AND ROTATION WAS CHANGED TO IMPROVE CONTACT POINT.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 14604218 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. IT WAS REPORTED THAT THE PATIENT DEVELOPED A DEEP VEIN THROMBOSIS APPROXIMATELY 3 DAYS POST IMPLANTATION. THE PATIENT WAS TREATED MEDICALLY AND ISSUE RESOLVED, WITH COMPONENTS REMAINING IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13595365 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL KNEE ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED DUE TO INFECTION ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11647656 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY FOR LYSIS OF ADHESIONS APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUD TO PAIN, LIMITED MOBILITY, STIFFNESS, AND ADHESIONS. THE PATIENT CONTINUES TO REPORT PAIN AND STIFFNESS. OUTCOME IS PENDING.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Pain

  MAUDE report 11285655 ↗