Persona® Trabecular Metal® 42-5450-010-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024560789), received between Apr 1, 2022 and Apr 30, 2026 — classified as 9 injuries.

1 other recall cover devices cleared under the same FDA submission (K181947, K191625); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT RIGHT KNEE A TWO-STAGE REVISION FOR INFECTION. APPROXIMATELY SEVEN MONTHS LATER THE PATIENT BEGAN TO HAVE INTERMITTENT PAIN AND SWELLING. TWO YEARS AND FIVE MONTHS LATER THE PATIENT REPORTED AN INCREASE IN PAIN AND WAS PRESCRIBED PHYSICAL THERAPY. ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 25045531 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN APPROXIMATELY TWO (2) YEARS FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT WAS INSTRUCTED TO CONTINUE OVER-THE-COUNTER PAIN-RELIEVERS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 21650741 ↗
• InjurySep 17, 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: Bone Fracture(s); Fall; Pain; Swelling/ Edema

  MAUDE report 20238800 ↗
• InjurySep 17, 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: Bone Fracture(s); Fall; Pain; Swelling/ Edema

  MAUDE report 20238784 ↗
• InjurySep 17, 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: Bone Fracture(s); Fall; Pain; Swelling/ Edema

  MAUDE report 20238783 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT RIGHT KNEE A TWO STAGE REVISION FOR INFECTION. SUBSEQUENTLY, APPROXIMATELY 7 MONTHS LATER THE PATIENT BEGAN TO HAVE INTERMITTENT PAIN AND SWELLING AND 2 YEARS FIVE MONTHS REPORTED AN INCREASE IN PAIN AND WAS PRESCRIBED PHYSICAL THERAPY. ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19139731 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH TOPICAL AGENTS, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, AND NARCOTICS TO ADDRESS LIMITED RANGE OF MOTION AND PERSISTENT MODERATE PAIN APPROXIMATELY TWO (2) YEARS FOLLOWING THE PATIENT'S LAST RIGHT KNEE ARTHROPLASTY. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE. OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 18730349 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY WITH UNKNOWN PRODUCT. THE PATIENT WAS REVISED APPROXIMATELY 1.5 YEARS LATER DUE TO IMPLANT LOOSENING. AT THE 1 YEAR FOLLOW UP, THE PATIENT PRESENTED WITH LEFT LATERAL KNEE PAIN THAT RADIATES TO LOWER LEG. NARCOTICS WERE PRESCRIBED. AT THE 2 YEAR FOLLOW UP APPOINTMENT. A LARGE LEFT KNEE EFFUSION WAS PRESENT. LEFT KNEE ASPIRATION WAS COMPLETED IN THE OFFICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15978579 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST-IMPLANTATION, THE PATIENT REPORTS PERSISTENT PAIN. RADIOLOGY RESULTS REVEAL INCREASED RADIOLUCENCY CONCERNING FOR LOOSENING OF THE TIBIA AND A STABLE PERIPROSTHETIC FRACTURE AT THE LATERAL FEMORAL CONDYLE. DUE TO THE BONE LOSS FROM TWO PRIOR REVISIONS, THE PATIENT DOES NOT WANT TO PURSUE ANOTHER REVISION AND WILL BE TREATED CONSERVATIVELY AT THIS TIME.

  Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis; Pain

  MAUDE report 13977954 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181947, K191625. One submission often covers many models, so check the product and lot details in each record.

• Z-2578-2026 · May 11, 2026 · Open, Classified
  Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: