Oxford Partial Knee SystemFemoral Impactor 32-420127Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05019279477333), received between Apr 29, 2020 and Sep 28, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fracture

  It was reported that the black impactor shattered into multiple pieces when it was placed in a bucket after the surgery. There was no patient involvement. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912335 ↗
• MalfunctionJul 3, 2026Fracture

  IT WAS REPORTED THAT THE DISTAL POINT OF AN IMPACTOR WAS CHIPPED. THERE WAS NO IMPACT TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701873 ↗
• MalfunctionJun 15, 2026Fracture

  IT WAS REPORTED THAT THE PLASTIC PART OF A FEMORAL IMPACTOR CHIPPED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499392 ↗
• MalfunctionMar 23, 2026Fracture

  IT WAS REPORTED THAT AFTER THE SURGERY, THE CUSTOMER NOTICED THAT THE TIP OF THE FEMORAL IMPACTOR WAS DAMAGED (WORN). NO INTRAOPERATIVE IMPACT OR INCIDENT WAS REPORTED, AS THE DAMAGE WAS IDENTIFIED ONLY AFTER THE PROCEDURE HAD BEEN COMPLETED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661763 ↗
• MalfunctionFeb 24, 2026Fracture; Material Deformation; Sharp Edges

  IT WAS REPORTED THAT THE EDGE OF A METAL HANDLE DEFORMED AND BECAME SHARP AND HAZARDOUS TO THE USER, AND THE PLASTIC IMPACTOR END ALSO DEFORMED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427497 ↗
• MalfunctionDec 16, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING SURGERY, EDGES OF THE FEMORAL IMPACTOR DETACH WHEN IMPACTING THE MICRO ANTI-IMPINGEMENT GUIDE AND FALL INTO THE SURGICAL SITE. THERE WAS NO HARM TO THE PATIENT AND NO DELAY IN THE PROCEDURE. ALL RESIDUES COULD BE REMOVED FROM THE SURGICAL WOUND WITHOUT EXCEPTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813516 ↗
• MalfunctionDec 10, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766344 ↗
• MalfunctionDec 10, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766338 ↗
• MalfunctionDec 10, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766336 ↗
• MalfunctionNov 3, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448273 ↗
• MalfunctionSep 19, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN AT THE END OF A SURGERY NURSE UNSCREWED THE HEAD OF IMPACTOR, SHE SAW A PIECES OF METAL FROM THE SHAFT COMING OFF, FROM THE SCREWING THREADS. THERE WAS NO HARM TO THE PATIENT, NO FOREIGN BODY RETAINED. UPON INVESTIGATION IT WAS DETERMINED THAT PRODUCT EXHIBITS SIGNS OF USE, GOUGES, ON THE PAD, NO DAMAGE TO THREADS OR ANY OTHER PART OF THE HANDLE OTHER THAN TOOL MARKS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093804 ↗
• MalfunctionApr 4, 2025Crack; Fracture; Crack; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771357 ↗
• MalfunctionSep 27, 2021Break; Fracture; Naturally Worn; Break; Fracture; Naturally Worn

  IT WAS REPORTED THAT DURING IMPACTION OF THE FEMUR, THE PLASTIC OF THE IMPACTOR BROKE OFF AND HAS HAD TO BE REPLACED. NOTHING FELL INTO THE PATIENT AND NO HARM WAS REPORTED. SURGERY COMPLETED WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532044 ↗
• MalfunctionApr 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING KNEE ARTHROPLASTY PERFORMED ON (B)(6) 2020, THE FEMORAL IMPACTOR FRACTURED. NO PART REMAINED IN THE SURGERY AREA OR SITUS.

  Patient problems: Joint Dislocation

  MAUDE report 10008765 ↗