RENOVATION 71369045Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010437617), received between Jun 18, 2020 and Apr 28, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K093047); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REVISION THR SURGERY, ONE (1) CEMENT DRILL 4.5MM FRACTURED WHILE DRILLING THROUGH THE CEMENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918491 ↗
• MalfunctionOct 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR REVISION SURGERY, WHEN REMOVING CEMENT FROM THE FEMORAL CANAL, THE CEMENT DRILL 4.5MM BREAK FROM IMPACT ON THE CEMENT. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. NO DELAY WAS REPORTED OR INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371172 ↗
• MalfunctionNov 1, 2023Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) CEMENT DRILL 4.5MM WAS FOUND BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18050181 ↗
• MalfunctionAug 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION SURGERY CONDUCTED TO REMOVE A COMPETITOR'S KNEE PROTHESIS, THE TIP OF A CEMENT DRILL 4.5MM FRACTURED WHILE USING THE DRILL ON THE TIBIA. THE SURGEON REMOVED THE DRILL TIP. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAY. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17456500 ↗
• InjuryAug 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR 2 STAGE REVISION (1 STAGE) PROCEDURE, WHILE SURGEON WAS IN THE PROCESS OF REMOVING CEMENT FROM THE FEMORAL CANAL WITH THE CEMENT DRILL 4.5MM FROM THE RENOVATION SET, THE DRILL TIP SNAPPED OFF. THIS CAUSED THE DEVICE BECAME LODGED IN THE FEMORAL CANAL. AN ATTEMPT WAS MADE TO RETRIEVE THE DRILL BIT INITIALLY, THE FLUOROSCOPY SHOWED THE DRILL TIP WEDGED BETWEEN A REVISION KNEE STEM AND THE FEMORAL CORTEX. SURGEON COMMENTED THAT THIS ADVERSE EVENT WOULD BE ADDRESSED DURING THE REVISION OF THE KNEE PROSTHESIS BY REMOVING THE BROKEN DRILL TIP. SURGERY WAS RESUMED, WITH MORE THAN AN ONE HOUR DELAY. IT IS UNKNOWN HOW SURGERY WAS FINISHED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 15316108 ↗
• MalfunctionMay 18, 2022Break; Break

  IT WAS REPORTED THAT AFTER THR, THE CEMENT DRILL 4.5MM WAS FOUND TO BE BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432240 ↗
• MalfunctionMay 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SET UP FOR A THR SURGERY, THE CEMENT DRILL 4.5MM SNAPPED IN HALF. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAYS AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432235 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT A CEMENT DRILL 4.5MM ((B)(6)) BROKE INSIDE THE PATIENT, A RONGEUR 300MM WITH TEETH ((B)(6)) AND A RONGEUR 200MM WITH TEETH ((B)(6)) ARE BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002201 ↗
• InjuryJun 18, 2020Break; Break

  IT WAS REPORTED THAT DURING THR REVISION SURGERY (IT IS UNKNOWN IF WAS A REVISION SURGERY OF SMITH AND NEPHEW DEVICES), WHILE USING THE DRILL TO DRILL THROUGH A CEMENT MANTLE IN THE FEMUR, THE TIP OF THE CEMENT DRILL BROKE OFF. THE PROCEDURE WAS FINISHED WITH A CHANGE IN THE SURGICAL TECHNIQUE. THERE WAS NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10166343 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434