RENOVATION 71369007Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010437631), received between Mar 11, 2018 and Oct 9, 2020 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2020Break; Break

  IT WAS REPORTED THAT DURING THR PROCEDURE THE CONICAL TAP 7MM BROKEN. NO DELAY OR HARM TO THE PATIENT REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10655908 ↗
• InjuryOct 7, 2020Break; Break

  IT WAS REPORTED THAT DURING USED IN REVISION HIP CONICAL TAP 7MM BROKE INSIDE THE PATIENT THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO PATIENT INJURIES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10645425 ↗
• InjuryAug 20, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE TIP OF THE CONICAL TAP 7MM BROKE INSIDE OF THE PATIENT. THE PIECE COULD NOT BE RECOVERED. A REVISION SURGERY WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10434810 ↗
• MalfunctionFeb 21, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY AFTER DRILLING PILOT HOLE AND SCREWING IN TAP, TIP OF TAP BROKE OFF IN PATIENT. DOCTOR HAD TO SPEND AN EXTRA HOUR REMOVING IT. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9741841 ↗
• MalfunctionAug 12, 2019Break; Break

  IT WAS REPORTED THAT THE TIP BROKE INTRA-OPERATIVE INSIDE THE DISTAL FEMORAL (RIGHT FEMORAL CANAL) CANAL OF THE PATIENT DUE TO WEAR AND TEAR. THE SURGEON HAD TO OPERATE LONGER TO TRY AND REMOVE THE PARTIAL INSTRUMENT. DELAY OF 25 MINUTES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8883004 ↗
• InjuryFeb 8, 2019Break; Break

  IT WAS REPORTED THAT THE TIP OF THE RENOVATION CONICAL TAP BROKE OFF. ACCORDING TO THE SALES REP. THIS IS COMMON WHEN THE REMOVAL IS ASSOCIATED WITH CEMENT. NO MORE INFORMATION SHOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8323798 ↗
• MalfunctionFeb 8, 2019Break; Break

  IT WAS REPORTED THAT WHILE REMOVING CEMENT THE TIP OF THE RENOVATION CONICAL TAP BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8323690 ↗
• MalfunctionNov 15, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT, DURING REVISION SURGERY OF STEM, WHILE REMOVING BONE CEMENT (VERY GENTLY) FROM THE CANAL, THE DISTAL PART OF THE INSTRUMENT WAS BROKEN. A BROKEN PART WAS LEFT IN THE CANAL, LOCATION CONFIRMED BY X-RAYS. AS IT WAS NOT POSSIBLE TO IMPLANT A LONG REVISION STEM, A SHORT ONE WAS USED INSTEAD. THERE WAS A DELAY LONGER THAN 30 MINUTES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8074436 ↗
• MalfunctionMay 4, 2018Break; Break

  IT WAS REPORTED THAT A 7MM CONICAL TAP INSTRUMENT SNAPPED AT THE DISTAL TIP (APPROX. 2-3CM) DURING A REVISION HIP SURGERY. SURGEON ATTEMPTED TO RETRIEVE BROKEN TIP WITH VARIOUS GRASPERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7485983 ↗
• InjuryApr 12, 2018Break; Break

  IT WAS REPORTED THAT THE TIP BROKE OFF INSIDE THE FEMUR. THE TIP COULD NOT BE RETRIEVED AND SO WAS LEFT IN SITU IN THE PATIENT.

  Patient problems: Injury

  MAUDE report 7426235 ↗
• InjuryMar 11, 2018Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON BROKE THE TIP OF THE INSTRUMENT IN THE FEMUR AND WAS UNABLE TO REMOVE IT.

  Patient problems: Injury

  MAUDE report 7329835 ↗