RENOVATION 71367553Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010403025), received between Jun 8, 2021 and Jul 2, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2021Break; Break

  IT WAS REPORTED THAT, DURING A REVISION SURGERY FOR A THR DUE TO INFECTION, IN ONE (1) LARGE SLAP HAMMER THE CONNECTION TO THE TRUNNION BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111738 ↗
• InjuryJun 8, 2021Break; Break

  IT WAS REPORTED THAT DURING A REVISION SURGERY (COMPETITOR'S DEVICES) FOR A THR, THE ATTACHMENT FROM THREE LARGE SLAP HAMMERS TO THE TRUNNION OF THE STEM GAVE WAY INSIDE THE PATIENT WHILE TRYING TO EXTRACT A COMPETITIVE FEMORAL STEM. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962834 ↗
• InjuryJun 8, 2021Break; Break

  IT WAS REPORTED THAT DURING A REVISION SURGERY (COMPETITOR'S DEVICES) FOR A THR, THE ATTACHMENT FROM THREE LARGE SLAP HAMMERS TO THE TRUNNION OF THE STEM GAVE WAY INSIDE THE PATIENT WHILE TRYING TO EXTRACT A COMPETITIVE FEMORAL STEM. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962818 ↗
• InjuryJun 8, 2021Break; Break

  IT WAS REPORTED THAT DURING A REVISION SURGERY (COMPETITOR'S DEVICES) FOR A THR, THE ATTACHMENT FROM THREE LARGE SLAP HAMMERS TO THE TRUNNION OF THE STEM GAVE WAY INSIDE THE PATIENT WHILE TRYING TO EXTRACT A COMPETITIVE FEMORAL STEM. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962810 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116