PREP-IM 121010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010457127), received between Mar 31, 2019 and Feb 2, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Delivered as Unsterile Product; Device Damaged Prior to Use

  IT WAS REPORTED THAT WHEN VERIFYING HIS ORDER, THE CUSTOMER IDENTIFIED THAT TWO (2) PREP IM ENCHANCE TOTAL HIP KIT WERE DAMAGED AND APPEARED TO HAVE BEEN DE-STERILIZED, RENDERING THEM UNUSABLE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233336 ↗
• MalfunctionAug 25, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, DURING SET UP FOR A THR, IT WAS NOTICED THAT THE OUTER PACKAGING OF ONE (1) PREP IM ENCHANCE TOTAL HIP KIT WAS SEVERELY DAMAGED, IT WAS TORN AND HAD HOLES, ALLOWING THE PRODUCT TO NO LONGER BE STERILE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883797 ↗
• MalfunctionSep 2, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT WHEN 2 BOXES OF PREP IM ENCHANCE TOTAL HIP KIT WERE RECEIVED, THEY WERE BROKEN AND OPEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20117930 ↗
• MalfunctionFeb 28, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, WHEN A BOX OF PREP IM ENHANCE TOTAL HIP KIT WAS RECEIVED IN A CARE UNIT, THE CARDBOARD BOX WAS INTACT BUT THE INSIDE BLISTER PACK WAS DEFECTIVE. THE OUTER AND INNER TRAY WERE BOTH DELIVERED BROKEN OFF. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800573 ↗
• MalfunctionNov 30, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP FOR A TKA SURGERY, WHEN A NEW PACKING WAS OPENED, THE OUTER BOX WAS NOT COMPROMISED BUT ALL (FIVE) INNER PREP IM ENCHANCE TOTAL HIP KIT PACKAGES WERE CRACKED AND STERILIZATION WAS COMPROMISED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237475 ↗
• MalfunctionOct 23, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, THE MEDICAL DEVICE PACKAGING OF THREE (3) PREP IM ENCHANCE TOTAL HIP KIT WAS FOUND DAMAGED IN ITS STORAGE BOX, WITH THE DOUBLE PACKAGING BROKEN AND THEREFORE UNUSABLE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986142 ↗
• MalfunctionMay 6, 2023Crack; Delivered as Unsterile Product; Crack; Delivered as Unsterile Product

  IT WAS REPORTED THAT, THE PACKAGING OF MANY UNITS OF PREP IM ENCHANCE TOTAL HIP KIT WERE FOUND TO BE CRACKED, CONTAMINATING THE INNER CONTENTS. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883113 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE FLEXIBLE GREEN BUCKS CEMENT ON THE PREP IM ENCHANCE TOTAL HIP KIT BROKE WHILE SURGEON WAS INSERTING THE CEMENT RESTRICTORS. THERE WAS A DELAY LESS THAN 30 MINUTES BECAUSE SURGEON HAD TO REMOVE THE BROKEN PIECE FROM THE FEMORAL CANAL. PATIENT WAS NOT HARMED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850007 ↗
• InjuryApr 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A LEFT SIDE THA AT (B)(6) PUBLIC (B)(6) 2019 WITH A SPECTRON/POLARCUP CONSTRUCT VIA A POSTERIOR APPROACH. PATIENT HAS MEDICAL HISTORY OF KIDNEY TRANSPLANT. PATIENT LEFT HIP WOUND WOULD NOT HEAL AND WAS INFECTED. PATIENT HAD A WASHOUT AND DEBRIDEMENT (DONE BY ANOTHER SURGEON) AS WELL AS VAC DRESSINGS, PRIOR TO FIRST STAGE REVISION ON (B)(6) 2019. DR. PERFORMED FIRST STAGE REVISION HIP SURGERY ON (B)(6) 2019 REMOVING ACETABULAR IMPLANTS WITH ZIMMER EXPLANT AND USING RENOVATION HIP TO REMOVE FEMORAL COMPONENT. SURGEON PERFORMED AN ETO AND REMOVED CEMENT FROM FEMUR WITH RENOVATION INSTRUMENTS. ACETABULUM REAMED AND FEMUR REAMED. WOUND DEBRIDED AND IRRIGATED WITH SALINE AND BETADINE AND FEMUR CABLED WITH CIRCLAGE WIRE TEMPORARILY. WOUND CLOSED, AND THEN PT RE-PREPPED AND DRAPED WITH WHOLE NEW SETUP. PT THEN REOPENED AND THEN DALLMILES CABLES APPLIED TO FEMUR AND ZB HIP CEMENT SPACER INSERTED WITH PALACOS COPAL CEMENT LOADED WITH ANTIBIOTIC USED TO FIX HIP CEMENT SPACER. WOUND IRRIGATED AND CLOSED IN LAYERS.

  Patient problems: Unspecified Infection

  MAUDE report 8489189 ↗
• InjuryMar 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. PATIENT LEFT HIP WOUND WOULD NOT HEAL AND WAS INFECTED. PATIENT HAD A WASHOUT AND DEBRIDEMENT PRIOR TO FIRST STAGE REVISION ON (B)(6) 2019, ACETABULAR IMPLANTS AND FEMORAL COMPONENT WERE REMOVED. ANTIBIOTIC CEMENT SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 8468041 ↗