DJO SURGICAL 600-15-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00190446138006), received between Jan 7, 2019 and Oct 22, 2021 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 18, 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.

• InjuryOct 22, 2021Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY: INFECTED REMOVED ALL IN 2 STAGE CEMENT SPACER INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 12686421 ↗
• InjuryMay 28, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT HAD A TOTAL KNEE ARTHROPLASTY WITH COBALT BONE CEMENT. PATIENT EXPERIENCED SWELLING, PAIN AND A HEMATOMA. PATIENT SUBSEQUENTLY SOUGHT TREATMENT FROM ANOTHER PROVIDER AND HAD REVISION SURGERY. THE FEMUR WAS REPORTED TO BE LOOSE.

  Patient problems: Hematoma; Pain; Swelling/ Edema

  MAUDE report 11901604 ↗
• InjuryMay 25, 2021Material Too Rigid or Stiff; Temperature Problem

  PRIMARY SURGERY - SURGEON IS CONCERNED BECAUSE THE CEMENT WAS ROCK HARD IN 7:38 MINUTES. HE HAS BEEN A COBALT CEMENT USER SINCE BIOMET BROUGHT IT TO MARKET. THE ROOM WAS 64 DEGREES, CEMENT OPENED AT THE TIME OF THE CASE AND WAS NOT WARMED UP IN ANY WAY. THIS WAS A CEMENTED HIP AND THE STEM ENDED UP 5MM PROUD.

  Patient problems: Insufficient Information

  MAUDE report 11878085 ↗
• InjuryFeb 17, 2021Patient-Device Incompatibility

  REPORTED INCIDENT - PATIENT BEGAN EXPERIENCING SEVERE AND PERSISTENT PAIN, DISCOMFORT, INSTABILITY AND DIFFICULTY AMBULATING CAUSED BY MECHANICAL LOOSENING OF THE DEFECTIVE COBALT HV BONE CEMENT.

  Patient problems: Pain

  MAUDE report 11337768 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem

  REPORTED INCIDENT - A PATIENT HAD AN INITIAL LEFT UNILATERAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED A SUPERFICIAL WOUND INFECTION OF THE LEFT KNEE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10510103 ↗
• InjuryJun 11, 2020Fire

  PRIMARY SURGERY - THE PHYSICIAN WAS IMPACTING THE TIBIA COMPONENT USING THE APPROPRIATE MALLET THE CEMENT IGNITED NOT SURE OF CAUSE OF IGNITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10144593 ↗
• MalfunctionApr 10, 2019Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  COMPLAINT - THE OUTER PACKAGING IS TEARING AND CONTAMINATING THE STERILE PACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8502316 ↗
• MalfunctionMar 13, 2019Material Split, Cut or Torn

  PRODUCT PROBLEM - THE TYVEK MATERIAL IS TEARING WHEN OPENING TO STERILE FIELD, DURING OPENING OF THE INNER POUCH PEALING.

  Patient problems: No Information

  MAUDE report 8417259 ↗
• InjuryMar 1, 2019Contamination /Decontamination Problem; Device Handling Problem

  COMPLAINT - 3 BOXES OF THE SAME LOT NUMBER DIDN'T OPEN THE CORRECT WAY RESULTING IN CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8381888 ↗
• MalfunctionFeb 27, 2019Material Split, Cut or Torn

  COMPLAINT - WHILE OPENING THE PACKAGING TORE THROUGH THE STERILE PACK DUE TO PACKAGING MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8376012 ↗
• MalfunctionJan 7, 2019Contamination; Material Discolored; Peeled/Delaminated

  COMPLAINT - DUE TO THE STERILE PACK NOT OPENING PROPERLY. PAPER LINER SHREDDED WHEN OPENED. POSSIBILITY OF CONTAMINATING POWDER POUCH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8222327 ↗