DJO SURGICAL 425-98-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912078788), received between Jul 26, 2017 and Jan 10, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K120241); 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO SUBSIDENCE AND FRACTURE.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 21132043 ↗
• InjuryMay 8, 2019Unstable

  REVISION SURGERY - DUE TO THE PATIENT BEING UNSTABLE, PAINFUL, LOSS OF MOTION.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 8591350 ↗
• InjuryJan 2, 2019Unstable

  REVISION SURGERY - THE PATIENT AND DOCTOR FOUND THE PRIMARY STEM'S STABILITY TO BE NOT TO THE PATIENTS LIKING AND IT WAS DECIDED TO REMOVE THE STEM AND REPLACE IT WITH AN EXPERT REVISION HIP STEM.

  Patient problems: No Code Available

  MAUDE report 8210598 ↗
• InjuryApr 10, 2018Fracture

  REVISION SURGERY - DUE TO THE PATIENT FRACTURING AROUND THE FEMORAL PROSTHESIS A FEW DAYS AFTER PRIMARY TOTAL HIP ARTHROPLASTY. THE SURGEON REMOVED THE ORIGINAL STEM AND A REVISION PROSTHESIS WAS IMPLANTED WITH CABLES TO SECURE FRACTURE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7412843 ↗
• InjuryJul 26, 2017Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT DISLOCATING IN POST OP.

  Patient problems: Failure of Implant; Joint Dislocation; No Code Available

  MAUDE report 6744643 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120241. One submission often covers many models, so check the product and lot details in each record.

• Z-1692-2020 · Jul 10, 2018 · Open, Classified
  djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The