DJO SURGICAL 425-99-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912078986), received between Jul 20, 2018 and Mar 5, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO FRACTURE.

  Patient problems: Limb Fracture

  MAUDE report 18838656 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 17733789 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT HAD A PRIMARY TOTAL HIP. PRESENTED AT SURGEON OFFICE WITH A LEG LENGTH DISCREPANCY. AN XRAY REVEALED THAT THE LINEAR STEM HAD SUBSIDED 1CM. THE SURGEON SCHEDULED A REVISION TOTAL HIP FOR DATE. DURING THE REVISION, HE REMOVED THE SIZE 12 LATERAL OFFSET LINEAR STEM, 36MM FEMORAL HEAD AND -3.5MM OFFSET SLEEVE. HE BROACHED UP TO A SIZE 15 LINEAR WHICH WAS MORE STABLE IN THE FEMORAL CANAL. HE IMPLANTED A SIZE 15 LINEAR STEM, 36MM FEMORAL HEAD AND A NEUTRAL OFFSET SLEEVE. THERE WERE NO ISSUES DURING THE REVISION.

  Patient problems: Joint Laxity

  MAUDE report 15692415 ↗
• InjuryMay 11, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT HAS TERRIBLE BONE. THE SURGEON FRACTURED THE FEMUR AS HE WAS INSERTING THE STEM. BECAUSE THE FEMUR WAS FRACTURED DURING THE PRIMARY SURGERY AND IMPLANTED COMPONENTS HAD TO BE REMOVED, IT TURNED INTO A REVISION SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 14364632 ↗
• InjuryJul 20, 2018Fracture

  REVISION SURGERY - DUE TO THE PATIENT HAVING A PERI PROSTHETIC FRACTURE.

  Patient problems: No Code Available

  MAUDE report 7707624 ↗

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