DJO SURGICAL 412-02-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912077460), received between Apr 22, 2016 and Jun 14, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

18 other recalls cover devices cleared under the same FDA submission (K953510); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2026Device Dislodged or Dislocated

  REVISION SURGERY DUE TO DISLOCATION.

  Patient problems: Joint Laxity

  MAUDE report 25497792 ↗
• InjuryJun 8, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT HAD INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11961666 ↗
• InjuryNov 13, 2017Material Protrusion/Extrusion

  REVISION SURGERY - DUE TO THE PATIENT HAVING BIPOLAR HEAD PROTRUSION, SO THE SURGEON REMOVED THE BIPOLAR AND REPLACED WITH A CAGE. THE CAGE WAS NOT SUFFICIENT, SO HE REPLACED WITH A 60 BIPOLAR HEAD.

  Patient problems: Failure of Implant

  MAUDE report 7026259 ↗
• InjuryApr 22, 2016Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT'S HIP DISLOCATING.

  Patient problems: No Code Available

  MAUDE report 5599061 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953510. One submission often covers many models, so check the product and lot details in each record.

• Z-0092-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0085-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0096-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0090-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0089-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0083-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0094-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0093-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0087-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0086-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0084-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0098-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0095-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0097-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7
• Z-0088-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7

…and 3 more.