DJO SURGICAL 412-02-043Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912077354), received between Dec 10, 2021 and Dec 10, 2021 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2021Unstable

  REVISION SURGERY - CONVERTED BIPOLAR HIP TO TOTAL HIP, DUE TO INSTABILITY.

  Patient problems: Insufficient Information

  MAUDE report 12976162 ↗

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-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-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-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-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-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-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
• 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-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-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-0099-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; 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-0082-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; 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-0091-2008 · Aug 2, 2007 · Terminated
  Foundation Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 7

…and 3 more.