DJO SURGICAL 412-02-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912077453), received between Nov 15, 2019 and Dec 28, 2023 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - FALL LOWER BODY COMPONENT AND LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 18415520 ↗
• InjuryJul 10, 2020Unstable

  REVISION SURGERY - DUE TO INSTABILITY REVISED THE BIPOLAR TO A TOTAL HIP .

  Patient problems: No Code Available

  MAUDE report 10257507 ↗
• InjuryJun 17, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - UNKNOWN REASONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10163142 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9733260 ↗
• InjuryNov 15, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO IRRIGATION AND DRAINAGE WASHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9328598 ↗

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-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-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
• 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-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-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-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-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-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-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-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-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-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-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

…and 3 more.