DJO SURGICAL 412-02-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912077415), received between Nov 19, 2019 and Dec 4, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Unstable; Unstable

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 23723570 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PATIENT FELL POST OP.

  Patient problems: Insufficient Information

  MAUDE report 16315510 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT WAS FOUND IN THE BATHROOM COMPLAINING OF HIP PAIN. DIAGNOSED IN ER DISLOCATION (BALL AND HEAD STILL TOGETHER) ER TRIED TO REDUCE TOOK ANOTHER X-RAY AND NOTICED IMPLANT WAS DISLOCATED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 15576267 ↗
• InjuryNov 27, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT DEVELOPED AN INFECTION AFTER THE INDEX SURGERY. PATIENT WAS TAKEN TO OPERATING ROOM AND THE INDEX HEAD AND BIPOLAR COMPONENTS WERE REMOVED, THE JOINT IRRIGATED, AND NEW HEAD AND BIPOLAR COMPONENTS WERE ASSEMBLED AND IMPACTED ON THE STEM. WOUND WAS CLOSED IN A ROUTINE FASHION.

  Patient problems: Unspecified Infection

  MAUDE report 10913777 ↗
• InjurySep 16, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND NOTHING PUT BACK IN.

  Patient problems: Unspecified Infection

  MAUDE report 10541482 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - IRRIGATION AND DRAINAGE WASHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9341496 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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

…and 3 more.