DJO SURGICAL 412-02-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912077378), received between Jun 19, 2017 and Apr 15, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Device Dislodged or Dislocated

  REVISION SURGERY DUE TO PATIENT HAD DISLOCATED POST-OPERATIVELY.

  Patient problems: Joint Dislocation

  MAUDE report 24891967 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO FALL LOWER BODY/DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 20036341 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - MDR - FALL LOWER BODY COMPONENT/DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 17909732 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17262700 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - FALL LOWER BODY COMPONENT/DISLOCATION.

  Patient problems: Fall

  MAUDE report 17083757 ↗
• InjuryJun 14, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14690236 ↗
• InjuryJun 1, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT HAD AN INFECTION. SURGEON REMOVED THE BALL AND SHELL, THEN EVALUATED THE STEM AND THEN DID A THOROUGH WASHOUT OF THE JOINT. SURGEON REPLACED THE BALL AND SHELL WITH A NEW BALL AND SHELL.

  Patient problems: Unspecified Infection

  MAUDE report 14569820 ↗
• InjuryNov 16, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 10843875 ↗
• InjurySep 3, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10488582 ↗
• InjuryAug 24, 2020Unstable

  REVISION SURGERY - PATIENT HAS A DJO HEMI-ARTHROPLASTY THAT SURGEON REVISED FOR INSTABILITY, SHE WAS DONE OUT OF STATE. HE ANTICIPATE GOING UP ON NECK LENGTH AND DECREASING THE SIZE OF HEAD 1-2 MM.

  Patient problems: No Code Available

  MAUDE report 10442768 ↗
• InjuryMar 21, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT BEING CONVERTED FROM A BIPOLAR HIP TO A TOTAL HIP.

  Patient problems: No Code Available

  MAUDE report 7357335 ↗
• InjuryMar 5, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT NOT FOLLOWING SURGEON'S INSTRUCTIONS, AND DISLOCATING BIPOLAR FROM HIP SOCKET AFTER CROSSING HER LEGS. EMERGENCY ROOM SURGEON DISENGAGED HEAD FROM STEM WHILE TRYING TO REDUCE. A LONGER NECK AND OFFSET STEM WERE ADDED.

  Patient problems: No Code Available

  MAUDE report 7313538 ↗
• InjuryAug 25, 2017Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT FALLING; THE SURGEON PERFORMED A WASHOUT AND CHANGED THE IMPLANTS.

  Patient problems: Fall

  MAUDE report 6820557 ↗
• InjuryJun 19, 2017Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THE SURGEON REMOVED AND REPLACED THE HEAD AND BIPOLAR.

  Patient problems: Unspecified Infection

  MAUDE report 6650354 ↗

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

…and 3 more.