DJO SURGICAL 412-02-041Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912077330), received between Jan 4, 2017 and Jan 4, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• InjuryJan 4, 2017Detachment Of Device Component

  REVISION SURGERY - DUE TO THE PATIENT COMING INTO THE EMERGENCY ROOM (ER) WITH A DISLOCATED HEMI HIP THAT WAS ORIGINALLY IMPLANTED (B)(6) 2016. WHILE ATTEMPTING TO REDUCE THE HIP IN THE ER THE BIPOLAR HEAD DISASSOCIATED FROM THE FEMORAL HEAD STILL ENGAGED ON THE FEMORAL STEM. THE SURGEON ELECTED TO USE A NEW BIPOLAR COMPONENT IN CASE THE LOCKING MECHANISM WAS COMPROMISED.

  Patient problems: No Code Available

  MAUDE report 6221892 ↗

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

…and 3 more.