DJO SURGICAL 412-02-047Recalls & reported problems
Encore Medical, L.P. · SHELL, BIPOLAR, MODULAR, ENCORE, SIZE47 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912077385), received between Sep 29, 2015 and Jun 13, 2023 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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
Device problems
- Device Dislodged or Dislocated3
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Insufficient Device Problem Information1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant2
- No Code Available2
- Unspecified Infection2
- Fall1
- Joint Dislocation1
- Pain1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 19, 2022Appropriate Device Problem Term/Code Not Available
InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - SURGEON REVISED THE PATIENT FOR INFECTION. HE REMOVED THE BIPOLAR COMPONENT AND 28MM INNER HEAD.
Patient problems: Unspecified Infection
MAUDE report 12618968 ↗InjuryApr 5, 2021Device Dislodged or Dislocated
REVISION SURGERY - THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A HIP DISLOCATION. THE ORIGINAL SURGEON APPLIED A CLOSED REDUCTION, BUT THAT REDUCTION ONLY LASTED A FEW DAYS BEFORE SHE WAS ADMITTED A SECOND TIME DUE TO ANOTHER DISLOCATION. THAT IS WHEN IT WAS DETERMINED TO REVISE THE PROSTHESIS.
Patient problems: Failure of Implant
MAUDE report 11614866 ↗InjuryDec 26, 2017Patient-Device Incompatibility; Device Dislodged or Dislocated
InjuryFeb 3, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE HEAD DISLOCATING FROM THE STEM AND THE SURGEON REPLACING THE HEAD.
Patient problems: No Code Available
MAUDE report 6301807 ↗InjuryDec 21, 2015Insufficient Device Problem Information
REVISION SURGERY - DUE TO A BIPOLAR INFECTION, THE SURGEON PERFORMED A WASH OUT AND EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 5313832 ↗InjurySep 29, 2015Break
REVISION SURGERY - DUE TO THE PATIENT FALLING AND BREAKING THEIR FEMUR. THE SURGEON REMOVED ALL OT THE ORIGINAL IMPLANTS AND HAD TO PUT IN A LONG STEM.
Patient problems: Fall; No Code Available
MAUDE report 5112253 ↗
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 · TerminatedFoundation 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-0083-2008 · Aug 2, 2007 · TerminatedFoundation 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 · TerminatedFoundation 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-0096-2008 · Aug 2, 2007 · TerminatedFoundation 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-0099-2008 · Aug 2, 2007 · TerminatedFoundation 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-0086-2008 · Aug 2, 2007 · TerminatedFoundation 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-0087-2008 · Aug 2, 2007 · TerminatedFoundation 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-0089-2008 · Aug 2, 2007 · TerminatedFoundation 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-0094-2008 · Aug 2, 2007 · TerminatedFoundation 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-0098-2008 · Aug 2, 2007 · TerminatedFoundation 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-0085-2008 · Aug 2, 2007 · TerminatedFoundation 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 · TerminatedFoundation 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-0097-2008 · Aug 2, 2007 · TerminatedFoundation 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 · TerminatedFoundation 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-0092-2008 · Aug 2, 2007 · TerminatedFoundation 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.
Other Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page