DJO SURGICAL 412-02-045Recalls & reported problems
Encore Medical, L.P. · SHELL, BIPOLAR, MODULAR, ENCORE, SIZE45 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888912023436), received between Jul 29, 2017 and Sep 30, 2026 — classified as 12 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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available6
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated2
- Naturally Worn1
- Unstable1
Patient problems
- Unspecified Infection4
- Joint Dislocation3
- Pain2
- Arthritis1
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50941458 ↗InjuryJul 27, 2026Device Dislodged or Dislocated
InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: HEMI TO TOTAL HIP CONVERSION, DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25010679 ↗InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 5, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14921107 ↗InjuryAug 3, 2021Appropriate Device Problem Term/Code Not Available
InjuryJun 18, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - LATE INFECTION OF PREVIOUS BIPOLAR HIP SURGERY. PATIENT WAS TAKEN TO SURGERY AND FEMORAL HEAD AND BIPOLAR COMPONENT WERE REMOVED, IRRIGATION AND DEBRIDEMENT PERFORMED AND SAME SIZE COMPONENTS WERE OPENED AND IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 12028689 ↗InjuryOct 1, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT'S HIP DISLOCATED. REMOVED THE BIPOLAR AND HEAD. CONVERTED TO A UNIPOLAR HIP.
Patient problems: Joint Dislocation
MAUDE report 9139328 ↗InjurySep 18, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENTS HIP DISLOCATED. REMOVED AND EXCHANGED OUT THE BIPOLAR AND HEAD.
Patient problems: Joint Dislocation
MAUDE report 9081377 ↗InjuryAug 23, 2019Appropriate Device Problem Term/Code Not Available
InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT DEVELOPING ARTHRITIS. THE SURGEON CONVERTED FROM A BIPOLAR TO A TOTAL.
Patient problems: Arthritis
MAUDE report 6993981 ↗InjuryJul 29, 2017Naturally Worn
REVISION SURGERY - THE PATIENT HAD HIP PAIN DUE TO ACETABULAR WEAR.
Patient problems: Pain
MAUDE report 6752967 ↗
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-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-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-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-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-0095-2008 · Aug 2, 2007 · TerminatedFoundation 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-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-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-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
- Z-0093-2008 · Aug 2, 2007 · TerminatedFoundation 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-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-0088-2008 · Aug 2, 2007 · TerminatedFoundation 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-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-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
…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.
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