DJO SURGICAL 412-02-044Recalls & reported problems
Encore Medical, L.P. · SHELL, BIPOLAR, MODULAR, ENCORE, SIZE44 · 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 00888912077361), received between Dec 16, 2015 and Sep 4, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated1
Patient problems
- Unspecified Infection5
- Fall1
- Hip Fracture1
- Implant Pain1
- No Code Available1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 3, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT GOT INFECTED AFTER SURGERY. DID AN IRRIGATION AND DRAINAGE CHANGING OUT THE BI-POLAR AND METAL HEAD.
Patient problems: Unspecified Infection
MAUDE report 14598598 ↗InjuryDec 21, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND FRACTURED HIP.
Patient problems: Fall; Hip Fracture
MAUDE report 13052698 ↗InjuryAug 27, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT DEVELOPING AN INFECTION, SURGEON REMOVED ALL IMPLANTS AND REVISED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 8937231 ↗InjuryDec 16, 2015Device Dislodged or Dislocated
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
…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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