DJO SURGICAL 412-02-052Recalls & reported problems
Encore Medical, L.P. · SHELL, BIPOLAR, MODULAR, ENCORE, SIZE52 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888912077439), received between Sep 14, 2018 and May 21, 2026 — classified as 11 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
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available2
- Device Dislodged or Dislocated2
- Fracture1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection4
- No Code Available2
- Discomfort1
- Failure of Implant1
- Fall1
- Joint Dislocation1
- No Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 23, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO BIPOLAR SHELL CAME APART.
Patient problems: Failure of Implant
MAUDE report 24424090 ↗InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 21, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PATIENT HAD MILD INFECTION SYMPTOMS. AN IRRIGATION AND DRAINAGE WAS DONE.
Patient problems: Unspecified Infection
MAUDE report 15077250 ↗InjuryFeb 22, 2020Device Dislodged or Dislocated
REVISION SURGERY - HEAD AND BIPOLAR COMPONENT DISASSOCIATED CAUSING DISLOCATION.
Patient problems: No Code Available
MAUDE report 9742687 ↗InjuryDec 11, 2019Fracture; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATENT FELL AND FRACTURED AND THE PROSTHESIS CAME LOOSE.
Patient problems: Fall
MAUDE report 9451190 ↗InjuryJul 11, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD AN IRRIGATION & DRAINAGE PROCEDURE WITH BIPOLAR HEAD SWAP DUE TO POSSIBLE INFECTION.
Patient problems: No Information
MAUDE report 8783207 ↗InjuryMay 14, 2019Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO THE PATIENT DISLOCATING. WAS NOT LATERALIZED ENOUGH.
Patient problems: No Code Available
MAUDE report 8609450 ↗InjurySep 14, 2018Insufficient Device Problem Information
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
…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