DJO SURGICAL 412-02-048Recalls & reported problems
Encore Medical, L.P. · SHELL, BIPOLAR, MODULAR, ENCORE, SIZE48 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912077392), received between Mar 3, 2016 and Jun 26, 2023 — classified as 14 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated4
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Fracture1
- Material Erosion1
- Unstable1
Patient problems
- Joint Laxity3
- No Code Available3
- Failure of Implant2
- Fall2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Joint Dislocation1
- Medical device site infection1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - FOUNDATION BIPOLAR WAS IMPLANTED. REVISION DUE TO SUPERIOR WEAR OF THE ACEATABULUM.
Patient problems: Joint Laxity
MAUDE report 15634085 ↗InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD SURGERY FOR A FRACTURED HIP USING A DJO BIPOLAR. THE PATIENT DEVELOPED A POST OPERATIVE INFECTION AND AN IRRIGATION AND DRAINAGE WAS PERFORMED. THE SURGEON REMOVED THE BIPOLAR MODULAR 48/28 AND THE 28MM FEMORAL HEAD AND REPLACED WITH THE SAME IMPLANTS.
Patient problems: Medical device site infection
MAUDE report 15303782 ↗InjuryJun 29, 2022Material Erosion
REVISION SURGERY - SURGEON STATED "EROSION OF THE ACETABULUM" AS THE REASON FOR CONVERSION FROM A BI-POLAR HEAD TO A TOTAL HIP. THE BI-POLAR HEAD APPEARED TO BE IN VERY GOOD CONDITION.
Patient problems: Failure of Implant
MAUDE report 14856595 ↗InjuryApr 21, 2022Unstable
InjuryOct 1, 2021Device Dislodged or Dislocated
REVISION SURGERY - PATIENT HAD RECURRENT DISLOCATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12561827 ↗InjuryAug 25, 2021Detachment of Device or Device Component
REVISION SURGERY - DUE TO DISASSOCIATION AFTER A FALL.
Patient problems: Failure of Implant; Fall
MAUDE report 12367342 ↗InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - WENT TO DO PRIMARY SURGERY, FOUND THE PATIENT HAD AN INFECTION. SURGEON OPTED TO PUT IN A BI-POLAR USING A LOT OF ANTIBIOTIC CEMENT TO HELP CLEAR THE INFECTION. ONCE THE INFECTION WAS CLEARED, PULLED ALL OUT AND PUT IN A TOTAL HIP.
Patient problems: Unspecified Infection
MAUDE report 11716486 ↗InjuryJul 31, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - CHRONIC DISLOCATION REMOVED BIPOLAR AND STEM AND CONVERTED TO TOTAL HIP.
Patient problems: Joint Dislocation
MAUDE report 10351072 ↗InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE BIPOLAR SHELL DISLOCATING FROM THE FEMUR HEAD.
Patient problems: No Code Available
MAUDE report 7005833 ↗InjuryJan 18, 2017Fracture
REVISION SURGERY - DUE TO THE PATIENT FALLING AND BREAKING THEIR HIP; THE SURGEON REPLACED WITH A LONGER STEM.
Patient problems: Fall
MAUDE report 6260801 ↗InjurySep 23, 2016Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT DISLOCATING.
Patient problems: No Code Available
MAUDE report 5975301 ↗InjuryMar 3, 2016Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE FREQUENT DISLOCATION OF THE BIPOLAR FEMORAL HEAD FROM THE ACETABULUM.
Patient problems: No Code Available
MAUDE report 5477623 ↗
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-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-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-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-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-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-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-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-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-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
- 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-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-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-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
…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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