DJO SURGICAL 497-28-700Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, COCR 28/+7MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912087292), received between Aug 10, 2017 and Jul 29, 2026 — classified as 16 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).
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 Problem10
- Device Dislodged or Dislocated5
- Appropriate Device Problem Term/Code Not Available1
- Inadequacy of Device Shape and/or Size1
- Unstable1
Patient problems
- Joint Dislocation7
- No Known Impact Or Consequence To Patient3
- Implant Pain2
- Failure of Implant1
- Joint Laxity1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 30, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 8, 2023Adverse 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
InjuryFeb 6, 2020Device Dislodged or Dislocated
REVISION SURGERY: DUE TO CHRONIC HIP DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9678455 ↗InjuryNov 1, 2019Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9269207 ↗InjuryAug 1, 2019Device Dislodged or Dislocated
REVISION SURGERY -PATIENT HAS DISLOCATION SO SURGEON PUT IN A LOCKING LINER AND CHANGE HEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8853199 ↗InjuryJan 16, 2019Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Failure of Implant
MAUDE report 8254774 ↗InjurySep 12, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT'S HIP DISLOCATING.
Patient problems: Joint Dislocation
MAUDE report 7870630 ↗InjuryAug 10, 2017Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated
REVISION SURGERY - THE NECK LENGTH ON THE ORIGINAL HEAD WAS NOT LONG ENOUGH AND KEPT DISLOCATING. THE SURGEON NEEDED TO IMPLANT A 10 DEGREE HOODED LINER TO PREVENT FURTHER DISLOCATING. THIS REVISION FOR THE LEFT HIP.
Patient problems: No Code Available
MAUDE report 6785768 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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