DJO SURGICAL 497-28-105Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, COCR 28/+10.5MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912087285), received between Dec 16, 2016 and Jun 5, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Problem9
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated3
- Unstable2
- Detachment of Device or Device Component1
- Patient Device Interaction Problem1
Patient problems
- Joint Dislocation7
- Unspecified Infection4
- Failure of Implant3
- Discomfort1
- Joint Laxity1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 2, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
FAILED CONSTRAINED LINER. USED DEPUY W/ENOVIS.
Patient problems: Failure of Implant
MAUDE report 23824455 ↗InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 13, 2024Unstable; Unstable
REVISION SURGERY DUE TO CHRONIC DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 20931978 ↗InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem
InjuryMar 22, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - PATIENT DISLOCATED, NO TRAUMA.
Patient problems: Joint Dislocation
MAUDE report 11542908 ↗InjuryMay 6, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10029493 ↗InjuryJul 26, 2019Appropriate Device Problem Term/Code Not Available
2ND REVISION SURGERY - DUE TO POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8833345 ↗InjuryJun 18, 2019Detachment of Device or Device Component
REVISION SURGERY - DUE TO THE HEAD BALL HAVING COME LOOSE FROM THE TRUNNION.
Patient problems: Failure of Implant
MAUDE report 8709273 ↗InjurySep 22, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 6887726 ↗InjuryDec 16, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POOR POST-OPERATION TREATMENT/CARE; RESULTING IN AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6183402 ↗
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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