NA 1018-36-503Recalls & reported problems
Depuy (Ireland) · M-SPEC METAL FEMORAL HEAD 14/16 TAPER Diameter 36mm +3 OFFSET · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295001379), received between Dec 13, 2017 and Dec 3, 2024 — classified as 4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Insufficient Device Problem Information1
Patient problems
- Joint Dislocation3
- No Code Available1
- Not Applicable1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGEON PUT IN A NEW CUP BECAUSE HE THOUGHT THE OLD CUP POSITION WAS CONTRIBUTING TO THE DISLOCATIONS.
Patient problems: Joint Dislocation
MAUDE report 20833749 ↗InjurySep 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING SO THE SURGEON WANTED TO REVISE ACETABULAR SIDE. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 10482985 ↗InjuryMay 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN ; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Not Applicable; Pain
MAUDE report 7479111 ↗InjuryDec 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. FEMORAL HEAD WAS REVISED.
Patient problems: Joint Dislocation
MAUDE report 7114187 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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