PROFEMUR® PHAC1214Recalls & reported problems
Microport Orthopedics Inc. · PROFEMUR® NECK A/R VAR/VAL 2 LONG COBALT CHROME · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684PHAC12141), received between Feb 20, 2020 and Feb 28, 2024 — classified as 6 injuries.
The most frequently reported specific device problem is “Corroded” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Corroded4
- Insufficient Device Problem Information2
- Material Disintegration1
Patient problems
- Pain3
- Unspecified Infection2
- No Known Impact Or Consequence To Patient1
- Reaction1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, INFECTION SIDE: L REVISION NJR: (B)(4). GENDER: M EXPLANTED: FEMORAL STEM, ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER
Patient problems: Unspecified Infection
MAUDE report 18798368 ↗InjuryFeb 7, 2022Corroded; Corroded
ALLEGEDLY, THE PATIENT WAS REVISED DUE TO CORROSION OF THE MODULAR NECK AND PAIN(LEFT HIP).
Patient problems: Pain
MAUDE report 13470311 ↗InjuryApr 21, 2021Corroded; Corroded
ALLEGEDLY, PATIENT EXPERIENCED PAIN DUE TO CORROSION AT THE COCR MODULAR NECK.
Patient problems: Pain
MAUDE report 11703685 ↗InjurySep 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO DEEP WOUND INFECTION. LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 10503134 ↗InjuryAug 13, 2020Corroded; Corroded
ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION AT THE NECK-STEM JUNCTION OF THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10401964 ↗InjuryFeb 20, 2020Corroded; Material Disintegration; Corroded; Material Disintegration
ALLEGEDLY, PATIENT PRESENTED ELEVATED COBALT ION LEVELS AND PAIN. THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION OF THE DEVICE, CORROSION ON THE OBLONG TAPER WHERE THE NECK WAS SEATED IN THE POCKET OF THE PROFEMUR TITANIUM STEM, WHICH CAUSED ADDUCTOR DAMAGE, SOFT TISSUE REACTION AND PSEUDOTUMOR REACTION. DURING THE REVISION THE SURGEON REMOVED THE FAILED COMPONENTS OF THE PROFEMUR TOTAL HIP SYSTEM.
Patient problems: Pain; Reaction
MAUDE report 9733174 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.