Profemur PHAC1234Recalls & reported problems
Microport Orthopedics Inc. · PROFEMUR® PLUS NECK A/R 8DG LONG COBALT CHROME · Class 2 · Implant
All models of PROFEMUR (116)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00192629087323), received between Jul 28, 2026 and Jul 29, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Insufficient Device Problem Information
Allegedly, patient was revised due to Infection.SRNJR Number: (b)(4).Side: L.Gender: F.Non-MPO products related:Product ID: 321.03.052 TRINITY NO HOLE SHELL 052MM TAPER SIZE 3.Product ID: 321.03.052 TRINITY ECIMA LINER SIZE 3 36MM NEUTRAL 4MM EPW.
Patient problems: Unspecified Infection
MAUDE report 50064297 ↗InjuryJul 28, 2026Break
Allegedly, patient was revised due to Implant Fracture of a nonceramic component - Stem. SRNJR Number: (b)(6).Side: L.Gender: M. Non revised MPO products:Product ID: PHA06264 PROCOTYL L ACETABULAR CUP BEADED COATED + HA 54 GROUP E/ Lot No.: 1530805/ QTY: 1.Product ID: PHA04510 RIMLOCK BIOLOX DELTA CERAMIC LINER 36 GROUP E/ Lot No.: 1476911/ QTY: 1.
Patient problems: Insufficient Information
MAUDE report 50048377 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices
- Accolade 6021-0537Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
- PROFEMUR® PHAC1252Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous37 reports
- Accolade 6020-0335Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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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