MICROPORT PHA04436Recalls & reported problems
Microport Orthopedics Inc. · Class 2 · Implant
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 M684PHA044361), received between Nov 21, 2019 and Mar 9, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
Patient problems
- No Information1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, LEFT HIP PERIPROSTHETIC INFECTION, PAIN. IRRIGATION AND DEBRIDEMENT WITH HEAD AND LINER EXCHANGE.
Patient problems: Pain; Unspecified Infection
MAUDE report 16518329 ↗InjuryNov 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE DOCTOR PULLED THE NECK, HEAD, SLEEVE, LINER, AND 3 SCREWS AND CEMENTED IN A BIOMET CONSTRAINED LINER. THE PATIENT HAD A PREVIOUS REVISION FOR MOM, INCIDENT GROUP 19060012, A SECOND REVISION FOR INFECTION, INCIDENT GROUP 19060187, AND A THIRD REVISION FOR DISLOCATION, INCIDENT GROUP 19060015 ITEMS NOT REVISED: DYNASTY BIOFOAM SHELL DSBFGG60 LOT 079859623, PROFEMUR PLASMA Z STEM PHA00270 LOT 067445032.
Patient problems: No Information
MAUDE report 9358640 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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