MICROPORT PHA04413Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684PHA044131), received between Oct 12, 2021 and Nov 19, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION COMPONENTS NOT REVISED: PRODUCT: PRODUCT ID: LOT#: PROCOTYL L BEADED AND HA COATED CUP SIZE 54MM: PHA06264, 1731318; RIM-LOCK A-CLASS CROSS-LINKED POLYETHYLENE LINERS 15 DEG 32MM ID GROUP E: PHA04660, 1857529; PROFEMUR TL STEM SIZE 5: PRTL0025, 1867002; PROFEMUR® NECK 8DG A/R SHORT: PHA01232, 1856496. (B)(4). SIDE:R PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12843992 ↗
• InjuryOct 12, 2021Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  ALLEGEDLY, THE PATIENT DISLOCATED A FEW DAYS AFTER THE ORIGINAL SURGERY, THIS WAS REDUCED AND THE PATIENT WAS OK FOR ABOUT 10 DAYS. BEFORE THERE WAS A FURTHER DISLOCATION. THE SURGEON FELT THAT THE REASON FOR THE DISLOCATION WAS A LACK OF TENSION, OR OFFSET. THIS WAS RESOLVED WITH A LONGER NECK, CREATING MORE OFFSET. THE OPERATION WAS COMPLETED SUCCESSFULLY, THE PATIENT HAS SINCE BEEN DISCHARGED FROM HOSPITAL. THE SURGEON PUTS THIS DOWN TO SURGEON ERROR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12615301 ↗