Patient Matched Implants CP161949Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304546028), received between Mar 21, 2023 and Jan 9, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K991807); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE LOSS WITH IMPLANT MIGRATION AND LOOSENING. SUBSEQUENTLY, A REVISION PROCEDURE IS PENDING. IT WAS NOTED THAT THE PATIENT HAS A HIGHER BODY WEIGHT (REPORTED TO BE 300+). A NEW TRIFLANGE IMPLANT IS CURRENTLY IN PROCESS WITH THE MANUFACTURER, AND A REVISION DATE HAS NOT YET BEEN SCHEDULED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Osteopenia/ Osteoporosis

  MAUDE report 24020752 ↗
• InjuryNov 12, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT HIP REVISION. THE PATIENT FELL AND DISASSOCIATED THE IMPLANT FROM THE PELVIS. THE TRIFLANGE SCREWS HAD STARTED TO RIP OUT FROM THE PELVIS FOLLOWING THE FALL. NO KNOWN REVISION HAS TAKEN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 23534826 ↗
• InjuryMar 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY DUE TO LEG LENGTH DISCREPANCY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unequal Limb Length

  MAUDE report 16582220 ↗
• InjuryMar 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY DUE TO LEG LENGTH DISCREPANCY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unequal Limb Length

  MAUDE report 16582208 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991807. One submission often covers many models, so check the product and lot details in each record.

• Z-0621-2021 · Nov 25, 2020 · Terminated
  Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheum
• Z-2135-2011 · Mar 10, 2011 · Terminated
  Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE. To provide fixation of any acetab