Patient Matched Implants CP161947Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304532403), received between Jan 9, 2026 and Jan 9, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 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.

• 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 24020711 ↗
• 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 24020689 ↗

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. Rheu
• 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