Logical 111-12-9135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09348215001292), received between Jun 21, 2019 and Jun 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K121297); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MIDDLE HOLE IS WHERE DR. (B)(6) SCREWED THE 35 MM SCREW INTO THE BONE. THE SCREW WENT THROUGH THE HOLE AND WAS ALL THE IN THE BONE. HE THEN GOT THE SCREW AND SHELL OUT SUCCESSFULLY. HE ASKED FOR A NEW 48 SHELL. I GAVE HIM A NEW ONE HOWEVER HE SAYS THE SHELL OUTER PART WASN'T STICKING WELL TO THE BONE. SO WE DECIDED TO GO UP TO A 50. I PUT THE SCREW AND SHELL IN ONE BAG AND THE OTHER SHELL IN WHICH IT WASN'T ATTACHING TO THE BONE IN THE OTHER. A REPLACEMENT CUP SIZE 50 WAS USED AND WAS SUCCESSFUL.

  Patient problems: Failure of Implant

  MAUDE report 8721033 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121297. One submission often covers many models, so check the product and lot details in each record.

• Z-1694-2021 · Apr 20, 2021 · Terminated
  Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
• Z-0920-2018 · Feb 2, 2018 · Terminated
  Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads