PINNACLE 2218-10-054Recalls & reported problems
Depuy (Ireland) · PINNACLE CERAMIC LINER INSERTER GRIPPER 54mm · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295457220), received between Oct 2, 2023 and Dec 4, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2024Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE LOAN KIT WAS RECEIVED WITH A PINNACLE INSERTER BROKEN. THIS DID NOT INTERFERE WITH THE SURGERY. THE COTYL IMPLANTED WAS NOT A 54 SIZE. THERE WAS NO IMMEDIATE PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20846043 ↗MalfunctionOct 2, 2023Break; Break
CERAMIC INSERTER BROKEN SNAPPED IN TWO. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17850423 ↗
Other PUSHER, SOCKET devices
- NA 2299-90-025Depuy Orthopaedics, Inc. · PUSHER, SOCKET9 reports
- NA 2299-90-030Depuy Orthopaedics, Inc. · PUSHER, SOCKET5 reports
- PINNACLE 2218-10-058Depuy (Ireland) · PUSHER, SOCKET1 report
- PINNACLE 2218-10-056Depuy (Ireland) · PUSHER, SOCKET1 report
- FIREBIRD SFS 51-7111Orthofix US LLC · PUSHER, SOCKET1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.