PINNACLE 2218-32-254Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295100935), received between Mar 12, 2018 and Oct 15, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Crack; Material Deformation; Scratched Material; Crack; Material Deformation; Scratched Material

  IT WAS REPORTED 3 INSTRUMENTS ARE CRACKED, BENT AND/OR SCRATCHED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294369 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT WHILE IMPLANTING A 54ODX32ID LIPPED TRIAL LINER, THE LINER FRACTURED AND BECAME UNUSABLE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940550 ↗
• MalfunctionMar 8, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  PINNACLE LINER TRIAL IS WORN AND SCRATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697075 ↗
• MalfunctionJan 28, 2021Break; Break

  LINER TRIAL DAMAGED AS SURGEON REMOVED COMPONENT FROM PATIENT. ALL FRAGMENTS COLLECTED AND SURGERY CONTINUED WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11247410 ↗
• MalfunctionMar 12, 2018Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  TOTAL HIP REPLACEMENT - DAA - DR (B)(6), (B)(6) HOSPITAL. DR (B)(6) WAS HAVING DIFFICULTY IN BEING ABLE TO SEE THE MARKINGS ON THE TRIAL LINER DUE TO BEING HEAVILY SCRATCHED AS WELL AS BEING FADED. THE GRUB SCREW ALSO FELL OUT WHEN REMOVING THE LINER FROM THE PATIENT REQUIRING THE SURGEON TO GET AN ADDITIONAL INSTRUMENT TO FIND AND RETRIEVE THE SCREW. ACTION TAKEN: OPEN THE SECOND SET OF TRIAL LINERS WHICH WERE AVAILABLE. NO DELAY TO PROCEDURE. NO AE TO PATIENT. MALE PATIENT INITIALS (B)(6).N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7331338 ↗