PINNACLE 2218-36-464Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295101413), received between Jun 26, 2019 and Oct 11, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CENTER PART OF LINER TRIAL IS STRIPPED AND NOT USEABLE. EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911643 ↗
• MalfunctionOct 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597458 ↗
• MalfunctionOct 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597447 ↗
• MalfunctionOct 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597445 ↗
• MalfunctionOct 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597440 ↗
• MalfunctionOct 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS 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 15597436 ↗
• MalfunctionAug 17, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A LOANER SET OF INSTRUMENTS WAS RECEIVED BACK FROM A HOSPITAL THAT CONTAINED RESIDUAL DEBRIS AND HAD TO BE RETURNED TO THE SITE FOR ADDITIONAL CLEANING BY THEIR STERILE PROCESSING DEPARTMENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10417498 ↗
• MalfunctionJun 26, 2019Material Discolored; Naturally Worn; Scratched Material; Material Discolored; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE LINERS ARE TOO WORN OUT TO BE USED IN SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736449 ↗