PINNACLE 2218-58-049Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295520580), received between Jun 22, 2021 and Apr 29, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT THE PINNACLE DUAL MOBILITY TRIAL LINER BROKE MID-CASE AFTER SURGEON IMPACTED IT WITH MALLET INCORRECTLY (NOT INSTRUCTED TO, JUST HIS OWN WILL). THERE WERE NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031539 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT RING AROUND THE BOLT TO SCREW INTO THE CUP BROKE OFF. ALL PIECES RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567941 ↗
• MalfunctionFeb 10, 2026Crack

  IT WAS REPORTED THAT TRIAL LINER CRACKED DURING TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306083 ↗
• MalfunctionAug 28, 2024Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. PDM TRIAL IS BURNT FROM AUTOCLAVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091475 ↗
• MalfunctionNov 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SURGEON REMOVED THE C-RING THAT HOLDS THE SCREW IN THE D.M INSERT TRIAL. THE LINER AND SCREW WERE RECOVERED. THE C-RING WASN'T. LOOK AROUND THE FIELD AND MAYO STAND COULDN'T LOCATE IT. X RAY WAS DONE AND DIDN'T PRESENT A FOREIGN OBJECT.

  Patient problems: Insufficient Information

  MAUDE report 18085582 ↗
• MalfunctionOct 30, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN PUTTING THE TRAYS TOGETHER, THE CENTER SCREW FROM THE LINER POPPED OUT AND IT HIT THE FLOOR. IT WAS NOTICED THAT THE C-CLIP WAS MISSING. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034479 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION THA. LINER AND HEAD SWAP DUE TO METALLOSIS. REPLACED METAL ON METAL WITH A POLY LINER AND CERAMIC HEAD. ADDITIONALLY WHEN TRIALING DUAL MOBILITY OUR TRIALS SCREW RING BROKE OFF AND ARE IN NEED OF A REPLACEMENT. ALL PARTS WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770050 ↗
• MalfunctionAug 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PINNACLE DUAL MOBILITY TRIAL LINER 58 SCREW BROKEN OFF TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339261 ↗
• MalfunctionJun 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LOCKING RING TAB BECAME BEND AND MADE IT NOT BE ABLE TO BE USED. ALL PART RETRIEVED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041427 ↗