PINNACLE 2218-54-047Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295520566), received between Apr 8, 2021 and Aug 17, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50284640 ↗
• MalfunctionDec 24, 2025Crack; Crack

  IT WAS REPORTED THAT THE TRIAL CRACKED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888845 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT THE PINNACLE DM LINER BROKEN WHILE TRYING TO SECURE IT TO CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862551 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT THE LINER BROKE INTO TWO PIECES. ALL PIECES WERE RETRIEVED. THERE WAS NO ADVERSE EVENT OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778838 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LINER TRIAL WILL NOT STAY TOGETHER.

  Patient problems: Insufficient Information

  MAUDE report 22026091 ↗
• MalfunctionApr 17, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE EDGE OF THE TRIAL LINER CRACKED AND THE DUAL MOBILITY TRIAL WAS BROKEN INTO TWO PIECES. BOTH PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855021 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT THE LINER TRIAL BROKE WHEN SURGEON WAS SCREWING THE TRIAL INTO THE CUP. A SECOND TRAY WAS OPENED AND A SECOND TRIAL WAS USED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676708 ↗
• MalfunctionJan 23, 2025Break; Break

  IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21219572 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT CENTRAL STERILE STAFF IDENTIFIED FEMORAL HEAD IMPACTORS WITH DAMAGED TIPS, FEMORAL CANAL PROBE WITH DAMAGED FLUTES WITH THE POTENTIAL TO PRODUCE METAL BURRS, AND PLASTIC TRIAL COMPONENTS WITH DEEP GROOVES AND DAMAGE. THIS DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20550042 ↗
• MalfunctionOct 23, 2024Crack; Crack

  IT WAS REPORTED THAT THE LINER TRIAL CRACKED UPON REMOVAL, ALL PIECES WERE ACCOUNTED FOR. TRIAL WAS DISCARDED BY THE SURGEON. NO CASE DELAY OR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517664 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT THE 54 DM LINER TRIAL WAS BROKEN. BOTH PIECES ARE ACCOUNTED FOR AND WILL BE RETURNED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063260 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE IN WASHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504574 ↗
• MalfunctionFeb 29, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809060 ↗
• MalfunctionJan 8, 2024Crack; Crack

  IT WAS REPORTED THAT DM LINER TRIAL CRACKED. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466325 ↗
• MalfunctionJun 2, 2023Break; Break

  IT WAS REPORTED THAT THE LINER BROKE AT THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052173 ↗
• MalfunctionApr 11, 2023Break; Break

  IT WAS REPORTED THAT THE ATTACHMENT PIECE BROKE OFF WHEN REMOVING LINER. NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716076 ↗
• MalfunctionNov 23, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LINER BENT AS THE SURGEON WAS REDUCING THE HEAD INTO THE LINER/CUP. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851053 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED THAT THE PINNACLE DUAL MOBILITY LINER TRIAL BROKEN DURING TRIAL REDUCTION. A SMALL PIECE OF THE LIP OF OF THE LINER BROKE OFF. THERE WAS A SURGICAL DELAY OF 45 MINUTES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15843632 ↗
• MalfunctionMar 8, 2022Break; Break

  THE TRIAL BROKE DURING CASE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691632 ↗
• MalfunctionOct 8, 2021Break; Break

  IT WAS REPORTED THAT WHILE REMOVING THE 54/47 PINNACLE DUAL MOBILITY CUP TRIAL, THE RIM CRACKED. ALL PIECES OF THE BROKEN TRIAL WERE IDENTIFIED BY THE SURGEON AND RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599039 ↗
• MalfunctionApr 8, 2021Break; Break

  IT WAS REPORTED THAT THE PLASTIC ON TRIAL CRACKED IN SURGERY. THE PIECE OF PLASTIC BROKE OFF IN THE WASHER AFTER THE CASE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11637213 ↗