PINNACLE 2218-36-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295101307), received between Apr 30, 2018 and Mar 10, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE IS REPORTED DUE TO WEAR AND TEAR OVER THE YEARS. IT DID NOT HAPPENED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560194 ↗
• MalfunctionSep 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NURSE TAGGED 36MM +4/10DEG POLY LINER TRIAL 60MM AS DAMAGED FOLLOWING TOTAL HIP REPLACEMENT. LOCKING CLIP THAT HOLDS SCREW OF LINER TRIAL WAS DISLODGED. PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692863 ↗
• MalfunctionSep 30, 2022Material Integrity Problem; Material Integrity Problem

  INFORMED BY ORTHOTECH OF DAMAGED INSTRUMENTS. SURGEON UNKNOWN. NO PATIENT CONSEQUENCES. IN NEED OF URGENT REPLACEMENT FOR BUSY HOSPITAL. ALL INSTRUMENTS ARE WASHED AND TAGGED AS DAMAGED. THEY ARE READY FOR COLLECTION TODAY FROM THE ORTHOTECH OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510472 ↗
• MalfunctionSep 1, 2021Break; Break

  IT WAS REPORTED THAT THE METAL SCREW PIECE ON THE 36X60MM +40 10 DEGREE LINER TRIAL CAME OFF AND WILL NOT REATTACH. THE ORANG LINER PIECE CAME OFF. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408447 ↗
• MalfunctionMar 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE MIDDLE METAL PIECE OF THE PINNACLE POLY LINER IS BENT AND NOT WORKING PROPERLY. THIS DID NOT HAPPEN IN SURGERY, THEREFORE DID NOT DELAY. NOBODY WAS INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516000 ↗
• MalfunctionOct 22, 2019Break; Component Missing; Scratched Material; Break; Component Missing; Scratched Material

  IT WAS REPORTED THAT THE LINER TRIALS SCREW TIP ENDS BOTH BROKE OFF DURING SURGERY. ONE PIECE BROKE OFF. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9220752 ↗
• MalfunctionJul 2, 2019Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT 2 BROKEN LINER TRIALS ( TIP SCREW BROKE) AND 1 BROKEN PINNACLE CUP HANDLE BROKE. THERE WAS SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 8755205 ↗
• 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 8736530 ↗
• MalfunctionOct 31, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026283 ↗
• MalfunctionOct 31, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026278 ↗
• MalfunctionOct 31, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026255 ↗
• MalfunctionOct 31, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026241 ↗
• MalfunctionApr 30, 2018Break; Break

  IT WAS REPORTED THAT THE TRIAL WAS FOUND BROKEN IN THE PAN BEFORE SURGERY. IT WAS NOT USED OR NEEDED DURING THE CASE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7471830 ↗