PINNACLE 2218-36-156Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295101284), received between Aug 16, 2017 and Mar 10, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 23 most recent of 23 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 24560198 ↗
• MalfunctionMar 2, 2026Scratched Material

  IT WAS REPORTED THAT A 36 X 56 +4/10 DEG LINER TRIAL IS DAMAGED. THERE WAS A LARGER SCRATCH IN THE LINER TRIAL AND THEREFORE COMPROMISING STERILITY. THERE WAS NO PATIENT INVOLVEMENT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484852 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT THE LINER TRIAL SCREW TIP BROKE OFF DURING SURGERY. IT WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777158 ↗
• MalfunctionMay 31, 2023Break; Break

  DEVICE WAS REPORTED FOR UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 17031470 ↗
• MalfunctionApr 3, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT INSTRUMENTS DAMAGED DURING STERILIZATION. ALL OF THE POLYS ARE SCRATCHED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663920 ↗
• MalfunctionMar 23, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT CENTRAL STERILE HAS BROUGHT TO SALES REPRESENTATIVE ATTENTION SOME INSTRUMENTS THAT ARE BROKEN. THESE INSTRUMENTS WERE NOT INVOLVED IN A SURGERY, THEY WERE NOTICED DURING ASSEMBLY AND INSPECTION. THE FEMORAL TRIAL HAS CRACK AT NOTCH, THE PINNACLE POLY LINER TRIALS, ONE IS DISCOLORED, THE OTHER HAS SHARP EDGES AROUND EDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598787 ↗
• MalfunctionOct 7, 2022Crack; Crack

  IT WAS REPORTED THAT THE TRIAL LINE IS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15562662 ↗
• MalfunctionAug 26, 2021Scratched Material; Scratched Material

  HANDED A PINNACLE 56/36 +4/10 DEGREE LINER TRIAL FROM CSSD MANAGER. THE LINER TRIAL HAS INCURRED DAMAGE IN THE WAY OF DEEP SCRATCHES TO THE OUTER BODY OF THE LINER TRIAL RENDERING IT UNABLE TO BE STERILIZED AS CSSD CANT ASCERTAIN IF ANY DEBRIS REMAINS INSIDE THE DEEP SCRATCHES. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED HOWEVER HAS BEEN FOUND ON INSPECTION BY CSSD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12373685 ↗
• MalfunctionApr 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE CASE THE SURGEON SAID THE SCREWDRIVER SHANK WAS STRIPPED AND THE SCREW WOULDN¿T FIT ON IT AND THE TRIAL LINER WOULDN¿T FULLY SEAT TO THE CUP. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670826 ↗
• MalfunctionJun 22, 2020Break; Break

  LINER TRIAL RING BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10181176 ↗
• MalfunctionMar 3, 2020Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  A RECURRING ISSUE WITH DIFFICULT CUP POSITION CASES ISSUES SCREWING LINERS INTO THE ACETABULAR CUP. WHEN USING THE SCREWDRIVER, THE LINER CENTRAL SCREW MECHANISM ANGLES AND EVENTUALLY DISASSOCIATES THE LOCKING RING FROM THE TRIAL. SURGICAL DELAY OF 5 MINUTES.

  Patient problems: No Code Available

  MAUDE report 9781883 ↗
• MalfunctionMar 3, 2020Break; Material Deformation; Break; Material Deformation

  A RECURRING ISSUE WITH DIFFICULT CUP POSITION CASES ISSUES SCREWING LINERS INTO THE ACETABULAR CUP. WHEN USING THE SCREWDRIVER, THE LINER CENTRAL SCREW MECHANISM ANGLES AND EVENTUALLY DISASSOCIATES THE LOCKING RING FROM THE TRIAL. SURGICAL DELAY OF 5 MINUTES.

  Patient problems: No Code Available

  MAUDE report 9781882 ↗
• MalfunctionSep 24, 2019Break; Material Disintegration; Material Twisted/Bent; Scratched Material; Break; Material Disintegration; Material Twisted/Bent; Scratched Material

  ADDITIONAL INFORMATION RECEIVED THAT THE RING BENT AND CAME OFF BUT DID NOT BREAK IN PIECES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112320 ↗
• MalfunctionSep 24, 2019Break; Material Disintegration; Material Twisted/Bent; Scratched Material; Break; Material Disintegration; Material Twisted/Bent; Scratched Material

  ADDITIONAL INFORMATION RECEIVED THAT THE RING BENT AND CAME OFF BUT DID NOT BREAK IN PIECES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112317 ↗
• 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 8736523 ↗
• 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 8026201 ↗
• 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 8026196 ↗
• MalfunctionOct 30, 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 8021612 ↗
• MalfunctionOct 30, 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 8021580 ↗
• MalfunctionJan 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SCREW OF +4N + 36X56 TRIAL WILL NOT TIGHTEN INTO THE CUP FOR TRAILING AND THE BUSHING RING OF +4 10 DEGREE X 56X36 TRIAL HAS BENT AND LOOSE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175266 ↗
• MalfunctionNov 7, 2017Break; Break

  IT WAS REPORTED THE LINER TRIAL HAS ETCH MARKINGS IN SURFACE, CSD WILL NOT ACCEPT. NOVEMBER 3, 2017 - REVIEW OF THE TRIAL LINER PHOTOGRAPHS FOUND DEEP GOUGES, NICKS, AND SCRATCHES WITH PIECES OF MATERIALS MISSING. (B)(6).

  Patient problems: No Information

  MAUDE report 7007110 ↗
• MalfunctionSep 8, 2017Break; Break

  IT WAS ALSO REPORTED THAT UPON REMOVING THE TRIAL LINER, IT WAS NOTED TO BE CRACKED AND THE TRIAL LINER SCREW DISENGAGED FROM THE LINER.

  Patient problems: No Information

  MAUDE report 6853033 ↗
• MalfunctionAug 16, 2017Break; Break

  IT WAS REPORTED THAT THE CENTRE OF TRIAL LINER BROKE.

  Patient problems: No Information

  MAUDE report 6796967 ↗