PINNACLE 2218-32-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295100737), received between Aug 15, 2017 and Aug 14, 2026 — classified as 40 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261178 ↗
• MalfunctionMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT (THR) PROCEDURE THE LINER TRIAL WAS BROKEN AND THE SCREW AND SCREW HOLE WERE DAMAGED. IT WAS REPORTED THAT THE SCREW WOULD NO LONGER SIT IN THE BUILT-IN HOLE. IT WAS REPORTED THAT THERE WAS A 30-SECOND DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THE DAMAGED ITEM WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741181 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT WHILE PERFORMING A NEUTRAL LINER TRIAL, THE METAL SCREW BIT WITHIN THE MECHANISM BROKE INTO THREE PARTS: THE METAL ATTACHMENT, THE METAL RING, AND THE PLASTIC CUP. ALL PIECES WERE RETRIEVED. THE TRAIL WAS PART OF THE CONSIGNMENT PINNACLE NEUTRAL LINER TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259530 ↗
• MalfunctionJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CENTRAL METAL THREADING PIECE HAS FALLEN OUT OF THE PLASTIC TRIAL. ANOTHER TRAY WAS OPENED FOR THE PROCEDURE. THERE WAS A SURGICAL DELAY OF THREE MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298572 ↗
• MalfunctionJun 18, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED SEVERAL PINNACLE TRIALS LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR, AS WELL AS NO LONGER THREADING PROPERLY INTO THE TRIAL SHELL. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285276 ↗
• MalfunctionJun 17, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THE PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR; THEY ALSO NO LONGER THREAD PROPERLY INTO THE TRIAL SHELL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236282 ↗
• MalfunctionNov 6, 2023Scratched Material; Scratched Material

  LINER HAS BEEN DAMAGED WITH SCRATCHES AND GOUGES ON UNDERSIDE. UNABLE TO BE USED OPTIMALLY. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072822 ↗
• MalfunctionMay 31, 2023Break; Break

  DEVICE WAS REPORTED FOR UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 17031441 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087204 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087198 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087196 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087155 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087134 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087127 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087117 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087071 ↗
• MalfunctionDec 22, 2022Break; Break

  INFORMED BY HOSPITAL STAFF OF LINER BEING DAMAGED DURING CASE. NATURE OF DAMAGE- RIM OF LINER TRIAL CHIPPED. PART OF THEIR CONSIGNMENT SET, TRAY AND SERIAL NUMBER UNKNOWN. NO PATIENT CONSEQUENCES, CASE FINISHED SUCCESSFULLY WITH NO DELAY, NO DEBRIS. WASHED AND READY FOR COLLECTION. URGENT REPLACEMENT FOR TRAUMA HOSPITAL PLEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038020 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614752 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614709 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614692 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614626 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614502 ↗
• MalfunctionMar 15, 2022Naturally Worn; Naturally Worn

  INSTRUMENTS ARE TOO WORN TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771517 ↗
• MalfunctionNov 19, 2021Naturally Worn; Naturally Worn

  STAFF HAVE INDICATED A 32/54 LINER TRIAL WILL NO LONGER SCREW INTO THE TRIAL SHELL DURING SURGERY AS THE THREADS ARE STRIPPED. THIS INSTRUMENT REQUIRES REPLACEMENT AS IT IS NO LONGER USABLE DUE TO WEAR AND TEAR. THIS OCCURRED INTRA OP BUT SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAYS OR PATIENT ISSUES. NO FURTHER INFORMATION IS AVAILABLE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848128 ↗
• MalfunctionDec 14, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT INSTRUMENTS WERE FOUND IN THE STERILE PROCESSING DEPARTMENT AND HAVE GOUGES AND SCRATCHES ON THEM. STERILE PROCESSING DEPARTMENT SAID THE INSTRUMENTS NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11004689 ↗