PINNACLE 2218-36-158Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295101291), received between Jun 26, 2018 and Oct 19, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT SURGEON TRIALED THE LINER (36X58 +4/10D) AND NOTICED THAT THE MARKING THAT'S SUPPOSED TO BE ON THE HIGH EDGE OF THE LIP WAS MISSING/SCRATCHED OFF. HE REQUESTED A REPLACEMENT SO HE CAN PROPERLY TRIAL THE LINER. IT DID NOT IMPACT PATIENT OUTCOME. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966106 ↗
• MalfunctionJun 19, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158333 ↗
• MalfunctionApr 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE INSERTING THE SIZE 58 TRIAL LINER WHEN HE NOTICED THAT THE SCREW PART WAS LOOSE. UPON REMOVING THE LINER FROM THE PATIENT, THE SCREW PORTION WAS ACTUALLY SEPARATED FROM THE LINER ITSELF. DURING THE SAME SURGERY, THE SCRUB TECHNICIAN NOTICED THAT THE "LEVER" ON THE BROACH HANDLE WAS LOOSE, AND THE HANDLE WAS NOT HOLDING THE FEMORAL BROACH TOO WELL. THERE WERE NO ISSUES OR COMPLICATIONS, NO BROKEN PIECES WERE LEFT IN THE PATIENT AND SURGERY WAS SUCCESSFULLY COMPLETED. WE DO NOT HAVE EITHER OF THE INSTRUMENTS' LOT NUMBER, NOR BATCH, NOR SERIAL NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218998 ↗
• MalfunctionNov 26, 2019Scratched Material; Scratched Material

  PINNACLE LINER TRIALS HAVE SCRATCHES ON THE LINER EDGES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9375901 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED THAT THE TRIAL LINER BROKE DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813240 ↗
• MalfunctionJul 22, 2019Break; Break

  ADDITIONAL INFORMATION RECEIVED THAT PART OF THE TRIAL LINER BROKE WAS HE THREAD THAT SCREWS INTO THE POLAR HOLE OF THE CUP POKED THROUGH THE TRIAL. HE HAD THE SCREWDRIVER IN THE HEX AND WAS TRYING TO ENGAGE THE LINER TRIAL INTO THE PINNACLE SHELL. THE PLASTIC GAVE WAY AND THE THREAD WAS NOT IN THE LINER TRIAL. IT DID BREAK INTO 2 PIECES AND ALL PIECES OF THE BROKEN INSTRUMENT WAS RETRIEVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812818 ↗
• MalfunctionDec 18, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE LINER TRIAL DAMAGED TAKING OUT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8174839 ↗
• 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 8026232 ↗
• 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 8026226 ↗
• 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 8026221 ↗
• 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 8026219 ↗
• MalfunctionJun 26, 2018Break; Break

  IT WAS REPORTED THAT THE PINNACLE POLY TRIAL 36 X 58 + 4 DEGREE IS DAMAGED AND HAS SCRAPES ON IT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638105 ↗