PINNACLE 2218-28-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295100188), received between Oct 19, 2017 and May 13, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT THE TRIAL LINER SCREW WAS BROKEN OFF FROM THE PLASTIC TRIAL. ALL PIECES WERE RETRIEVED. THERE WAS NO DELAY AND NO HARM TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159586 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON SHEARED OFF EDGE OF LINER TRIAL DURING EXPLANT. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21922339 ↗
• MalfunctionMar 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING CLIP THAT HOLDS THE METAL PART TO THE PLASTIC LINER BROKE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538979 ↗
• MalfunctionJun 8, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LINER IS DAMAGED DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14631871 ↗
• MalfunctionJan 25, 2022Break; Break

  IT WAS REPORTED THAT THE PIECE OF THE TRIAL LINER BROKE OFF FOR UNKNOWN REASON. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342395 ↗
• MalfunctionJan 24, 2022Naturally Worn; Naturally Worn

  PARTS ARE STRIPPED AND WOULD NOT SCREW TOGETHER. NO FRAGMENTS PRODUCED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338557 ↗
• MalfunctionJan 24, 2022Naturally Worn; Naturally Worn

  PARTS ARE STRIPPED AND WOULD NOT SCREW TOGETHER. NO FRAGMENTS PRODUCED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338546 ↗
• MalfunctionMay 13, 2020Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  DURING THE COVID PERIOD, HOSPITAL STAFF AT (B)(6) EXAMINED A VARIETY OF SETS AND CAME ACROSS SEVERAL DAMAGED INSTRUMENTS (7 TOTAL) IN THEIR PINNACLE BANTAM SET THAT REQUIRE REPLACING: THE PINNACLE IMPACTOR ADAPTER AND SHELL TRIAL WERE CROSS THREADED AND NO LONGER USABLE (221750048 & 221701038). THE 28MM LINER IMPACTOR WAS GAUGED (221750006). THE ARTICULEZE TRIAL BALLS AND NEUTRAL TRIAL LINERS WERE ALSO GAUGED AND NOT USABLE DUE TO WEAR AND TEAR (253070000, 253069000, 221828044 & 221828046). ALL ITEMS WERE DISCARDED. NO PATIENT OR INTRA-OP ISSUES AS THIS DID NOT OCCUR IN THE OR. PLEASE SEND REPLACEMENTS TO THE FOLLOWING ADDRESS: (B)(6). BILL TO: (B)(4). SHIP TO: (B)(4). N/C PO TO FOLLOW. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION). REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: ONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053521 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT THE SCREW TIPS WAS BROKE OFF TWO POLY TRIALS. BOTH PIECES RETRIEVED. THEY WERE DISCARDED BY HOSPITAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290648 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT THE SCREW TIPS WAS BROKE OFF TWO POLY TRIALS. BOTH PIECES RETRIEVED. THEY WERE DISCARDED BY HOSPITAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290602 ↗
• InjuryOct 19, 2017Break; Break

  IT WAS REPORTED THAT THE PINNACLE LINER TRIAL SCREW TIPS BROKE OFF DURING SURGERY. DISCARDED BY THE HOSPITAL.

  Patient problems: No Information

  MAUDE report 6961382 ↗