PINNACLE 2218-90-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295102304), received between Jan 26, 2018 and Apr 21, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE AB GRIPPER 56 HAD A LITTLE PIECE OF PLASTIC BROKEN OFF. UNABLE TO FIND BROKEN PIECES. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875039 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED THAT THE PINNACLE INSERT BROKE INTRAOPERATIVELY. MORE SPECIFICALLY, A TOOTH ON THE INSERT BROKE, SO THE CERAMIC INSERT IS NOT HOLDING WELL. THERE IS THEREFORE A RISK OF INCORRECTLY POSITIONING THE INSERT IN THE ACETABULUM PINNACLE IN VIVO INTRAOPERATIVELY. FRAGMENTS WERE EASILY REMOVED. SURGERY WAS DELAYED 10 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19466289 ↗
• MalfunctionJul 27, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn

  1.WHAT IS GO INVENTORY? A TOOL THAT ENABLES ME TO MANAGE REQUEST & VIEW BOTH PRODUCT & INVENTORY WITHIN MY ACCOUNTS & ACROSS THE DEPUY SYNTHES PRODUCT RANGE. 2. IF SHE WAS AWARE OF THE BROKEN INSTRUMENTS AT THE TIME THEY WERE ENTERED INTO "GO INVENTORY" IN THE MONTH OF (B)(6), OR IF A NON-J&J EMPLOYEE ENTERED THAT INFORMATION, AND THE SALES SPECIALIST BECAME AWARE OF THE PRODUCT MALFUNCTIONS ONLY LATER WHEN SHE SUBMITTED HER COMPLAINT INFORMATION ON (B)(6) 2021. I AM ASSUMING WHEN YOU USE THE TERM ¿SHE¿ YOU ARE REFERRING TO ME & NOT THE CUSTOMER? IF YOU ARE REFERRING IN THE CONTEXT TO ME I AM A ¿MALE¿ IT WAS REPORT DIRECTLY AFTER THE CUSTOMER REPORTED THE PRODUCT AS DAMAGED IN APRIL. THE COMPLAINT WAS NOT SUBMITTED ON THE (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231658 ↗
• MalfunctionJul 26, 2021Break; Material Twisted/Bent; Naturally Worn; Break; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN DUE TO HEAVY USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225690 ↗
• MalfunctionDec 2, 2019Break; Break

  THR : SMALL PIECE OF AB GRIPPER BROKE OFF, SMALL PIECE WAS RETRIEVED. NO DELAY TO SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9396652 ↗
• MalfunctionMay 11, 2018Crack; Crack

  YESTERDAY WE DISCOVERED THAT THE SIZE 56 PINNACLE GRIPPER WAS CRACKED AND PREVENTING INTRODUCTION DURING A PROCEDURE. COULD WE PLEASE GET A REPLACEMENT SENT IN. WE WEREN¿T SURE WHICH CODE ON THE GRIPPER WAS REQUIRED SO WE NOTED DOWN BOTH: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507588 ↗
• MalfunctionJan 26, 2018Break; Component Missing; Break; Component Missing

  SURGEON ADVISED ONE OF THE PLASTIC TEETH ON PINNACLE AB GRIPPER (SIZE 56) BROKEN REQUIRING REPLACEMENT. UNSURE WHEN THIS OCCURRED & UNABLE TO LOCATE PLASTIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7221037 ↗