PINNACLE 2218-32-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295100836), received between Oct 30, 2017 and Apr 27, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Break

  DURING THE PROCEDURE WHEN REMOVING THE TEST INSERT TO PLACE THE FINAL INSERT, THE DEVICE BROKE WHEN SCREWING FROM THE CUP. IT WAS LEFT ON THE COMPUTER WITH RED RIBBON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997878 ↗
• MalfunctionFeb 11, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THA. AFTER THE SURGERY ON (B)(6) 2026, REVISION THA WAS PERFORMED FOR UNKNOWN REASON WITH THE DRILL SHAFT IN QUESTION. DURING THE SURGERY, THE PRODUCT WAS PARTIALLY BROKEN WHILE INSERTING IT AND ADJUSTING ITS ORIENTATION USING AN IMPACTION DEVICE OR SIMILAR INSTRUMENTS ON THE PINNACLE CUP WHICH WAS IMPLANTED IN THE PRIMARY OPERATION BECAUSE THE DRILL SHAFT COULD NOT INSERT SMOOTHLY. THE DRILL SHAFT OF SLIDING SURFACE WAS CHIPPED, AND THE C-RING HAS COME OFF. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE REVISION SURGERY. THIS PC REPORTS THE EVENT OCCURRED DURING THE REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313890 ↗
• MalfunctionDec 3, 2020Break; Break

  WHILE SCREWING THE PINNACLE POLY INTO THE CUP FOR TRIALS, THE SURGEON NOTICED THAT THE SCREW CAME OFF THE POLY TRIAL. IT SEEMS THAT THE LITTLE HORSESHOE TYPE RING HOLDING THE SCREW CAME OFF. THE SURGEON DID REMOVE THE PART FROM THE BOTTOM OF THE CUP. NO PATIENT HARM, NO DELAY OTHER THAN 2 MINUTES TO REMOVE THE PART. BOTH THE SCREW AND HORSESHOE PIN WERE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 10938277 ↗
• 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 8025502 ↗
• 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 8025479 ↗
• 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 8020721 ↗
• 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 8020704 ↗
• MalfunctionJan 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  (B)(6) HOSPITAL, (B)(6) 2017. PINNACLE TRIAL LINER 32 +4/10DEG 52MM. CONSIGNMENT INSTRUMENT AT GPH, IN A DAMAGED CONDITION. PHOTO INDICATED BURRS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171628 ↗
• MalfunctionDec 28, 2017Break; Break

  THA C STEM PINNACLE WHILE REMOVING THE TRIAL INSERT, THE SCREW THREAD FELL APART. ALL PARTS WERE REMOVED FROM THE CUP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7150543 ↗
• MalfunctionOct 30, 2017Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT UPON POST-SURGICAL EVALUATION OF IMPLANTS, THE CUP LINER WAS FOUND TO HAVE HEAVY SCARRING AND GAUGES.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6989511 ↗