PINNACLE 1217-11-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295009047), received between Jan 8, 2019 and Sep 8, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Device Dislodged or Dislocated

  It was reported the patient underwent a revision THR. The Poly Liner disengaged from the Shell and broke into a few pieces. The Cup and Implant Sector Shell were extracted and a new Poly Insert and Screw were added. The Stem was well fixed; the Taper was not damaged and a revision Delta TS Head was used.

  Patient problems: Insufficient Information

  MAUDE report 50670778 ↗
• InjuryJul 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body Reaction

  MAUDE report 19719862 ↗
• InjuryOct 18, 2023Use of Device Problem; Device Dislodged or Dislocated; Noise, Audible; Use of Device Problem; Device Dislodged or Dislocated; Noise, Audible

  CUP REVISION FOR PAIN AND SQUEAKING OF IMPLANT. ON X RAY, CUP APPEARS OPEN AND TOO ANTEVERTED. FOR OPEN ASSESSMENT OF CUP AND LINER. INTRAOPERATIVELY THE LINER WAS FOUND TO HAVE COMPLETELY MALFORMED AND CERAMIC HEAD HAS BEEN RUBBING AGAINST METAL SHELL. SHELL LEFT IN SITU DUE TO PATIENTS AGE AND BMI AND BONE LOSS - +4 10 DEGREE FACE CHANGING LINER INSERTED WITH 32 +1 REVISION HEAD. DOI: (B)(6) 2017. DOE: (B)(6) 2023. AFFECTED SIDE.

  Patient problems: Pain

  MAUDE report 17957760 ↗
• InjuryJul 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION HIP ON (B)(6) 2021, WHERE A PINNACLE ACETABULAR POLY LINER WAS COMPLETELY WORN AND DELAMINATED. PRIMARY SURGERY TOOK PLACE IN 2014 AT ANOTHER (B)(6) HOSPITAL, THE PINNACLE SHELL AND LINER WAS REVISED. THE PRIMARY FEMORAL STEM WAS A CORAIL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12218003 ↗
• InjuryJan 8, 2019Noise, Audible; Separation Problem; Noise, Audible; Separation Problem

  IT WAS REPORTED THAT PATIENT WAS PREVIOUSLY A REPEAT DISLOCATOR. AFTER CLOSE TO A YEAR OF NO REPEAT PROBLEMS, PATIENT NOTICED A SQUEAKING NOISE AND WAS X-RAYED. LOOKED AS THOUGH SHE HAD DISLOCATED AGAIN AND HEAD WAS RESTING ON LIP OF 10 "DEGRESS". LINER: DURING SURGERY IT WAS FOUND THAT THE LINER HAD FRACTURED IN TWO PIECES AND POSSIBLY HAD DISASSOCIATED FROM THE CUP WHILE IN PATIENT. NOTICED DAMAGE ON VARIOUS PARTS OF LINER, MARKS ON A HEAD FROM METAL ON CERAMIC ARTICULATION. CUP WAS WELL FIXED. PATIENT WAS REVISED TO LARGER CUP AND LARGER HEAD.

  Patient problems: No Code Available

  MAUDE report 8228976 ↗