PINNACLE 1217-11-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295009108), received between Aug 23, 2017 and Feb 26, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED ANTERIORLY TWICE. IT WAS THEN DETERMINED THAT THE CUP WAS TOO ANTEVERTED. SO THE SURGEON DECIDED TO REMOVE THE CUP AND REVISE TO A DUAL MOBILITY CONSTRUCT. THE LINER AND HOLE ELIMINATOR WERE REVISED AS WELL. DOI: (B)(6) 2018; DOR: (B)(6) 2019; (RIGHT HIP).

  Patient problems: No Code Available

  MAUDE report 8370892 ↗
• InjuryJan 28, 2019Appropriate Device Problem Term/Code Not Available

  LITIGATION ALLEGES PATIENT WAS REVISED DUE TO PAIN AND DISCOMFORT. UPDATE JUN 27, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY LITIGATED, PATIENT ALSO ALLEGES LIMITED MOVEMENT, HIGH LEVELS OF EMOTIONAL DISTRESS AND ANXIETY. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INCREASING HIP PAIN AND FAILED RIGHT TOTAL HIP ARTHROPLASTY. ON THE OPERATIVE NOTE IT WAS REPORTED THAT THE SERUM INFECTION MARKERS INCLUDING CBC WITH DIFFERENTIAL, ESR AND C-REACTIVE PROTEIN ARE ALL WITHIN NORMAL LIMITS. MRI OF THE RIGHT HIP SHOWS A SMALL FLUID COLLECTION WHICH REPRESENT A SMALL PSEUDOTUMOR.

  Patient problems: Anxiety; Discomfort; Embolism; No Code Available; Pain; Tissue Damage

  MAUDE report 8281021 ↗
• InjuryAug 23, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LINER WAS OUT OF THE PINNACLE SHELL AND ARD¿S BROKEN.

  Patient problems: No Code Available

  MAUDE report 6814998 ↗