NA 1365-60-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295034018), received between Oct 3, 2018 and Nov 18, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 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.

• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY DUE TO HIP DISCOMFORT. DURING THE SURGERY THE METAL LINER WAS REMOVED AND REPLACED WITH POLY LINER AND NEW CERAMIC HEAD BALL. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort

  MAUDE report 23584447 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT COMPLAINED ABOUT PAIN IN THE RIGHT HIP AND WANTED THE BEARING SURFACE CHANGED. SURGEON REMOVED THE 44 X 62 METAL LINER, AN APEX HOLE ELIMINATOR, AND A 44 -2 METAL HEAD. THE REMOVED PRODUCTS WERE RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED. THERE WAS NO SIGN OF ANY METAL DEBRIS IN THE JOINT SPACE. NO ABNORMAL WEAR NOTICED ON LINER OR HEAD. THE ORIGINAL CORAIL STEM AND PINNACLE SECTOR 62 CUP REMAINED IN THE PATIENT. SALES REP HAS IDEA OF LOTS AND SIZE OF CORAIL STEM. SURGEON CHANGED THE BEARING SURFACE AND HEAD. PATIENT WAS NOT PART OF ANY STUDY AND NO CEMENT WAS USED. SALES REP HAS ATTACHED A COPY OF THE NEWLY IMPLANTED ITEMS AND AN X-RAY SHOWING BILATERAL METAL-ON-METAL HIPS. DOI: (B)(6) 2007; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15507855 ↗
• InjuryApr 7, 2022Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  PINNACLE LITIGATION COMPLAINT RECEIVED AD 23 MAR 2022. REVISION COMPLETED DUE TO PAIN, EXCESSIVE AND TOXIC COBALT CHROMIUM TO WEAR, TISSUE AND BONE DESTRUCTION. PRIOR TO REVISION MRI SHOWS PSEUDOTUMOR FORMATION CONSISTENT WITH METALLOSIS. DOI: (B)(6) 2008; DOR: (B)(6) 2020 RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 14040178 ↗
• InjuryDec 21, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED AS METAL ON METAL HIP THAT MRI SHOWED EFFUSION. SOFT TISSUES WERE STAINED WITH METAL DEBRIS. PINNACLE METAL LINER EXPLANTED AND REPLACED WITH POLY LINER. PATIENT HAD ELEVATED COBALT LEVELS. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Swelling/ Edema

  MAUDE report 11051351 ↗
• InjuryOct 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION AND LOOSENING OF CUP AFTER FIRST REVISION. DOI: (B)(6) 2010; DOR: (B)(6) 2011; (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9193905 ↗
• InjurySep 13, 2019Naturally Worn; Naturally Worn

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ELEVATED METAL IONS AND METAL WEAR/METALLOSIS. DOI: (B)(6) 2008, DOR: (B)(6) 2017 (LEFT HIP).

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; No Code Available; Pain; Test Result

  MAUDE report 9025939 ↗
• InjuryMar 25, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR AND METAL WEAR.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Swelling; Test Result; Tissue Damage

  MAUDE report 8447911 ↗
• InjuryFeb 5, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PPF HAS NO ALLEGATION REPORTED BEFORE FIRST REVISION.

  Patient problems: No Code Available

  MAUDE report 8304671 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result

  MAUDE report 8270744 ↗
• InjuryOct 3, 2018Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  PATIENT ALLEGES THAT CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. IT IS FURTHER ALLEGED THAT THE PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND HIP AREA, AS WELL AS HIS GROIN. PATIENT HAS EXPERIENCED EPISODES OF A GRINDING AND POPPING SENSATION IN HIS LEFT HIP. DOI: (B)(6) 2009 - DOR: NONE REPORTED; (LEFT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 7930711 ↗