PINNACLE 1219-32-158Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295014089), received between Jan 14, 2019 and Dec 9, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO POLY DISENGAGED FROM CUP. THIS PATIENT HAD BOTH HIPS DONE ON TWO DIFFERENT DATES IN 2006 AND HAD THE EXACT SIZE IMPLANTS IN BOTH SIDES AND THE PAPERWORK FOR BOTH CASES WERE NEVER MARKED LEFT OR RIGHT. DOI: 2006, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) CREATED TO CAPTURE LEFT HIP. (B)(4) CREATED TO CAPTURE RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23762017 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES PAIN, LACK OF MOBILITY, SWELLING, SEVERE SORENESS, INFLAMMATION, AND DAMAGE TO SURROUNDING BONE AND TISSUE. PATIENT WAS ALREADY DIED. DATE OF DEATH: UNKNOWN. DOI: (B)(6) 2003. DOR: UNKNOWN. LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inflammation; Loss of Range of Motion; No Code Available; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 10076550 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 9610422 ↗
• InjuryJan 7, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE SURGEON TOLD ME TODAY ANOTHER CASE OF LINER BREAK IN HIS PATIENTS. NOW WE HAVE THIS NEW CASE IN WHICH THE (B)(6)-YEAR-OLD PATIENT HAD A LINER BREAK CAUSING THE PROSTHESIS HEAD TO DISLOCATE WITH JUST 1 YEAR AND 3 MONTHS OF SURGERY. THE PATIENT WILL UNDERGO A NEW SURGERY NEXT SATURDAY, (B)(6) 2019 AND THE DOCTOR REQUESTS TO USE IN THE PATIENT AN ALTRX INSTEAD OF MARATHON DEVICE. IMPLANTATION SURGERY:(B)(6) 2018. EXPLANTATION SURGERY: (B)(6) 2019 (SCHEDULED).

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 9559548 ↗
• InjuryJan 14, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  REVISION NOTES STATED THAT THERE WAS SOME CLOUDY YELLOW FLUID IN THE JOINT. SIGNIFICANT AMOUNT OF GRANULOMATOUS MATERIAL WAS ENCOUNTERED. HEAD AND LINER WERE REMOVED. PATIENT HAD ELEVATED COBALT AND A NORMAL CHROMIUM LEVEL.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Limited Mobility Of The Implanted Joint; Necrosis; No Code Available; Osteolysis; Pain; Tissue Damage; Unspecified Infection; Weakness

  MAUDE report 8244318 ↗