PINNACLE 1219-28-144Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295013433), received between Feb 26, 2018 and Jun 22, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 25580185 ↗
• InjuryJul 24, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A THR SURGERY IN (B)(6) 2024 AND WITHIN 1 YEAR PATIENT HAD TO COME BACK TO THE SURGEON ON ACCOUNT OF COMPLAINT OF SEVERE PAIN. UPON X-RAY EXAMINATION IT WAS FOUND THAT THE LINER HAS BEEN DISLOCATED. LINER DISSOCIATION IS A PROBLEM WITH PINNACLE CUP. THIS IS A SERIOUS PROBLEM CAUSING CATASTROPHIC POLY WEAR, METALLOSIS AND INSTABILITY. REVISION SURGERY WITHIN ONE YEAR.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 22588544 ↗
• InjuryMay 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY IN OUR HOSPITAL AND RETURNED TO NORMAL AFTER THE SURGERY. ABOUT 3 YEARS AFTER THE SURGERY, THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO JOINT SOUND WHEN WALKING. AFTER EXAMINATION, IT WAS FOUND THAT THE LINER DETACHED (THE SPECIFIC SITUATION WAS UNKNOWN, AND THE LINER WAS NOT FRACTURED). THE DOCTOR GAVE A SECOND SURGERY FOR REVISION. THE PATIENT HAS BEEN DISCHARGED UNEVENTFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22002852 ↗
• InjuryFeb 24, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THE LINER WEAR POST-OP & DEVICE PROTRUDE. PATIENT HAD PAIN ON WALKING. THE PATIENT UNDERWENT TOTAL HIP REPLACEMENT PROCEDURE AT (B)(6) 2020. IN (B)(6) 2025, THE LINER WAS FOUND TO BE WORN, AND THE DEVICES WERE FOUND PROTRUDE. REVISION SURGERY COMPLETED (B)(6) 2025. BOTH THE HEAD AND CUP WERE REPLACED AT REVISION. DOI: (B)(6) 2020. DOR: (B)(6) 2025.

  Patient problems: Pain

  MAUDE report 21445807 ↗
• InjuryOct 3, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY REPORTED AND THE AFFECTED SIDE INVOLVED WAS THE LEFT HIP. THE CUP WAS NOT EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 20362029 ↗
• MalfunctionJun 12, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER IS LOOSE. DURING THE SURGERY, IT WAS DISCOVERED THE LINER COULD NOT BE LOCKED WITH THE CUP. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521636 ↗
• InjuryApr 12, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LINER USED IN SIZE 44 PINNACLE SHELL, IN CONJUNCTION WITH CORAIL STEM & CERAMIC HEAD. THE LINER IS WORN AWAY WHERE IDENTIFYING NUMBERS ARE LOCATED SO UNABLE TO RETRIEVE SOME OF THE IDENTIFIERS.

  Patient problems: Insufficient Information

  MAUDE report 19099391 ↗
• InjurySep 21, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE PATIENT PRESENTED PAIN AND INSTABILITY OF THE OPERATED HIP, WHICH IS WHY AN X-RAY WAS TAKEN THAT SHOWED DISPLACEMENT OF THE IMPLANTS. ADDITIONAL SURGERY WAS REQUIRED TO REMOVE THE IMPLANTS AND REPLACE THEM WITH OTHERS. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17787957 ↗
• InjurySep 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISLOCATION OF POLYETHYLENE, WHEN THE HEAD CONTACTED WIHT THE CUP, PART OF THE CUP WAS ATE. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING?UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? A NWE INTERVACITION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN. IP-01520034. DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. IP-01520035. DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. IP-01520036. DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Insufficient Information

  MAUDE report 15418362 ↗
• MalfunctionAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSTRUMENT IS FRACTURED.

  Patient problems: Insufficient Information

  MAUDE report 15173714 ↗
• InjuryJul 2, 2021Naturally Worn; Naturally Worn

  HIP REVISION DUE TO THE LINER COMPONENT HAVING TOO MUCH DEBRIS AFTER 4 YEARS AND 4 MONTHS OF IMPLANTATION. PATIENT EXPERIENCED PAIN, METALLOSIS, AND FEMORAL BONE DEGRADATION DUE TO POLYWEAR. DOR: (B)(6) 2021.

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

  MAUDE report 12106714 ↗
• InjuryAug 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD REVISION OF THE LEFT HIP PROSTHESIS ((B)(6) 2020) FOR HIP DYSPLASIA, WITH A PREVIOUS 5CM SHORTENING, AND IN SURGERY THEY PERFORM A FEMORAL OSTEOTOMY TO REDUCE THE PROSTHESIS. HE REFERS FROM THE IMMEDIATE POST OP TO PRESENTED INTENSE PAIN IN THE LEFT HIP, WHICH DOES NOT IMPROVE WITH ANALGESICS, LIMITS HIS GAIT AND MOVEMENTS OF THE HIP IN TOTAL HIP REPLACEMENT FOR DYSPLASIA, HOSPITALIZED FOR DISLOCATION OF THE HIP PROSTHESIS, CURRENTLY WITH TRACTION OF SOFT TISSUES WITH 3 KG OF WEIGHT, PATIENT WHO IS AFEBRILE, PAINLESS, WITH SHORTENING, ALREADY SCHEDULED FOR SURGERY.

  Patient problems: Adhesion(s); Hematoma; Joint Dislocation; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10409667 ↗
• InjuryFeb 26, 2018Disassembly; Disassembly

  DR (B)(6), (B)(6) HOSPITAL, PRIMARY: (B)(6) 2015. REVISION TO BE SCHEDULED. RADIOLOGY FILMS INDICATED DISASSOCIATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7295703 ↗