PINNACLE 1219-32-148Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10603295014034), received between Aug 11, 2017 and Jul 28, 2026 — classified as 74 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (38 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 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was premature replacement head and polyethylene.

  Patient problems: Insufficient Information

  MAUDE report 50056050 ↗
• InjuryMar 19, 2026Fracture

  IT WAS REPORTED THAT SURGEON PERFORMED A SURGERY WHERE THEY REPLACED INSERT 32/48 WHICH WAS ORIGINALLY IMPLANTED TWO YEARS AGO. THE INSERT WAS CRACKED.

  Patient problems: Insufficient Information

  MAUDE report 24638892 ↗
• InjuryFeb 26, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REPLACEMENT OF THE POLYETHYLENE DUE TO PREMATURE WEAR OF POLYETHYLENE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461173 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED HIP PAIN, WITH PROGRESSIVE WORSENING AND INABILITY TO WALK. IMAGING EXAMS (RADIOGRAPHY AND TOMOGRAPHY) WERE PERFORMED, WHICH SHOWED LOSS OF CONCENTRICITY OF THE FEMORAL HEAD, RAISING THE HYPOTHESES OF LOOSENING OF MODULAR COMPONENTS (FEMORAL HEAD AND ACETABULAR LINER) OR MATERIAL FAILURE, INDICATING A NEW SURGICAL APPROACH FOR CORRECTION.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 24056107 ↗
• InjuryDec 31, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INSERT DISLOCATED AND CRACKED AFTER 2 YEARS.

  Patient problems: Insufficient Information

  MAUDE report 23935417 ↗
• InjuryDec 15, 2025Fracture; Fracture

  AN IMPLANT WAS REMOVED FROM A PATIENT. THE ACETABULAR INSERT BROKE AFTER TWO YEARS OF IMPLANTATION.

  Patient problems: Insufficient Information

  MAUDE report 23802243 ↗
• InjurySep 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT NEEDED TO BE REVISED DUE TO PAIN. A CRACK IN THE LINER WAS VISIBLE. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 23028778 ↗
• InjuryMay 9, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THE PATIENT EXPERIENCED PINNACLE ACETABULAR INSERT FAILURE; THE POLYETHYLENE IS WORN AND THE INSERT RUPTURED. THE IMPLANT WAS CORRECTLY POSITIONED. THE PATIENT HAD RECOVERED THEIR FUNCTION AND THEN BEGAN TO COMPLAIN OF MECHANICAL SYMPTOMS AFTER A FEW YEARS.

  Patient problems: Insufficient Information

  MAUDE report 21993382 ↗
• InjuryMay 7, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THERE WAS AN ABNORMAL PINNACLE ACETABULAR INSERT FAILURE. THE WEAR OF POLYETHYLENE AND THE RUPTURE OF THE INSERT ARE INEXPLICABLE, THE IMPLANT WAS CORRECTLY POSITIONED, THE PATIENT HAD PERFECTLY RECOVERED ITS FUNCTION AND SUDDENLY BEGAN TO COMPLAIN OF MECHANICAL SYMPTOMS AFTER A FEW YEARS.

  Patient problems: Insufficient Information

  MAUDE report 21979283 ↗
• MalfunctionJan 15, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE INSERT COULD NOT BE LOCKED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A TWENTY (20) MINUTES DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158424 ↗
• InjuryJan 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS A PREMATURE WEAR OF POLYETHYLENE.

  Patient problems: Insufficient Information

  MAUDE report 21142119 ↗
• InjuryOct 17, 2024Fracture; Fracture

  IT WAS REPORTED OCTOBER 8, 2021 A POLYETHYLENE BROKE. IT IS UNCLEAR WHEN THE REVISION TOOK PLACE. NO INFORMATION ON IMPLANT DATE.

  Patient problems: Insufficient Information

  MAUDE report 20469740 ↗
• MalfunctionOct 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE ACETABULAR INSERT RUPTURED.

  Patient problems: Insufficient Information

  MAUDE report 20367806 ↗
• InjuryJul 17, 2024Fracture; Fracture

  FEMALE PATIENT OPERATED AT HOSPITAL ONE YEAR AGO. DURING TRAINING FELT A DIFFERENCE AND A NOISE IN THE HIP AND AFTERWARDS PAIN. THE EXPLANTED IMPLANTS SHOW SIGN OF IMPINGEMENT AND MAYBE BROKEN PARTS OF THE 10 DEG LIPP. DOI: (B)(6) 2023. DOE: 04 JUL 2024.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19760809 ↗
• InjuryJul 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE EDGE OF THE POLYETHYLENE WAS BROKEN OFF FROM THE BODY OF THE IMPLANT. ALL PIECES WERE REMOVED FROM THE PATIENT, AND THE CAUSE OF THE BREAKAGE AS WELL AS THE IMPLANT DATE WERE UNKNOWN. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 19648485 ↗
• InjuryMay 9, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  CUSTOMER INFORMED US ABOUT AN EXPLANTATION OF AN UNKNOWN HIP IMPLANT. ADDITIONAL EVENT INFORMATION: REASON FOR REVISION WAS DUE TO INLAY WEAR WITH CONSECUTIVE DE-CENTERING OF THE FEMORAL HEAD. SURGERY TIME WAS PROLONGED DUE TO DISTINCT METALLOSIS. AFFECTED SIDE: LEFT.

  Patient problems: Foreign Body Reaction; Joint Dislocation

  MAUDE report 19281656 ↗
• InjuryFeb 7, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT RECEIVED CORAIL - PINNACLE SYSTEM BEFORE 3 MONTHS WAS HOSPITALIZED DUE TO LUXATION AND DUBIETY FOR FRACTURE IN ARTIFICIAL JOINT. 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.)?-- LUXATION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: -- YES. IF YES, DESCRIBE -- REVISION TO BE PERFORMED. IS THE PATIENT PART OF A CLINICAL STUDY -- UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). 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: Joint Dislocation

  MAUDE report 18659737 ↗
• InjuryDec 1, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PATIENT OPERATED PRIMARY AT A PRIVATE HOSPITAL IN (B)(6) 2020. SYMPTOMS STARTED IN JANUARY 2023 JARRING NOISE. PATIENT UNDERWENT A REVISION OF THE CUP/LINER ON (B)(6) 2023. HEAD WAS WORN THROUGH THE LINER, AND HEAD MOVED AGAINST THE CUP, A LOT OF METALLOSIS. SURGEON TOOK OUT THE CUP AND INSERTED ANOTHER CUP NOT FROM DEPUY SYNTHES. THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body Reaction

  MAUDE report 18246585 ↗
• InjuryNov 27, 2023Naturally Worn; Naturally Worn

  THIS COMPLAINT IS COVER THE SECOND REVISION SURGERY: THE PATIENT HAD A SECOND OPERATION TO REMOVE THE INSERT AGAIN DUE TO WEAR, WHICH TOOK PLACE ON 07-28-2022. COMPLAINT CREATED TO CAPTURED THE SECOND REVISION SURGERY FIRST REVISION IS CAPTURED UNDER THE (B)(4).

  Patient problems: Pain

  MAUDE report 18210070 ↗
• InjuryAug 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. PINNACLE CUP, LINER, ARTICULEZE HEAD WERE REMOVED AND REPLACED WITH DUAL MOBILITY CONSTRUCT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17641129 ↗
• InjuryAug 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS OPERATED WITH CORAIL - PINNACLE POLY ON METAL SYSTEM IN (B)(6) 2021 AND IN (B)(6) 2023 BECAUSE OF SQUEAKING IN HIP JOINT THE PATIENT VISITED HCP. AFTER ADDITIONAL X-RAY IT WAS OBSERVED THAT THE HEAD IS ARTICULATING IN PINNACLE CUP.

  Patient problems: Insufficient Information

  MAUDE report 17612527 ↗
• InjuryAug 24, 2023Naturally Worn; Naturally Worn

  PINNACLE REVISION. DUE TO SUPERIOR POLYETHYLENE WEAR. DOI: UNKNOWN. DOE: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17611403 ↗
• InjuryApr 4, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE PATIENT ACCUSED A SEVERE JOINT PAIN AT THE LEFT HIP WITH FUNCTIONAL IMPOTENCE WITHOUT PARTICULAR TRAUMA. IT WAS DIAGNOSED A RUPTURE/DISLOCATION OF THE ACETABULAR IMPLANT (IMPLANTED ON (B)(6), 2015 AT GALEAZZI HOSPITAL). THE PATIENT WAS SUBJECTED TO A LEFT HIP REVISION SURGERY WHERE IT WAS CONFIRMED THE RUPTURE OF THE ACETABULAR PE INSERT. IT WAS ALSO REPLACED THE HEAD (THAT HAD NO SIGN OF WEARING). DEVICE REPLACED WITH BIOBALL IMPLANT ON (B)(6), 2021, PATIENT HAD UNDERGO A SECOND SURGERY AT THE ZUCCHI CLINIC IN ORDER TO REMEDY THE BREAKAGE OF THE PROSTHESIS, IN PARTICULAR OF THE POLYETHYLENE ACETABULAR INSERT OF THE PROSTHESIS OF THE LEFT HIP PERFORMED ON (B)(6) 2015. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON, TO WHOM THIS LETTER IS SENT FOR ALL LEGAL PURPOSES, WHO USED CERAMIC, POLYETHYLENE AND METAL COMPONENTS IN THE TOTAL LEFT HIP ARTHROPLASTY PERFORMED ON (B)(6) 2015 WHICH IN THE MEDICAL RECORDS APPEAR TO BE MANUFACTURED BY DEPUY AND BIOLOX DELTA . ON (B)(6) , WHILE PATIENT WAS IN HER HOME, THE PATIENT FELT THE SENSATION THAT SOMETHING WAS CRUMBLING IN HER PROSTHETIC HIP WITH THE CONSEQUENT IMPOSSIBILITY OF WALKING: THE DIAGNOSIS OF THE HOSPITAL OF VIMERCATE FOLLOWI

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16673081 ↗
• InjuryMar 6, 2023Naturally Worn; Naturally Worn

  THE PATIENT UNDERWENT SURGERY ON (B)(6) 2021. ON (B)(6) 2023, SHE WENT BACK TO THE DOCTOR CLAIMING TO HAVE PAIN AND DISCOMFORT. SHE UNDERWENT REVISION SURGERY, REMOVING THE ACETABULAR CUP AND LINER; IMPLANTING MATERIALS FROM OTHER ORTHOPEDICS. DOI: (B)(6) 2021. DOR: (B)(6) 2023. UNKNOWN HIP.

  Patient problems: Discomfort; Pain

  MAUDE report 16486036 ↗
• InjuryJan 27, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT NOTICED "CRACKING" AT THE AREA OF THE RIGHT HIP SINCE ABOUT 4 MONTHS. THE PAIN EXTENDS TO THE SPINE. NO KNOWN TRAUMA. AFTER IMPLANTATION OF A RIGHT HIP.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16252686 ↗