PINNACLE 1219-36-154Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295014584), received between Aug 26, 2016 and Dec 26, 2025 — classified as 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Fracture; Device Dislodged or Dislocated; Noise, Audible; Fracture; Device Dislodged or Dislocated; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE EXACT DATE OF THE INLAY LUXATION IS UNCLEAR, THE PATIENT PRESENTED HIMSELF ON (B)(6) 2025 AS AN EMERGENCY IN MY OFFICE HOURS, HE REPORTED THAT IT WAS THE FIRST TIME LAST (B)(6) 2025 THERE WOULD HAVE BEEN A CRACKING IN THE HIP, BUT THEN NO PROBLEMS, THEN SUDDENLY ON THURSDAY THERE WOULD HAVE BEEN A CLEAR CRACKING AND RESTRICTED MOVEMENT. PRESENTATION IN THE OFFICE HOURS, HERE AN ASYMMETRIC POSITION OF THE HEAD IN THE PAN WAS SHOWN, UNDER PULL A CLICKING COULD BE HEARD, THUS PRESUMABLY INLAY FRACTURE AND/OR DISLOCATION. THE RELIEF OF THE FOREARM SUPPORT, THE FORMULATION OF AN ORTHOSIS, THE FOLLOWING DAY A DIFFERENCE IN ROTATIONAL LENGTH CT COULD BE ORGANIZED IN THE MEDICAL HOSPITAL SCHOOL, BUT THE CORRECT POSITION OF THE IMPLANTS WAS SHOWN, THE DECENTRATION OF THE HEAD WITH THUS CONFIRMATION OF THE PRESUMPTION OF AN INLAY INSUFFICIENCY DD FRACTURE. CONSEQUENTLY, CLARIFICATION OF THE REVISION AND INLAY CHANGE.

  Patient problems: Insufficient Information; Loss of Range of Motion

  MAUDE report 23897862 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED, DUE TO INFECTION. SURGEON CHANGED LINER AND HEADBALL. NO DELAY, NO ADVERSE EFFECTS. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20206213 ↗
• InjuryJul 23, 2024Naturally Worn; Naturally Worn

  THE PATIENT COMPLAINED OF A SICK SQUEAK. THE MARATHON INSERT WAS WORN.

  Patient problems: Insufficient Information

  MAUDE report 19808731 ↗
• InjuryFeb 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO RECURRENT DISLOCATIONS. DOI: (B)(6) 2016. DOR: (B)(6) 2024. RIGHT HIP. 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? YES. FACILITY NAME OF ORIGINAL IMPLANT: [HOSPITAL]. WAS DEVICE EXPLANTED? TRUE. HARDWARE/EXPLANT REMOVAL DUE TO: DISLOCATION. DID PATIENT REQUIRE REVISION SURGERY? TRUE. IF YES, DATE OF REVISION SURGERY? [DATE]. REASON FOR REVISION SURGERY: DISLOCATION. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. 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 18659916 ↗
• InjuryJan 3, 2024Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  THE DANISH MEDICINES AGENCY HAS BEEN INFORMED BY HOSPITAL OF AN INCIDENT WITH PINNACLE MARATHON POLYETHYLENE ACETABULAR LINER. ADDITIONAL EVENT INFORMATION: BROKEN AND LOOSE LINER WITH ASSOCIATED WEAR AND TEAR AT THE METAL PART AND THEREFORE THE CUP WAS REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18440883 ↗
• InjuryJan 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE UNKNOWN. PRIMARY DONE AT UNKNOWN DATE, PATIENTS HIP WAS DISLOCATED AND COULD NOT BE PUT BACK IN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16148223 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON HAD REMOVED IMPLANTS FOR INFECTION AT (B)(6) HOSPITAL. DR [SURGEON NAME] DOES NOT REQUIRE ANY CONTACT AS REMOVAL WAS FOR INFECTION ONLY. ORIGINAL SURGERY WAS DONE IN 2020. ORIGINAL SURGERY SURGEON WAS DR [SURGEON NAME]. ORIGINAL SURGERY HOSPITAL WAS AT (B)(6) HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 15214689 ↗
• MalfunctionJun 16, 2022Fracture; Fracture

  POLYETHYLENE RUPTURE 54 36MM +4 10º.

  Patient problems: Insufficient Information

  MAUDE report 14712313 ↗
• InjuryMay 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGERY SCHEDULED AND FOUND LEG LENGTHS EQUAL AND CUP SECURE. TO REPLACE WITH DUAL MOBILITY SYSTEM TO ENSURE STABILITY. SURGERY WAS SUCCESSFUL AND THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 14397595 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY THR ON (B)(6) 2018 WHERE A CORAIL PINNACLE WAS UTILISED (DR (B)(6), (B)(6) HOSPITAL). PATIENT HAS REPORTED THAT HE WAS UNHAPPY WITH THE HIP FROM THE OUTSET. PATIENT HAS PRESENTED WITH A PAINFUL HIP (AROUND THE GROIN, GREATER TROCH AND BUTTOCK - PATIENT HAS A NUMBER OF OTHER CONDITIONS AS WELL AS SPINAL FUSION SO SOME OF THE PAIN COULD BE DUE TO HIS BACK), PATIENT ALSO HAS A CLUNKING FEELING IN CERTAIN POSITIONS. ON REVIEWING THE X RAYS, THE FEMORAL STEM APPEARS TO BE IN A REASONABLE POSITION WITHOUT ANY SIGNS OF LOOSENING (ALTHOUGH IT MAY BE A LITTLE UNDERSIZED). THE ACETABULAR COMPONENT APPEARS TO BE TOO MEDIAL AND TOO SUPERIOR (INDICATING THAT THE ACETABULUM MAY HAVE BEEN OVER REAMED AT TIME OF INDEX SURGERY, IT APPEARS THAT THIS MAY HAVE REDUCED THE OVERALL LATERAL OFFSET. ON OPENING THE HIP (DR. (B)(6), (B)(6) HOSPITAL, (B)(6) 2021) THE HIP WAS MOVED THROUGH A ROM AND IT APPEARED TO BE IMPINGING ON BOTH SOFT TISSUE AND BONE. A DECISION WAS MADE TO REMOVE THE PINNACLE SHELL (WHICH WAS A WELL FIXED 54MM SHELL) AND REPLACE THIS WITH A LARGER ACETABULAR COMPONENT WHICH WOULD ALLOW THE CUP TO BE PLACED MORE LATERAL. BONE GRAFT WAS PLACED ON THE MEDIAL WALL/

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 12561532 ↗
• InjuryAug 30, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED POLY LINER AND FEMORAL HEAD DUE TO POLY WEAR. DOI: (B)(6) 2008; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 12383778 ↗
• MalfunctionMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY CAUSE OF PINNACLE MARATHON. INITIAL SURGERY WAS ON (B)(6) 2016.

  Patient problems: Insufficient Information

  MAUDE report 11791797 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11446221 ↗
• InjuryMar 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION TOTAL HIP REPLACEMENT. REASON FOR REVISION: INSTABILITY AND DISLOCATION. PRIMARY SURGERY CARRIED OUT ON (B)(6) 2008. A CONSTRAINED PINNACLE LINER WAS IMPLANTED. RIGHT SIDE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 11407064 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE SURGEON CHANGED THE POSITION OF THE CUP AT THE REVISION SURGERY. THE AFFECTED SIDE INVOLVED WAS THE RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11254506 ↗
• InjuryJan 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL REVISION HIP SURGERY DUE TO MULTIPLE DISLOCATIONS. PATIENT'S 36X54 +4/10 DEGREE POLY LINER AND 36 MM -2 FEMORAL HEADBALL WERE REMOVED AND REPLACED WITH A PINNACLE DUAL MOBILITY 54X47 LINER AND 28 MM TS +8.5 CERAMIC FEMORAL HEAD FOR STABILITY. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY NOTED. DOI: APPROXIMATELY 10 YEARS AGO, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11147267 ↗
• InjuryDec 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO DISLOCATE DUE TO HAVING PARKINSON'S. CHANGED LINER TO A CONSTRAINED AND NEW HEAD. DOI: (B)(6) 2017. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 10935345 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS. PFS ALLEGES PAIN AND LOSS OF MOBILITY AFTER THE FIRST REVISION. THERE WERE NO REVISION SURGERY REPORTED IN THE MEDICAL RECORDS. DOI: (B)(6) 2013. DOR: NOT REVISED (RIGHT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9916622 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANOTHER COMPANY¿S MODULAR STEM WAS REMOVED BECAUSE OF PSEUDOTUMOR. IMPLANTED DEPUY STEM AND SWAPPED OUT DEPUY POLY CUP LINER. DOI: (B)(6) 2012; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 9565749 ↗
• InjuryDec 3, 2019Fracture; Naturally Worn; Fracture; Naturally Worn

  CATASTROPHIC WEAR OF A PINNACLE MARATHON LINER IN A PINNACLE CUP, AFTER LESS THAN 2 YEARS REQUIRING REVISION SURGERY.

  Patient problems: Foreign Body Reaction; No Code Available; Tissue Damage

  MAUDE report 9401390 ↗
• InjuryOct 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: 2012; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9218389 ↗
• InjurySep 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES DISLOCATION. DOI: (B)(6) 2010 - DOR: NONE REPORTED (LEFT HIP). PATIENT IS BILATERAL PLEASE SEE (B)(4) FOR RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 9008266 ↗
• InjuryAug 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT BEING REVISED FOR CHRONIC DISLOCATION. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: (B)(6) 2012. DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8885662 ↗
• InjuryApr 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED HER TOTAL HIP. HIP WAS REDUCED, BUT LATER DISLOCATED AGAIN. THE SURGEON DECIDED TO REMOVE THE CUP AND LINER AND INSERTED A CONSTRAINED LINER FOR BETTER STABILITY. LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8518443 ↗
• InjuryFeb 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF PINNACLE CUP AND CERAMIC HEAD. INFECTION PRESENT. IMPLANTS REMOVED AND REPLACED WITH THE SAME SIZES. THE REASON FOR REVISION WAS INFECTION. THERE WAS NO SUGGESTION BY THE SURGEON THAT THE IMPLANTS WERE AT FAULT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8370381 ↗