PINNACLE 1219-36-452Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295014706), received between Nov 26, 2013 and Jan 22, 2026 — classified as 51 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (25 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. SURGEON CONVERTED TO CONSTRAINED LINER. THERE WAS NO DELAY AND NO HARM DONE TO PATIENT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24145040 ↗
• InjuryNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION HIP SURGERY BECAUSE THE PINNACLE MARATHON LINER SEEMED TO HAVE BROKEN WHICH LEAD TO THE METAL FEMORAL HEAD RUBBING AGAINST THE METAL CUP. THE CUP, LINER AND HEAD WERE ALL CHANGED AND THE STEM WAS RETAINED WITH NO DAMAGE TO IT.

  Patient problems: Insufficient Information

  MAUDE report 23452657 ↗
• InjuryMay 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. NEEDED MORE CONSTRAINT. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22003507 ↗
• InjuryApr 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT IS REPORTING THAT POST SURGERY ONE LEG IS NOW LONGER THAN THE OTHER.

  Patient problems: Joint Dislocation; Pain; Physical Asymmetry

  MAUDE report 21912890 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED A PAINFUL POSSIBLE INFECTION. THE PATIENT UNDERWENT A REVISION FOR WASH OUT AND EXCHANGE OF THE HEAD AND LINER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21068453 ↗
• InjuryNov 19, 2024Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO ACETABULAR REVISION FOR MALPOSITIONED COMPONENT WITH POLY WEAR. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20724838 ↗
• InjuryOct 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE PRODUCT WAS TAKEN OUT, WENT CONSTRAINED. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20517142 ↗
• InjuryJul 2, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PINNACLE MOM MEDICAL RECORDS RECEIVED. REASON FOR REVISION, DUE TO DISLOCATION RIGHT THA. OPERATIVE NOTE REPORTED, ABDUCTORS WERE DEFICIENT, TROCHANTER WAS BALD, THERE WAS SOME WEAR ON THE SUPERIOR ASPECT OF THE ACETABULAR COMPONENT. IN ADDITION, TO DEFICIENT ABDUCTORS, WHY DISLOCATION WAS OCCURRING. PRIOR TO IMPLANTING, WE USED BONE GRAFT TO RECONSTRUCT THE ANTERIOR WALL. WHICH WAS SLIGHTLY DEFICIENT. ROUGHENED UP THE BALD TROCHANTER TO GET SOME BLEEDING BONE AND REATTACHED THE PORTION OF THE ABDUCTORS WAS FOUND TO THE GREATER TROCHANTER. VASTUS REPAIRED. DOI: (B)(6) 2010; DOR: (B)(6) 2016; AFFECTED AREA: RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 19656274 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED RIGHT HIP. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18055967 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED RIGHT HIP. NO ADDITIONAL INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16940855 ↗
• InjuryApr 27, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO SUDDEN INSTABILITY OF HIP A FEW WEEKS AGO. DOI: (B)(6) 2010. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16823351 ↗
• InjuryApr 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THERE WERE NO DELAYS OCCURRED DURING REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 16783929 ↗
• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR LEFT HIP INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15657415 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY, SO THE SURGEON PUT A NEW FACE CHANGING LINER AND A LONGER HEAD. NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS NOT REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15650501 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL THA. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 15445650 ↗
• InjuryJan 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLE REMOTE RELATION TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2008, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 13385152 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. PERFORMED I&D WITH HEAD AND LINER EXCHANGE. DOI: (B)(6) 2017, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12908940 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN INFECTED RIGHT THA. I&D WITH HEAD AND POLY EXCHANGE. THERE WAS NO SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 12758731 ↗
• InjuryMay 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11805799 ↗
• InjuryJan 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS MULTIPLE DISLOCATIONS. DOI: (B)(6) 2013, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11223969 ↗
• InjuryJan 22, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED IN 2010, THE EXACT DATE WAS UNKNOWN. THIS PATIENT CAME IN BECAUSE OF GRINDING SENSATION IN HER HIP WHERE X-RAYS INDICATED THE HIP WAS SLIPPING OUT AND THE HIP. ALL WAS ARTICULATING IN THE RIM OF THE CUP. PHYSICIAN SCHEDULED THIS PATIENT FOR A REVISION AND FOUND THE HIP BALL HAD BEEN ARTICULATING ON THE EDGE OF THE POLY LINER WHICH HAD FRACTURED AND THE PINNACLE SHELL HAS SEVERE DAMAGE DUE TO THE 36MM COCR FEMORAL HEAD. THE WOUND WAS FULL OF METAL DEBRIS DUE TO THE WEAR AND WAS DEBRIDED BY SURGEON. THE FEMORAL HIP BALL, 52MM PINNACLE LINER, AND A PINNACLE CUP WERE EXPLANTED. A NEW COMPETITORS CUP WITH FEMORAL AUGMENTS AND A DEPUY TS CERAMIC FEMORAL HEAD WAS REPLACED ONTO THE STEM. THE SUMMIT STEM WAS WELL FIXED AND LEFT IN SITU. NO INFORMATION WAS AVAILABLE TO RECORD ABOUT THE STEM BECAUSE IT WAS TO DIFFICULT FOR THE SURGEON TO READ. NO SURGICAL DELAY. DOI: 2010. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 11216534 ↗
• InjuryJan 13, 2021Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALLOSIS AND POLYETHYLENE FAILURE. OPERATIVE NOTE REPORTED BARE BONE ON THE FEMORAL HEAD AND ACETABULUM WITH MARK OSTEOPHYTES ON THE ACETABULUM. ENCOUNTERED A BLACKISH SYNOVIAL FLUID, THERE WAS BLACK TISSUE IN THE TROCHANTERIC BURSA THESE WERE ALL REMOVE. SYNOVIUM WAS BLACKENED ANTERIORLY. SUPERIOR FRAGMENT HAD FRACTURED POLYETHENE. CLINICAL VISIT REPORTED PAIN, GRINDING WITH RANGE OF MOTION, DEPRESSION, ANXIETY, SLEEP DISORDER AND NUMBNESS. X-RAY REVEALED HAD SIGNIFICANT POLY WEAR OR POSSIBLE FRACTURE RIGHT HIP. ALLEGED ELEVATED METAL IONS HOWEVER COBALT AND CHROMIUM BLOOD RESULT SHOWS BELOW 7 PPB. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED IN THE MEDICAL RECORDS AND AFTER REVIEW THE PATIENT WAS REVISED TO ADDRESS GRINDING WITH ANY RANGE OF MOTION, NUMBNESS, DEPRESSION, ANXIETY, SLEEP DISORDER, TENDERNESS OVER THE GROIN, LIMITED RANGE OF MOTION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discomfort; Fall; Fatigue; Foreign Body Reaction; Inflammation; Loss of Range of Motion; Numbness; Pain; Pulmonary Embolism; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 11164546 ↗
• InjuryJan 13, 2021Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  THE PFS MENTIONS: TISSUE DAMAGE, DEEP VENOUS THROMBOSIS, PULMONARY EMBOLISM, ANTIPHOSPHOLIPID SYNDROME, NEED FOR CHRONIC ANTICOAGULATION THERAPY, AT RISK FOR A MULTITUDE OF ISSUES INCLUDING FALLS, TWO SECONDARY REVISION SURGERIES TO REPLACE THE FAULTY DEVICES, EXTENSIVE REHABILITATION, ECONOMIC LOSS, PAIN AND SUFFERING THAT BEGAN IN 2011. THE PFS MENTIONED CONTINUED PAIN AND UNABLE TO LIFT RIGHT LEG DUE TO PAIN AND LIMITATIONS IN MOVEMENT OF RIGHT HIP DUE TO METALLOSIS AND TISSUE DAMAGE. ON (B)(6) 2010, PATIENT HAD A LEFT HIP ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. THE PATIENT HAD A DISCHARGE DIAGNOSIS OF ACUTE BLOOD LOSS ANEMIA, STATUS POST LEFT TOTAL HIP ARTHROPLASTY. DEPUY PRODUCTS WERE PLACED DURING THIS PROCEDURE. ON (B)(6) 2010, THE PATIENT HAD A RIGHT HIP ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE. (B)(6) 2019 MEDICAL RECORDS NOTE PATIENT IS RETURNING FOR FOLLOW-UP FOR RIGHT HIP. PATIENT HAS HAD SEVERE GROIN PAIN. MEDICAL CONDITION INCLUDES: PHLEBITIS, PULMONARY EMBOLISM. *NO MENTION OF WHEN THE PULMONARY EMBOLISM OCCURRED. ON (B)(6) 2019, THE PATIENT

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discomfort; Fall; Fatigue; Fibrosis; Foreign Body Reaction; Inflammation; Loss of Range of Motion; Numbness; Pain; Physical Asymmetry; Pulmonary Embolism; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 11164503 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTED HIP; REMOVED ALL COMPONENTS, PERFORMED I&D AND RE-IMPLANTED TOTAL HIP. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10154977 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR METALLOSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY DEFINITELY RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2002. DATE OF EVENT: (B)(6) 2020. (RIGHT HIP). TREATMENT INCLUDES PLANS FOR REVISION BUT NO INDICATION A REVISION HAS TAKEN PLACE.

  Patient problems: Foreign Body Reaction; No Code Available; Pain

  MAUDE report 9938887 ↗