PINNACLE 1217-12-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295009177), received between Dec 6, 2017 and May 30, 2024 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE METAL ON METAL LITIGATION FORM RECEIVED. THE PATIENT HAD A HIP REVISION DUE TO OSTEOLYSIS AND ELEVATED METAL ION LEVELS. DOI: (B)(6) 2010 DOR: (B)(6) 2022 RIGHT HIP.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 19432073 ↗
• InjuryMay 21, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED: AS PER AEI NOTES PATIENT WAS REVISED DUE TO HIP PAIN, FEMORAL OSTEOLYSIS, OSTEONECROSIS, ELEVATED METAL IONS AND ASEPTIC LOOSENING OF TOTAL RIGHT HIP PROSTHESIS. DIAGNOSIS SURGERY SUSPECTED PSEUDO TUMOR/ALVAL, CLINICAL VISIT REPORTED ON (B)(6) 2021 REPORTED SEVERE STAGED DORSARTHIRSIS, LUMBO-DISCARTHROSIS, HIGHLY SUGGESTIVE ASPECT OF LOOSENING OF ARTHROPLASTY OF THE RIGHT HIP JUSTIFYING A TOMODENSITOMETRIC COMPLEMENT. ON (B)(6) 2022 REPORTED PAINFUL TOTAL RIGHT HIP PROSTHESIS, PATHOLOGICAL BONE REACTION OF THE RIGHT FEMORAL STEM. (B)(6) 2022 THERE WAS AN INFLAMMATORY SYNDROME RELATED TO AN OUTBREAK OF DIVERTICULITIS, COMPARATIVE ANALYSIS OF 2015 X-RAYS AND CURRENT X-RAYS SHOWS A NOTABLE INCREASE IN PROXIMAL FEMORAL OSTEOLYSIS. ON (B)(6) 2022: SUGGESTING ASEPTIC LOOSENING. DOI: (B)(6) 2010; DOR: (B)(6) 2022 ; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Loss of Range of Motion; Metal Related Pathology; Necrosis; Osteolysis; Pain

  MAUDE report 19359810 ↗
• InjuryJan 31, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  DOR: (B)(6) 2024.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 18613912 ↗
• MalfunctionSep 22, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON WAS PUTTING THE HOLE ELIMINATOR INTO THE CUP, AND THE HOLE ELIMINATOR WENT COMPLETELY THROUGH THE CUP. THE SURGEON DECIDED TO LEAVE IT BEHIND THE CUP, RATHER THAN REMOVING THE WELL-FIXED CUP. THERE WAS NOT A DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798976 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL HIP REPLACEMENT FOR INSTABILITY DISLOCATION. PRIMARY PROCEDURE BELIEVED TO PRE 2010 AT HOSPITAL. DATE UNKNOWN AND CANNOT BE SOURCED. REVISION TOTAL HIP REPLACEMENT IN 2012 (APPROXIMATE YEAR DATE UNKNOWN AND CANNOT BE SOURCED) HOSPITAL FOR MID SHAFT FEMORAL FRACTURE ALSO (PERI PROSTHETIC FRACTURE). NO COMPONENTS BELIEVE TO HAVE BEEN CHANGED DUE TO REPAIR OF THE FRACTURED FEMUR WHICH WAS REPAIRED USING A LONG BONE PLATE AND SCREWS. NO FURTHER INFORMATION IS AVAILABLE REGARDING ANY PREVIOUS PROCEDURE. THIS HAS BEEN SOUGHT BUT IS UNABLE TO BE SOURCED. NO PATIENT OR SURGEON CONSENT HAS BE GAINED FOR THE SHARING OF INFORMATION INCLUDING THAT APPEARING ON THIS DOCUMENT. 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, (B)(4). DEVICE PROPERTY OF -NONE, DEVICE IN POSSESSION OF -NONE, (B)(4). DEVICE PROPERTY OF -NONE, DEVICE IN POSSESSION OF -NONE, (B)(4). DEVICE PROPERTY OF -NONE, DEVICE IN

  Patient problems: Joint Laxity

  MAUDE report 17151329 ↗
• InjuryApr 17, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. THIS WAS PLANNED REVISION SURGERY. B. WAS ALL THE REPORTED PRODUCTS REVISED? NO. THE CUP, LINER, AND HEAD WERE REVISED AND THE STEM WAS LEFT.

  Patient problems: Foreign Body Reaction

  MAUDE report 16750766 ↗
• InjuryDec 21, 2022Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  REASON FOR REVISION WAS LINER DISASSOCIATION. THE SURGEON BELIEVES IT WAS NEVER SEATED CORRECTLY AT THE ORIGINAL SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 16022713 ↗
• 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 15214696 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO PAIN. ORIGINAL SURGERY PERFORMED 11 YEARS AGO. UPON DISLOCATING THE HIP THE SURGEON NOTED A BLACK STAIN ON THE FEMORAL HEAD. PROCEEDED TO EXPLANT THE ACETABULUM. HE NOTED ON REMOVAL THE CERAMIC LINER ALSO APPEARED TO HAVE A BLACK STAIN ON THE LINER. THE STEM STABILITY WAS ASSESSED AND THE STEM WAS NOT REVISED.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 14045013 ↗
• MalfunctionJul 6, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE HOLE ELIMINATOR WENT THROUGH CUP. NOT SURE WHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122477 ↗
• MalfunctionJul 6, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SURGEON HAD AN ISSUE WITH A HOLE ELIMINATOR GOING THROUGH A DUOFIX CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121895 ↗
• InjuryJan 29, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device 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 11254464 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS SURGICAL SITE INFECTION. OPERATIVE NOTE REPORTED A SMALL VOLUME OF SEROPURULENT FLUID AND NOTED TO EGRESS FROM BENEATH THE GLUTEUS MAXIMUS. DOI: (B)(6) 2010; DOR: (B)(6) 2010; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8687272 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON COMMENTED REASON FOR REVISION DUE TO STEM LOOSENING LIKELY CAUSED BY IMPLANT BEING UNDERSIZED WHICH HAS SUBSEQUENTLY CAUSED INFECTION.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 8599763 ↗
• InjuryAug 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, SWELLING, INFLAMMATION, INFECTION, AND DIFFICULTY AMBULATING. PPF ALLEGES INFECTION. UNKNOWN LINER AND HEAD WAS UPDATED AND ADDED CUP, SCREW AND STEM IN IMPACTED PRODUCT DUE TO ALLEGED INFECTION. DOI: (B)(6) 2009 - DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Inflammation; Not Applicable; Pain; Swelling; Unspecified Infection

  MAUDE report 7784160 ↗
• InjuryAug 14, 2018Osseointegration Problem; Osseointegration Problem

  CLAIMSUITE ALERTS RECEIVED. CLAIMSUITE ALLEGES LOOSENING OF THE METAL ON METAL CUP. DOI: (B)(6) 2008; DOR: (B)(6) 2009; LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7781173 ↗
• InjuryFeb 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF RIGHT THR - HIGH METAL IONS. PAIN. DOI: (B)(6) 2008; DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 7240911 ↗
• InjuryDec 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PINNACLE REVISION, RIGHT HIP. REASON FOR REVISION: PAIN AND ELEVATED METAL IONS. UPDATE (B)(6) 2017: PRODUCT STICKERS RECEIVED. UPDATED LOT NUMBER OF LINER. THIS COMPLAINT WAS UPDATED ON (B)(6) 2017.

  Patient problems: Pain

  MAUDE report 7088149 ↗