PINNACLE 1219-36-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295014461), received between Aug 11, 2017 and Feb 18, 2026 — classified as 31 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CONE OF A CEMENTLESS HIP PROSTHESIS FRACTURED. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2023. IT IS UNKNOWN WHEN THE REVISION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378992 ↗
• InjurySep 9, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LINER DISASSOCIATED WITH THE CUP. SEVERE METALOSIS. DOI: (B)(6) 2012, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 23008791 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INDEX CORAIL PROCEDURE WITH PINNACLE CUP ON (B)(6) 2015. THE FOLLOWING YEAR, THE PATIENT GOT HIT BY A BUS, AND SUFFERED FRACTURES TO HIS ANKLE. AFTER THIS INCIDENT PATIENT HAD AN INFECTION AND HAS NEVER RESOLVED. HE HAD DECLINED A REVISION OF THE COMPONENTS AT THAT TIME, BUT HAS NOW EXPERIENCED INCREASED PAIN. THE IMPLANTS WERE ALL REMOVED AND DISCARDED BY THE HOSPITAL AND TEMPORARY IMPLANTS WERE PLACED. THE PLAN IS TO PERFORM THE SECOND STAGE REVISION AT THE BEGINNING OF(B)(6) 2024.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20385890 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT LINER EXCHANGE WAS OCCURRING FOR PINNACLE HIP. PATIENT HAD PRESENTED WITH PAIN TO ED IN HIP, SAMPLES TAKEN FOR INFECTION STATUS. ORIGINAL IMPLANTS PLACED IN 2018. UNABLE TO GET ORIGINAL IMPLANT DETAILS. NEW IMPLANTS THAT WERE EXCHANGED WERE 58/36 LINER, ALONG WITH A CERAMIC FEMORAL HEAD 36/+5. NO FURTHER INFORMATION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19557622 ↗
• InjuryAug 9, 2023Fracture; Device Dislodged or Dislocated; Material Deformation; Fracture; Device Dislodged or Dislocated; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM SALES REP: INFORMATION RECEIVED FROM SURGEON 'LINERS IN PLACE IN SITU BUT DEFORMED AND ROTATING FREELY AND LUGS DESTROYED.' PLEASE UPDATE LINER FOR DEFORMED/BENT, IMPLANT DISASSOCIATION AND ADD IP FOR CUP FOR DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 17487460 ↗
• InjuryAug 9, 2023Fracture; Device Dislodged or Dislocated; Material Deformation; Fracture; Device Dislodged or Dislocated; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM SALES REP: INFORMATION RECEIVED FROM SURGEON 'LINERS IN PLACE IN SITU BUT DEFORMED AND ROTATING FREELY AND LUGS DESTROYED.' PLEASE UPDATE LINER FOR DEFORMED/BENT, IMPLANT DISASSOCIATION AND ADD IP FOR CUP FOR DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 17487427 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDEX PROCEDURE (B)(6) 2014, PATIENT COMPLAINED OF IMPINGEMENT AND HAD A PSOAS RELEASE PROCEDURE IN 2018, THIS RESOLVED THE ISSUE BUT DUE TO SCAR TISSUE FORMATION THE IMPINGEMENT RETURNED. THE ACETABULAR CUP WAS ASSESSED TO BE IN A NEUTRAL ANTEVERTED POSITION AND SLIGHTLY CLOSED DOWN. THE PLAN WAS TO REMOVE THE CUP AND REPLACE A NEW ONE, REPOSITION IT MORE ANTEVERTED AND SLIGHTLY MORE INCLINED. CUP WAS REMOVED WITH EXPLANT, THE CUP HAD EXCELLENT BONEY INGROWTH AND TOOK SOME TIME TO REMOVE, DEFINITELY NOT LOOSE. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? LIMITED RANGE OF MOTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: X-RAYS, REVISION PROCEDURE, IS THE PATIENT PART OF A CLINICAL STUDY: NO, (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. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOS

  Patient problems: Joint Laxity; Loss of Range of Motion; Scar Tissue

  MAUDE report 15418016 ↗
• InjuryAug 25, 2022Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PATIENT UNDERWENT AN ACETABULAR REVISION OF HER PRIMARY HIP ON THE (B)(6) 2021 (INITIAL COMPONENT WAS A STRYKER CUP AND STEM. PATIENT HAD A FALL RESULTING IN THE NEED FOR THE PRIMARY REVISION). THE PATIENT HAS BEEN COMPLAINING OF PAIN AND SQUEAKING IN HER HIP FOR A FEW WEEKS, SO THE SURGEON DID A FOLLOW UP X-RAY AND NOTED THAT THE LINER OF THE PINNACLE CUP USED IN THE REVISION IN 2021 HAD FAILED AND THAT THE PATIENT REQUIRED RE-REVISION OF THE HEAD AND LINER. UPON OPENING THE PATIENT, IT WAS NOTED THAT THE PINNACLE LINER HAD DISSOCIATED FROM THE PINNACLE SHELL AND THAT THE HEAD WAS ARTICULATING ON THE INSIDE OF THE SHELL. THERE WERE SIGNS OF METALOSIS IN THE TISSUES IMMEDIATELY AROUND THE HIP JOINT, THERE WERE ALSO SIGNS OF WEAR ON THE FEMORAL HEAD AND ACETABULAR SHELL. THE SURGEON ELECTED TO REVISE THE FEMORAL HEAD (STRYKER IMPLANT) AS WELL AS REPLACE THE PINNACLE LINER WITH A NEW ONE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Discomfort; Fall; Foreign Body Reaction; Pain

  MAUDE report 15293165 ↗
• InjuryJul 27, 2022Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  REVISION WAS DUE TO THE PINNACLE LINER BEING DISASSOCIATED FROM THE SHELL. THE CERAMIC HEAD WAS ARTICULATING DIRECTLY INTO THE PINNACLE SHELL. THE ARDS OF THE LINER HAD EITHER BEEN WORN AWAY OR HAD BROKEN OFF. DOI: UNK. DOR: UNK. UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 15111711 ↗
• InjuryJul 6, 2022Use of Device Problem; Use of Device Problem

  REVISION OF HEAD AND LINER FROM A PATIENT WHO HAD HIS PRIMARY PROCEDURE DONE ON IN EITHER 207-2008 BY THE SURGEON. PATIENT WAS UNSTABLE DUE TO THE LIP ON THE LINER BEING POSITION IN THE WRONG POSITION FROM THE PREVIOUS SURGERY. SIDE WAS THE LEFT SIDE. NEW LINER AND HEAD IMPLANTED WITH THE ORIENTATION OF THE LIP POSITION DIFFERENTLY. AWAITING CUSTOMER SERVICE TO SEARCH FOR USAGE OF THE POLY REMOVED. UNABLE TO READ IMPLANT DUE TO DAMAGE OF THE LINER WHEN REMOVING, BUT I WAS ABLE TO GET USED OF THE HEAD.

  Patient problems: Joint Laxity

  MAUDE report 14938260 ↗
• InjuryNov 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY OF TOTAL HIP DUE TO LOOSENING OF LINER. SURGEON STATED LINER APPEARED TO SPIN OUT. DOI: UNKNOWN; DOR: (B)(6) 2021; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 12892270 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED HIP-TEP LEFT SIDE ON (B)(6) 2018. AFTER INITIAL SURGERY THE PATIENT SUFFERED STABBING PAIN DURING BENDING, KNEELING, LIFTING LOADS AND STANDING. REVISION ON (B)(6) 2021 WITH CHANGE OF STEM, HIP-HEAD AND PE INLAY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11952115 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR REVISION WAS DUE TO INFECTION. PATIENT HAD A REVISION IN THE PAST FOR A WASH OUT AND A HEAD AND LINER EXCHANGE. PATIENT WAS EXPERIENCES INFECTION SYMPTOMS EARLY AFTER PRIMARY SURGERY. THEY PERFORMED THE WASHOUT TO TRY AND CLEAR THE INFECTION WITHOUT HAVING TO REMOVE THE STEM AND CUP. DURING THE REVISION, ALL COMPONENTS WERE REMOVED (AS LISTED IN IMPACTED PRODUCTS) AND A CEMENTED CUP AND CEMENTED STEM WERE IMPLANTED AS A SPACER FOR THE MEANTIME. THIS PATIENT WILL BE BACK IN A FEW MONTHS ONCE THE INFECTION HAS CLEARED SO THE DEFINITIVE PROSTHESIS CAN BE IMPLANTED. A 36 REVISION CERAMIC HEAD WAS ALSO REMOVED BUT I WAS UNABLE TO RETRIEVE THE LOT NUMBER.

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

  MAUDE report 11047265 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A CORAIL PINNACLE DUE TO INFECTION. THE CONTACT AT THE HOSPITAL TOLD ME THAT THIS PATIENT HAS HAD A REVISION IN THE PAST FOR A WASH OUT AND A HEAD AND LINER EXCHANGE. DURING THE REVISION, ALL COMPONENTS WERE REMOVED AND A CEMENTED CUP AND CEMENTED STEM WERE IMPLANTED AS A SPACER FOR THE MEANTIME. THIS PATIENT WILL BE BACK IN A FEW MONTHS ONCE THE INFECTION HAS CLEARED SO THE DEFINITIVE PROSTHESIS CAN BE IMPLANTED.

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

  MAUDE report 10947339 ↗
• InjuryJun 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SURGEON WAS PLANNING ON REVISING A PINNACLE LINER AND HEAD FOR A PATIENT THAT UNDERWENT A PRIMARY DAA THR ON (B)(6) 2020. THE SURGEON REPORTED REASON FOR REVISION WAS DUE TO THE PATIENT DISLOCATING FOLLOWING THE PRIMARY PROCEDURE WHILST STILL AN INPATIENT FOLLOWING THE PRIMARY PROCEDURE. SURGEON ADVISED PATIENT WOULD REQUIRE A NEW LINER/ LINER CONFIGURATION TO IMPROVE HIP JOINT STABILITY. REVISION SURGERY COMPLETED AS PLANNED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10167330 ↗
• InjuryMay 26, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  HOSPITAL INFORMED ME OF A USAGE RE-SUPPLY REQUEST FOR AN OPERATION COMPLETED ON (B)(6) 2020 WHERE BY PATIENT UNDERWENT A REVISION OF A RIGHT ACETABULAR LINER AND FEMORAL HEAD FOR A LINER DISSOCIATION. SURGEON INFORMED THAT PATIENT REPORTED HEARING A CRACK WHILE SNOWBOARDING FOLLOWED BY AUDIBLE SQUEAKING WHEN WALKING AND SURGEON REPORTED THAT FOLLOW UP IMAGING SHOWS FEMORAL HEAD ARTICULATING WITH ACETABULAR SHELL.

  Patient problems: No Code Available

  MAUDE report 10088173 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION AND/OR ALLEGATION REPORTED FOR INVOLVED DEPUY PRODUCT. DOI: (B)(6) 2004; DOR: NONE REPORTED; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9720386 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES LIMITED RANGE OF MOTION AND WEAKNESS. PPF ALLEGES INFECTION. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT WAS REVISED FOR FAILED LEFT THA SECONDARY TO INFECTION AND A STAGE 1 OF 2 REVISION WAS PERFORMED. OPERATIVE NOTES AND DATE OF SURGERY WERE NOT PROVIDED. DOI: (B)(6) 2008 (CUP AND STEM), DOI: (B)(6 2010 (HEAD AND LINER), DOR: UNKNOWN (1ST STAGE REVISION), LEFT HIP.

  Patient problems: Fatigue; Loss of Range of Motion; No Code Available; Unspecified Infection

  MAUDE report 9139705 ↗
• InjuryJun 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS REVISION OF LOOSE STEM (NOT DEPUY) AND EXCHANGED POLY LINER. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8666750 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. HEAD AND LINER EXCHANGE. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8579487 ↗
• InjuryMar 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND ELEVATED METAL IONS. DOI: (B)(6) 2011 - DOR: NONE REPORTED (RIGHT HIP) SECOND REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8444903 ↗
• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP, FRACTURE (COMPONENT), METAL WEAR AND METALLOSIS. DOI: (B)(6) 2008; DOR: (B)(6) 2009; (RIGHT HIP). PATIENT IS BILATERAL.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8390613 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS A SURGERY FOR JOINT WASHOUT, REMOVAL AND RE-IMPLANTATION OF PROSTHESES DUE TO AN ASA GRADE 2 WOUND INFECTION. THE IMPLANT DATE WAS (B)(6) 2019. THE LEFT HIP WAS AFFECTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8349787 ↗
• InjuryDec 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE ON (B)(6) 2009 DEBRIDEMENT WITH LINER AND HEAD EXCHANGE AT NEWTON WELLESLEY HOSPITAL. CULTURES REVEAL POLY BACTERIAL INFECTION MAINLY WITH PROPIONIBACTERIUM ACNES AS WELL AS MRSA AND MSSA AS WELL AS A 3RD TYPE STAPHYLOCOCCUS. PATIENT HAD FEVER EPISODES 2 DAYS LATER AFTER DISCHARGE ON (B)(6) 2009. DESPITE EXTENSIVE TREATMENT THE PATIENT DID SHOW CLINICAL DETERIORATION WITH PRONOUNS DRAINAGE OF THE RIGHT HIP INCISION CLEARLY WITH PUS CONTENTS, FEVER EPISODES AND INCREASE INFLAMMATORY MARKERS. THE PATIENT WAS THEN REVISED FOR POLYBACTERIAL PERIPROSTHETIC RIGHT HIP INFECTION. OPERATIVE NOTES REPORTED THAT THERE WERE 2 DRAINING OPENING IN THE MID AND DISTAL PART OF THE INCISION. THERE WAS GROSS INFECTION IN ALL THE TISSUE PLAINS, INCLUDING SUBCUTANEOUS, FASCIA LATA AND ABDUCTOR MUSCLE AND THE ACTUAL JOINT SPACE. THE FEMORAL NECK AND THE ACETABULUM SHOWED IMPINGEMENT TRACES IN EXTENSION WITH SIGNIFICANT METAL SUBSTANCES LOSS WELL EXPLAINING THE PREVIOUSLY NOTED METALLOSIS. AN ATTEMPT WAS MADE TO DISCONNECT THE SLEEVE FROM THE MAIN STEM COMPONENT USING J J WEDGE OSTEOTOME, DESPITE ENORMOUS EFFORT, THIS WAS NOT ACCOMPLISHED. THEN NE

  Patient problems: Cellulitis; Fever; Fluid Discharge; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Necrosis; No Code Available; Tissue Damage; Unspecified Infection

  MAUDE report 8200187 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7969119 ↗