PINNACLE 1219-32-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295013914), received between Sep 8, 2017 and Jun 26, 2026 — classified as 45 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (34 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PINNACLE MARATHON LINER DISASSOCIATED FROM 54MM CUP. HEAD AND LINER WERE REPLACED. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 25643861 ↗
• MalfunctionFeb 23, 2026Naturally Worn; No Apparent Adverse Event

  BROKEN CERAMIC HIP HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416433 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HEMATOMA AND SUSPECTED INFECTION IN THE HIP, DURING WHICH THE POLYETHYLENE LINER AND FEMORAL HEAD WERE REPLACED FOLLOWING IRRIGATION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 24099920 ↗
• InjuryJan 6, 2026Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POLY FAILURE. THE PINNACLE MARATHON LINER APPEARING DETACHED FROM THE ARDS ON ONE SIDE. THE CUP AND HEAD WERE NOTED TO BE IN GOOD CONDITION, REPLACED THE LINER AND HEAD WITH ALTRX 54+4 10D AND A 36+1.5 TS CERAMIC HEAD. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23978895 ↗
• InjuryNov 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LEFT HIP WEAR ON THE POLY. POLY SWAP WENT SMOOTH WITH NO PROBLEMS. DOI- UNKNOWN, DOR (B)(6) 2025, AFFECTED SIDE- LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23480830 ↗
• InjuryAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR REVISION SURGERY DUE TO LINER DISASSOCIATION. SURGEON WILL BE REMOVING AND REPLACING THE CUP AND LINER. THE OPERATING SURGEON FEELS THERE MUST BE AN ISSUE WITH THE LOCKING MECHANISM FOR THE CUP.

  Patient problems: Insufficient Information

  MAUDE report 22725232 ↗
• InjuryMay 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY. A PINNACLE LINER HAS DISASSOCIATED FROM THE CUP. THE CUP WAS NOT REVISED, BUT SURGEON NOTED THERE WAS DAMAGE TO THE CUP WITH THE CERAMIC HEAD ARTICULATING AGAINST IT. INITIAL PROCEDURE WAS DONE A FEW WEEKS PRIOR.

  Patient problems: Insufficient Information

  MAUDE report 22047660 ↗
• InjuryJul 11, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  A PATIENT WHO HAD RECEIVED SUCCESSFUL TOTAL HIP ARTHROPLASTY SURGERY PRESENTED WITH HIP PAIN AND AUDIBLE SQUEAKING AFTER REPORTEDLY FALLING OUT OF BED. X-RAYS WERE TAKEN APPEARED TO SHOW A PRESUMPTIVE LINER DISSOCIATION. REVISION SURGERY WAS PERFORMED WHICH CONFIRMED THAT THE MARATHON 32/54 NEUTRAL LINER HAD DISSOCIATED FROM THE PINNACLE 54MM SECTOR GRIPTION SHELL. THE 32 +1 CERAMIC FEMORAL HEAD HAD SUSTAINED DAMAGE IN THE FORM OF STRIPE WEAR AND WAS EXPLANTED. THE DISSOCIATED LINER WAS DAMAGED AND A COUPLE OF FRAGMENTS HAD BROKEN OFF. THE LINER AND THE TWO FRAGMENTS WERE SUCCESSFULLY EXPLANTED. AFTER INSPECTING THE SHELL, THERE APPEARED TO BE SOME DAMAGE TO ONE SIDE OF THE INTERIOR OF THE SHELL. THE SHELL WAS SUBSEQUENTLY EXPLANTED. SURGEON PROCEEDED TO REAM THE ACETABULUM UP TO SIZE 55MM AND THEN IMPLANT A 56MM SECTOR GRIPTION SHELL, FOLLOWED BY A 36/54 NEUTRAL ALTRX LINER, AND FINALLY A 36MM +1.5MM FEMORAL HEAD. HIP WAS REDUCED AND SURGERY WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Fall; Pain

  MAUDE report 19721114 ↗
• InjuryOct 11, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THIS PINNACLE INSERT WAS REMOVED FROM PATIENT AFTER DISLOCATING. DURING THE REMOVAL IT WAS DISCOVERED THAT MOST OF THE ARD TABS WERE GONE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17914214 ↗
• InjuryOct 6, 2023Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  THE REVISION WAS DONE YESTERDAY AFTERNOON (B)(6) 2023 ONLY ITEM 1219-32-054 WAS REVISED. IT HAD DISASSOCIATED FROM THE SHELL 121732054 (WHICH REMAINS IN SITU). ALL BUT TWO ARD¿S HAD SHEERED OFF. PLACED NEW 32 N LINER. HE SAID THE PATIENT REPORTED A CLUNKING SOUND IN THE WEEK PRIOR. NO ISSUES UP UNTIL THIS POINT. DOI: (B)(6) 2017. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17887032 ↗
• InjuryJun 28, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  REVISION OF A CORAIL PINNACLE DUE TO POLY LINER DISLOCATION FROM THE CUP. ONLY THE HEAD AND LINER WERE REVISED. CONVERTED TO PINNACLE DUAL MOBILITY. ONCE THE LINER WAS REMOVED IT COULD BE SEEN THAT THERE WAS WEAR ON ONE SIDE OF THE LINER WHERE THE CERAMIC HEAD WAS ARTICULATING. SOME OF THE ARD'S WERE WORKED AWAY, AND THERE WAS WEAR ON THE CERAMIC HEAD WHERE IT HAD BEEN ARTICULATING ON THE INSIDE OF THE PINNACLE CUP. DOI: (B)(6) 2019. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 17218338 ↗
• InjuryApr 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE AFFECTED SIDE INVOLVED WAS THE LEFT HIP AND THERE WAS NO SURGICAL DELAY REPORTED IN THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16752383 ↗
• InjuryApr 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. THIS WAS PLANNED REVISION SURGERY. 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 16750756 ↗
• MalfunctionJan 24, 2023Difficult to Insert; Difficult to Insert

  THE SURGON IMPLATED A 54ER PINNACLE CUP, BUT THE CORRESPONDING INLAY 121932054/LOT: 3940101/EXPERIY DATE: 30.09.2027 DID NOT FIT. THEY OPEN A NEW INLAY AND IT COULD THEN BE INSERTED IN THE USUAL WAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232172 ↗
• 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 16022714 ↗
• InjuryFeb 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP PATIENT CONTACTED A FRIEND WHO IS J&J EMPLOYEE: HIP PATIENT RECEIVED HIP-TEP LEFT SIDE IN (B)(6) 2021. HE IS NOW SUFFERING FROM A LEG LENGTH DISCREPANCY. THE LEFT LEG IS 1.4 TO 3.0 CM SHORTER THAN THE RIGHT ONE. IN ADDITION, THE HIP HEAD DISLOCATED FROM THE CUP. A TREATMENT WAS DONE NON-INVASIVE. ANY MOVEMENT IS ONLY POSSIBLE WIT HELP OF CRUTCHES. DOI: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Dislocation; Loss of Range of Motion; Physical Asymmetry

  MAUDE report 13472437 ↗
• InjuryDec 23, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  REVISION OF THA COMPLETED. ACETABULAR CUP AND POLY LINER WAS DISSOCIATED FROM ONE ANOTHER. LINER HAD SIGNIFICANT WEAR AND TEAR. ORIGINAL COMPONENTS WERE REPLACED WITH 56MM CUP, A MARATHON POLYETHYLENE +4 NEURAL 36/56 LINER AND 36MM +1.5 FEMORAL HEAD. DOI: UNKNOWN, DOR: UNKNOWN, UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 13078355 ↗
• InjuryDec 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON REVISED AN APPROX. 6 YEARS OLD MARATHON PINNACLE INLAY WHO WAS LUXATED. DOI: APPROX. 6 YEARS AGO, DOR: UNKNOWN, UNKNOWN SIDE.

  Patient problems: Joint Laxity

  MAUDE report 12910449 ↗
• InjuryNov 15, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD SEVERE POLY WEAR ON A 20+ YEAR OLD MARATHON LINER (PINNACLE CUP), SO IT WAS REMOVED AND A PINNACLE ALTRX WAS IMPLANTED. PATIENT NOTICED A CLICKING TYPE NOISE. THE STEM WAS A G2 WHICH STAYED, BUT THE HEAD WAS REMOVED AND A 36-2 WAS IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12813507 ↗
• InjuryAug 13, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PATIENT HAD A THP CORAIL WITH DAA APPROACH IN 2017, NO POST OP COMPLICATION AND EVERYTHING WENT WELL. PATIENT WAS JUST DOING SOME NORMAL ACTIVITY AT HOME ( CLOSING THE CURTAINS) WHERE HE FELT SOMETHING WRONG, LIKE SOMETHING POPPED OUT, NO PAIN, NO FALLING OR LIMITATION OF MOVEMENT JUST A VERY LOUD SQUEEZING SOUND IN EVERY MOVEMENT. THE ORTHOPEDIC SURGEON DID A HIP REVISION TO SOLVE THE PROBLEM.

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

  MAUDE report 12320067 ↗
• InjuryAug 5, 2021Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  ARTICLE ENTITLED "POLYETHYLENE LINER DISSOCIATION IN A DEPUY PINNACLE CUP WITH A MANUFACTURER ANALYSIS OF THE FAILED COMPONENT¿ WRITTEN DAVID KEOHANE, GERARD A SHERIDAN, JAMES HARTY, AND PADHRAIG O¿LOUGHLIN PUBLISHED BY BMJ ON JANUARY 2, 2021 WAS REVIEWED. THE ARTICLES PURPOSE WAS TO PRESENT A CURRENT CASE REPORT OF A LINER FAILURE ACCOMPANIED BY A DETAILED ENGINEERING LABORATORY ANALYSIS. (B)(6) FEMALE WHO HAD A LEFT THA IN 2010. IN (B)(6) 2019 WITH ATRAUMATIC LEFT-SIDED HIP PAIN. THE PATIENT HAD BEEN TRYING TO LIFT AN OBJECT AT HOME WHEN SHE HEARD AN AUDIBLE CRACK FROM HER HIP WHICH WAS ASSOCIATED WITH ACUTE HIP PLAN AND AN INABILITY TO WEIGHT BEAR. IN THE ED, RADIOGRAPHS DEMONSTRATED LATERALIZATION OF THE LEFT FEMORAL HEAD WITHIN THE ACETABULAR SHELL. DISASSOCIATION WAS CONFIRMED. REVISION OCCURRED. ENGINEERING FINDINGS: -LINER HAD WEAR ON THE SURFACE EDGE AND DEFINED SCRATCHES -DAMAGE TO TAPER AND INNER DOME SUGGESTING ARTICULATION OF THE HEAD AGAINST THESE SURFACES, MOST LIKELY TO HAVE OCCURRED POST-LINER DISASSOCIATION. -ON INSPECTION 3 OF THE 6 ARDS WERE SHEARED AWAY DEPUY PRODUCTS: 54MM PINNACLE ACETABULAR SECTOR II CUP ((B)(4)). SUPERIOR SCREW. 32MM NEUTRAL MARATHON LINER

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12285489 ↗
• InjuryMar 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS A CHRONIC DISLOCATOR. REMOVED FEMORAL HEAD AND LINER AND CONVERTED TO A CONSTRAINED INSERT. ORIGINAL IMPLANT. DATE UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11506787 ↗
• InjuryMar 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2021, THE PATIENT DISLOCATED WITH "LUXATION OF THE HEAD IN THE CUP WITH INLAY DISLOCATION." METALLOSIS WAS FOUND AS WELL AS A TILTED INLAY FOR UNKNOWN REASON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Foreign Body Reaction; Joint Dislocation

  MAUDE report 11436598 ↗
• InjuryFeb 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(6) 2012 PATIENT RECEIVED PRIMARY LEFT THA FOR COXARTHROSIS. PRIMARY OPERATIVE NOTES SURGEON INITIALLY UTILIZING TRILOCK TRAILING BUT SWITCH TO CORIAL TRAILING SYSTEM TO ACHIEVE ROTATIONAL STABILITY. ALSO NOTED IS THE REMOVAL OF ACETABULAR RIM OSTEOPHYTES DURING TRAILING DUE TO IMPINGEMENT BUT EVENTUAL SUCCESSFUL IMPLANTATION ACHIEVING EQUAL LEG LENGTHS WITH SELECTED SIZES (PGS. 18, 24-29). (B)(6) 2015 PATIENT RECEIVED A FOLLOW UP X-RAY WITH RESULTS OF ¿THE HEAD OF THE PROSTHESIS, WHICH USED TO BE PROPERLY SEATED IN THE PROSTHESIS CUP, IS CURRENTLY CLEARLY DECENTERED IN THE CRANIAL DIRECTION, INDICATING AN INLAY PROBLEM. NO VISIBLE SIGNS OF LOOSENING. NO PERIPROSTHETIC FRACTURE DEMONSTRATED. NO SUBSEQUENT SINTERING OF THE PROSTHESIS.¿ PATIENT ALSO REPORTS SQUEAKING FOR OVER A MONTH BUT NO PAIN OR DISCOMFORT (PG. 21). PATIENT ALSO REPORTED FEELING LEFT LEG WAS SHORTENED (PG. 31) AND RESTRICTED MOVEMENT (PG. 27). (B)(6) 2015 PATIENT RECEIVED REVISION WITH INTRAOPERATIVE FINDINGS THAT THE INLAY ¿DISLOCATED¿ FROM CUP AND CUP HAD SIGNS OF WEAR REQUIRING REPLACEMENT. ALSO NOTED WAS SCARRING AND OSTEOPHYTIC ACCRETION REQUIRING OSTEOPHYTES TO BE REMOVED. A NEW CERAMIC FEMORAL HEAD WITH

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Physical Asymmetry

  MAUDE report 11329333 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEGAL CLAIM LETTER RECEIVED FROM ATTORNEY ON OCT 5, 2020. HIP SURGERY WAS PERFORMED ON (B)(6) 2019. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. COMPENSATION CLAIM WITH REGARD THE HIP ENDOPROSTHESIS DEPUY SYNTHES DUE TO WHICH A PSEUDOTUMOR OF THE FEMUR IS SUPPOSED TO BE DIAGNOSED.

  Patient problems: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Inflammation; No Code Available; Pain

  MAUDE report 10697898 ↗