PINNACLE 1219-36-454Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295014713), received between Jan 3, 2018 and Apr 29, 2025 — classified as 31 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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. How this data works · Data updated Oct 13, 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.

• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ALL PARTS WERE REMOVED DUE TO INFECTION OF THE HIP JOINT. THERE WAS STEM LOOSENING FROM INFECTION AT THE NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21924949 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. WASHED OUT AND CHANGED THE LINER AND HEAD BALL. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21207887 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE CUP, LINER AND STEM WERE ALL REMOVED AND REPLACED WITH PROSTALAC SPACER. DOI: UNKNOWN , DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20258298 ↗
• InjuryNov 13, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT HAD POLY WEAR. SURGEON DID HEAD AND LINER EXCHANGE. PINNACLE CUP AND SUMMIT STEM RETAINED. DOI: (B)(6) 2007. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18117971 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED FOLLOWED BY A HEAD AND LINER SWAP. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17227100 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF RIGHT HIP. NO ADDITIONAL INFORMATION PROVIDED. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15995546 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15941580 ↗
• InjuryNov 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2012, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15796956 ↗
• InjuryAug 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATING HIP. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12276123 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO TREAT INFECTION. DOI: UNK DOR: (B)(6) 2021 UNKNOWN HIP.

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

  MAUDE report 11711355 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  MEDICAL RECORDS RECEIVED. OFFICE NOTES (B)(6) 2021, INDICATE THE PATIENT IS EXPERIENCING PAIN, INSTABILITY, SUBLUXATION, AUDIBLE POPPING SOUNDS AND LIMP. REVISION OPERATIVE NOTES (B)(6) 2021, INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REVISION DUE TO RECURRENT INSTABILITY. OPERATIVE FINDINGS INCLUDE IMPINGEMENT OF THE NECK OF THE STEM ON THE POLY LINER, THIS CAUSED A DENT/WEAR SPOT ON THE LINER. HEAD AND LINER WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

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

  MAUDE report 11704517 ↗
• MalfunctionAug 27, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE PATIENT WAS DIAGNOSED WITH OSTEOARTHRITIS OF THE HIP JOINT AND UNDERGO TO HIP REPLACEMENT SURGERY WITH THE CEMENTLESS SYSTEM CORAIL ¿ PINNACLE POLYETHYLENE ON METAL HEAD. THE SURGERY WAS PERFORMED WITH POSTERIOR-LATERAL APPROACH. SURGEON REAMED ACETABULUM PROGRESSIVELY TILL 52MM, 54 PINNACLE WITH GRIPTION COATING WAS IMPACTED. AFTER THAT THE SURGEON INSERTED 3 CANCELLOUS 6.5MM SCREWS AND APEX HOLE ELIMINATOR. NEXT STEP WAS INSERTING PINNACLE MARATHON LINER 54 +4MM WITH ID 36MM. SURGEON NOTICED MISMATCH IN DIMENSION OF THE SHELL AND LINER. HE CHECKED THE IMPLANTS AND WAS NOTICED THE SHELL WAS WITH DIMENSION 52MM OD . DUE TO GOOD PRIMARY FIXATION HE DECIDED TO LEAVE THE IMPLANTED SHELL IN PLACE. AFTER THAT WAS INSERTED PROPERLY LINER 52MM +4MM WITH 36MM ID. NEXT STEP WAS BROACHING OF FEMUR WITH CORAIL BROACHES UNTIL LONGITUDINAL AND ROTATIONAL STABILITY IS ACHIEVED WITH SIZE 9. TRIAL PROSTHESIS WAS PERFORMED WITH BROACH IN SITU AND AFTER THAT WAS INSERTED CORAIL STD 135 STEM SIZE 9 AND METAL HEAD 36MM - 2. THE SURGERY WAS EXTENDED WITH 20 MIN DUE TO MISMATCH - 121732052 52MM SHELL WAS PACKED IN 121732055 54 BOX.

  Patient problems: No Code Available

  MAUDE report 10459728 ↗
• InjuryAug 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED MULTIPLE TIMES. DOI: (B)(6) 2015. DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10408207 ↗
• InjuryMar 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD , PATIENT WAS REVISED TO ADDRESS DISLOCATION. REVISION NOTES STATED THAT A SMALL AMOUNT OF CLEAR YELLOW FLUID WAS ENCOUNTERED AROUND THE HIP. THE SYNOVIUM HAD A BENIGN APPEARANCE. HEAD AND LINER WERE REMOVED. DOI: (B)(6) 2007, (B)(6) 2009, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9831408 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES INJURIES AND LIMITED MOBILITY AFTER FIRST REVISION. DOI: (B)(6) 2015, DOR: NONE REPORTED (LEFT HIP, SECOND EVENT) PLEASE SEE (B)(4) FOR THE LEFT HIP FIRST REVISION.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 9520121 ↗
• InjuryAug 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES DISLOCATION AND ELEVATED METAL IONS. DOI: (B)(6) 2014 ; DOR: (B)(6) 2017, (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8911507 ↗
• InjuryAug 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES DISLOCATION AND LOOSENING OF STEM AFTER THE FIRST REVISION. ONLY THE MARATHON POLY LINER WAS REPORTED TO THE IMPACTED PRODUCT, THE STEM AND HEAD WERE NON-DEPUY PRODUCTS. DOI: (B)(6) 2007 . DOR: DEC 23, 2010 (RIGHT HIP) SECOND REVISION. PLEASE SEE (B)(4) FOR THE RIGHT HIP FIRST REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8880028 ↗
• InjuryApr 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. UPDATE IN ADDITION TO PREVIOUS ALLEGATION, PPF ALLEGES DISLOCATION. DOI: (B)(6) 2013 - DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8517933 ↗
• InjuryApr 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION. DOI: (B)(6) 2014 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8513959 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR, STROKE/HEART ATTACK AND ELEVATED METAL IONS AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THERE WERE NO REVISION NOTES PROVIDED OR REPORTED. DOI: (B)(6) 2009 (CUP); DOI: (B)(6) 2016 (HEAD AND LINER); DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Cardiac Arrest; Infarction, Cerebral; Tissue Damage

  MAUDE report 8455415 ↗
• InjuryFeb 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PENDING PRODUCT LIABILITY REPORTS: IT WAS ALLEGED THERE WAS DISLOCATION AFTER FIRST REVISION. THE INCIDENT INVOLVED THE LEFT HIP. THE IMPLANT DATE WAS (B)(6) 2006. NO REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 8330714 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AFTER FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8250623 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS BEFORE FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8242123 ↗
• InjuryDec 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES DISLOCATION WITH CLOSED REDUCTION. THE HEAD IS A NON DEPUY PRODUCT.

  Patient problems: Joint Dislocation

  MAUDE report 8165514 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ABDUCTOR MUSCLE REPAIR AND INFECTION AFTER FIRST REVISION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 8046287 ↗