PINNACLE 1219-32-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295014324), received between Oct 8, 2018 and Aug 9, 2024 — classified as 26 injuries, 3 malfunctions.

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. 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2024Fracture; Noise, Audible; Fracture; Noise, Audible

  A YEAR AND A HALF AGO, A DOCTOR INSTALLED A CORAIL-PINNACLE PROSTHESIS FOR A PATIENT WITH A CERAMIC-POLYETHYLENE FRICTION PAIR. PATIENT REPORTED THAT 2 WEEKS AGO SHE HEARD A CRUNCH WHEN MOVING THE JOINT, AND CONTACTED THE DOCTOR. THE PATIENT UNDERWENT A REVISION OF THE HIP JOINT DUE TO A FRACTURE OF THE LINER. THE DOCTOR REPLACED THE HEAD. NUMBER OF PATIENTS INVOLVED - 1. THE PATIENT IS IN HOSPITAL, HER CONDITION IS SATISFACTORY.

  Patient problems: Pain

  MAUDE report 19949137 ↗
• InjuryJun 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT EXPERIENCED HIP DISLOCATION. SURGEON BROUGHT TO OR TO CHANGE TO A DUAL MOBILITY ARTICULATION. THERE WAS NO DELAY. AFFECTED SIDE: RIGHT. ORIGINAL SURGERY - (B)(6) 2024

  Patient problems: Joint Dislocation

  MAUDE report 19632517 ↗
• InjuryMay 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A DISLOCATION OF THE HIP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 19297499 ↗
• InjuryJul 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. THE HEAD AND LINER WERE EXCHANGE TO CONSTRAINED LINER. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17267504 ↗
• InjuryFeb 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO CUP/LINER DISASSOCIATION. THIS PC IS ASSOCIATED WITH (B)(4) IN WHICH THE BROKEN NECK IS ADDRESSED.

  Patient problems: Insufficient Information

  MAUDE report 16378571 ↗
• InjuryDec 8, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SHELL WAS IN A BAD POSITION. ECCENTRIC POLY, WHERE BECAUSE OF THAT, AND DID A HEAD SHELL POLY EXCHANGE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNK.

  Patient problems: Insufficient Information

  MAUDE report 15942140 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF UNKNOWN COMPONENT AT UNKNOWN INTERFACE. WASHOUT DONE A HEAD & LINER WERE EXCHANGED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15793159 ↗
• InjuryNov 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF A CORAIL PINNACLE THR. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2012. THE REASON FOR REVISION WAS DUE TO INSTABILITY/DISLOCATION. THE HEAD AND LINER WERE REMOVED SO THE CUP COULD BE CONVERTED TO A PINNACLE DUAL MOBILITY. THE CUP AND STEM WERE NOT REVISED. AS IT WAS DONE A WHILE AGO, THE PATIENT NOTES WERE UNAVAILABLE. I WAS UNABLE TO GET THE LOT NUMBERS OR REFERENCE NUMBER SHOWING WHAT WAS REMOVED. THE LINER WAS EITHER 122132050, 121932450 OR 121928050. IT WAS ALSO A DELTA CERAMIC HEAD WHICH WAS REMOVED. UNSURE OF WHAT LENGTH. FEMALE. LEFT SIDE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15760751 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ACETABULAR COMPONENTS OF A HIP-TEP. DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15587603 ↗
• InjuryMar 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO CHRONIC DISLOCATIONS. DOI: (B)(6) 2018; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 13690670 ↗
• MalfunctionMar 4, 2022Naturally Worn; Naturally Worn

  THE SURGEON HAVE SEEN A PATIENT FOR A FIVE YEAR FOLLOW UP FOR A HIP ARTHROPLASTY. WHEN HE LOOKED AT THE XRAYS HE SAW SOMETHING THAT HE FOUND SUSPICIOUS. THE POLY LINER SEEMS TO SHOW ANORMAL WEAR IN THE SUPERIOR ASPECT OF IT.

  Patient problems: Insufficient Information

  MAUDE report 13667038 ↗
• InjuryMay 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED AND UNABLE TO REDUCE WITHOUT OPENING AND EXPOSING JOINT. SURGEON REPLACED LINER AND HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 11805080 ↗
• InjuryFeb 15, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  ON (B)(6) 2011, THE PATIENT HAD A LEFT HIP JOINT RESURFACING DUE TO COMBINED CAM AND PINCER IMPINGEMENT (MIXED TYPE) NO MENTION OF MANUFACTURER OF COMPONENTS PROVIDED. ON (B)(6) 2012 THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY. THE INDICATION FOR SURGERY ARISES IN THE CASE OF ADVANCED OSTEOARTHRITIS OF THE HIP JOINT ON THE LEFT, STATUS POST HIP JOINT RESURFACING AT THIS FACILITY IN 11/2011. AFTER EXHAUSTING THE CONSERVATIVE TREATMENT OPTIONS AND GRADUAL REDUCTION IN WALKING DISTANCE AND MOBILITY, AND PAIN, THE PATIENT NOW WISHES TO HAVE A TOTAL HIP REPLACEMENT. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS REVISED DUE TO VERIFIED INLAY DISLOCATION IN THE PRESENCE OF A TOTAL HIP REPLACEMENT ON THE LEFT SIDE, THE PATIENT WAS ADMITTED FOR PLANNED INPATIENT TREATMENT TO REPLACE THE INLAY AND, IF NECESSARY, THE CUP. PRIOR TO SURGERY THE PATIENT WAS EXPERIENCING PAIN. ONLY THE FEMORAL HEAD AND ACETABULAR LINER WERE REVISED. DURING THE PROCEDURE THE SURGEON OBSERVED MULTIPLE, SMALL POLYETHYLENE FRAGMENTS, THAT WERE THEN REMOVED. THE LINER LIP WAS NOTED TO HAVE ¿BROKEN OFF¿ OR FRACTURED. THE LINER WAS STILL SEATED IN THE CUP AND WAS DIFFICULT TO R

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

  MAUDE report 11328138 ↗
• InjuryOct 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. REVISION NOTES STATED THAT THERE WAS SOME INSTABILITY WITH FLEXION AND INTERNAL ROTATION. PATIENT HAS PAIN PRIOR TO REVISION SURGERY. DOI: (B)(6) 2019 - DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 10652405 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A PAINFUL HIP. REMOVED TWO DOME SCREWS AND CHANGED HEAD & LINER. COULDN¿T SEE NUMBERS ON THE SCREWS. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2013, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10601824 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. DOI: UNKNOWN. DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN;

  Patient problems: No Code Available; Pain

  MAUDE report 9847626 ↗
• InjuryFeb 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS SEVERAL DISLOCATION. IMPLANTS WERE PUT IN APPROXIMATELY 11 TO 12 YEARS AGO. THE HEAD AND LINER EXCHANGE WAS PERFORMED. THE LETTERING WAS VERY FAINT/WORN OFF. DOI: 11 TO 12 YEARS AGO. DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9708718 ↗
• MalfunctionJan 6, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THERE WAS AN IMPLANT OF A CORAIL/PINNACLE LAST WEEK AND THE SURGEON MENTIONED THAT THE 32 +4MM NEUTRAL LINER THAT HE USED LOOKED DIFFERENT TO NORMAL. THE THEATRE SISTER THOUGHT NOTHING MORE OF IT AND THE CASE WENT WELL. LATER WHEN SHE SCANNED THE IMPLANTS INTO THEIR SYSTEM FOR NJR PURPOSES THE LINER WAS COMING UP AS A +4MM 10 DEGREE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553659 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY TO EXPLANT AN INFECTED DHS ON A (B)(6) YEARS OLD MALE. DEPUY PROSTALAC SYSTEM USED. DURING THE ACETABULAR IMPLANTATION OF A ALL POLY CUP WITH SIMPLEX CIMENT AND TOBRAMYCINE/ VANCOMYCINE PRODUCT CODE 1219-32-450, THE BLOOD PRESSURE OF THE PATIENT DROPPED AND THE SURGERY HAD TO BE POSTPONED UNTIL THE ANAESTHESIA TEAM WAS ABLE TO STABILIZE THE PATIENT. THE PATIENT WAS GETTING TRANSFUSIONS AND THE BLOOD LOSS BEFORE THE INCIDENT WAS AT ABOUT 2000ML. THE SURGEON CLOSED WITHOUT THE FEMORAL STEM AND HEAD. AFTER 1 HOUR, WE RESTARTED THE SURGERY TO COMPLETE IT. REDRAPING THE PATIENT. THE INSTRUMENT REMAINED IN THE ROOM DURING THE EMERGENCY BLOOD TRANSFUSION. SAME INSTRUMENTS WERE USED TO FINISH THE SURGERY. SURGEON IMPLANTED 3 CABLES (SYNTHES) A PROSTALAC STEM 1541-13-000 AND A 32MM HEAD 1365-22-000.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Not Applicable; Unspecified Infection

  MAUDE report 9504351 ↗
• InjuryOct 17, 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 EVACUATE A LARGE HEMATOMA FROM THE HIP. THERE WAS NO SIGN OF INFECTION. PATIENT WAS TRANSFUSED WITH TWO UNITS OF BLOOD AFTERWARDS. FURTHER REVIEW OF MEDICAL RECORDS INDICATE THAT THE ELEVATED METAL IONS PERSISTED WELL AFTER THE FIRST REVISION. STEM WAS REPORTED IN (B)(4) (1ST REVISION). DOI: (B)(6) 2010; DOE: (B)(6) 2010; (LEFT HIP).

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 9203675 ↗
• InjurySep 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2013, DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8976692 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP THAT WAS UNSTABLE AND PAINFUL. DOI: (B)(6) 2019. DOR: AUG 7, 2019. LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8941805 ↗
• InjuryAug 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LINER DISLOCATION PINNACLE CUP. IF OTHER, DESCRIBE: HAPPENED AFTER 10 MONTH IMPLANTED, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO.

  Patient problems: No Code Available

  MAUDE report 8934612 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: (B)(6). ADVERSE EVENT: FOOT DROP. ADVERSE EVENT DATE: (B)(6) 2015. DATE OF ONSET: (B)(6) 2015. DATE OF ACTION TAKEN: N/A. RELATIONSHIP TO THE STUDY DEVICE: NO RELATIONSHIP. RELATIONSHIP TO THE STUDY PROCEDURE: DEFINITE. FINAL OUTCOME: ONGOING. RANDOMIZED TO: TRILOCK SHORT STEM. TYPE OF RE-OPERATION: NO RE-OPERATION. ACTION TAKEN: NONE.

  Patient problems: No Code Available

  MAUDE report 8897415 ↗
• MalfunctionJun 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 50 +4 NEUTRAL MARATHON LINER DID NOT SEAT IN A 50 SECTOR POROCOAT CUP (121722050 LOT J3167Y) CORRECTLY AND WAS DREAMED DEFECTIVE AND WAS NOT IMPLANTED. SCREW WERE USED WITH THE CUP AND WAS DETERMINED THAT EACH SCREW WAS SEATED IN THE CUP CORRECTLY. THE CUP WAS DETERMINED TO BE DEFECTIVE AND WAS NOT IMPLANTED. A NEW 50 +4 NEUTRAL MARATHON LINER WAS IMPLANTED AND SEATED CORRECTLY. THE DEFECTIVE LINER WAS THROWN IN THE TRASH AND WILL NOT BE RETURNING. LOT NUMBER HAS BEEN REFERENCED FOR THE RECORDED. WITH 30 SECONDS SURGICAL DELAY. DOE: (B)(6) 2019; UNKNOWN HIP.

  Patient problems: Not Applicable

  MAUDE report 8723592 ↗