PINNACLE 1219-36-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10603295014577), received between May 1, 2015 and Feb 9, 2026 — classified as 52 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 59 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Naturally Worn

  PATIENT WAS REVISED DUE TO HEAD AND LINER EXCHANGE FOR POLY WEAR. SURGEON REPORTED THAT PATIENT WAS IN PAIN AND HAD LIMITED RANGE OF MOTION. UPON EXPLANT, SIGNIFICANT POLY WEAR WAS EXPERIENCED. THERE WAS TRANSFER DEBRIS ON THE HEAD FROM ARTICULATING IN THE CUP (WAS BLACK). NEW LINER WAS SEATED INTO CUP ADEQUATELY. NEW HEAD WAS IMPLANTED. DOI: (B)(6) 2011. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24291250 ↗
• InjuryNov 20, 2025Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: ¿ CAN YOU PLEASE CONFIRM IF THE PATIENT HAD PREVIOUS REVISION FOR REMOVAL OF DEPUY STEM? ¿ WHAT WAS THE REASON FOR REVISION FOR THE PREVIOUS REVISION? ¿ WAS IT REPORTED? IF YES, PLEASE SHARE THE PC NUMBER. ¿ PRODUCT DETAILS OF THE REMOVED DEPUY STEM? ¿ WHEN WAS THE REVISION? "I¿M SORRY BUT I DON¿T HAVE ALL THE DETAILS YOU ARE REQUESTING. FROM WHAT I REMEMBER THIS WAS POSSIBLY AN ASR METAL ON METAL CASE AND THE STEM WAS POSSIBLY A CORAIL, STILL USES CORAIL AS HIS HIP STEM PREFERENCE. I DON¿T KNOW THE ORIGINAL REASON FOR REVISION, BUT I DO KNOW 2 OF THE HIP REVISIONS WERE FOR ABDUCTOR REPAIR/RECONSTRUCTION WHICH COULD HAVE POSSIBLY LED TO INFECTION. I WOULD ASSUME THE ASR LINER WAS REMOVED WHEN THE STEM WAS. I DO NOT KNOW IF THESE PRODUCTS WERE REPORTED. UNSURE OF ANY DATES."

  Patient problems: Pain

  MAUDE report 23605714 ↗
• MalfunctionSep 8, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE HIP SURGERY, THE CERAMIC LINER FULLY ADHERED TO THE ACETABULAR SHELL, BUT WHEN IMPLANTING THE ACETABULAR CERAMIC LINER, IT WAS FOUND THAT THE CERAMIC LINER DID NOT FULLY MATE WITH THE ACETABULAR SHELL. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22996293 ↗
• InjuryAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A LEFT HIP DISLOCATION. A CLOSED REDUCTION TECHNIQUE WAS PERFORMED TO RESOLVE IT. DOE: (B)(6) 2012, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22730346 ↗
• InjuryAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A LEFT HIP DISLOCATION UPON GETTING OFF TOILET STOOL. A CLOSED REDUCTION TECHNIQUE WAS PERFORMED TO RESOLVE IT. DOI: (B)(6) 2012, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22729966 ↗
• InjuryDec 13, 2024Fracture; Fracture

  IT WAS REPORTED BREAKAGE OF A PINNACLE INSERT IMPLANTED APPROXIMATELY FIVE YEARS AGO. ADDITIONALLY, NO REVISION SURGERY DATES HAVE BEEN COMMUNICATED.

  Patient problems: Insufficient Information

  MAUDE report 20929141 ↗
• MalfunctionMay 14, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE SURGERY, THE LINER WAS DEFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309410 ↗
• InjuryApr 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HIP IS DISLOCATING. SURGEON RETAINED SUMMIT STEM AND 52 PINNACLE CUP. SURGEON CONVERTED PATIENT TO PINNACLE DUAL MOBILITY. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19191172 ↗
• InjuryApr 25, 2024Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED: A. CAN YOU PLEASE CONFIRM IF ANY DEPUY HEAD WAS REVISED OR USED IN PATIENT? AS CAN BE SEEN FROM THE X-RAY, PT DEPUY CORAIL HAD A PROSTHESIS WITH AN ASSOCIATED METAL HEAD. AT OUR REOPERATION, THIS WAS REPLACED WITH A NEW DEPUY CORAIL HEAD ON THE EXISTING CORAIL PROSTHESIS. B. PLEASE PROVIDE THE PRODUCT DETAILS OF HEAD? DEPUY CORAIL HEAD (WHICH I REMEMBER SENT TOGETHER WITH THE DAMAGED LINER AND CUP). SIZE CANNOT BE SPECIFIED FROM HERE. C. PLEASE SPECIFY THE PATIENT SYMPTOMS? AS PREVIOUSLY WRITTEN, WELL-FUNCTIONING HIP, UNTIL 2024, WHEN A MECHANICAL SCRAPING SENSATION IS FELT IN THE HIP.

  Patient problems: Insufficient Information

  MAUDE report 19179931 ↗
• InjuryMar 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT THERE HAS BEEN AN INCIDENT WITH A PINNACLE THA ACETABULUM CUP. SHORTLY AFTER A SENSE OF THE KNEE, CLICK AND INSTABILITY OF THE HIP. RE-OPERATION SHOWS BROKEN PLASTIC LINER. DOI: (B)(6) 2022. DOE: (B)(6) 2024.

  Patient problems: Joint Laxity

  MAUDE report 18988187 ↗
• InjuryOct 5, 2023Naturally Worn; Naturally Worn

  (B)(4): THE MEDICINES AGENCY HAS BEEN INFORMED BY HOSPITAL OF AN INCIDENT WITH PINNACLE CUP. WORN LINER IN THE HIP PROSTHESIS, INSERTED 12 NOV 2015 FOUND WORN OUT ON NEW OPERATION (B)(6) 2020. DOI: (B)(6) 2015. DOE: (B)(6) 2020. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 17876519 ↗
• MalfunctionMay 3, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  LINER DEFORMED. IT WAS REPORTED THAT DURING THE SURGERY, NOTED THE LINER WAS DEFORMED WITH OVAL SHAPE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862714 ↗
• MalfunctionMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THE INCIDENCE OF A PATIENT OPERATED 6 MONTHS AGO OF PTM WITH PINNACLE CUP, WHICH WAS DEFORMED WHEN REMOVED IN A SECOND SURGERY. THE PATIENT IS REINTERVENED WITH A REVISION CUP.

  Patient problems: Insufficient Information

  MAUDE report 16528476 ↗
• InjuryMar 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT UNDERWENT PRIMARY RIGHT TOTAL HIP REPLACEMENT, CORAIL/PINNACLE APPROX 3 YEARS AGO. PATIENT HAS BEEN HAVING RECURRENT FALLS AND DISLOCATIONS, SURGEON STATES RELATED TO HIS ONGOING PARKINSONS DISEASE PROGRESSION. PROCEDURE TODAY REVISION OF RIGHT THR, REMOVAL OF LINER AND CHANGE TO CONSTRAINED LINER AND FEMORAL HEAD CHANGE. DOI: (B)(6) 2019. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16460106 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED STAGE 1 OF A 2-STAGE RIGHT HIP REVISION TO TREAT PAIN, INFLAMMATION, AND INFECTION. ALL DEVICES WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DO1: 2012. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 15917679 ↗
• InjurySep 26, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE REP THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO A CUP AND LINER FAILURE. INITIAL IMPLANT ON (B)(6) 2018. NO OTHER DETAILS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15485779 ↗
• InjurySep 19, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  COMPLAINT REFERENCE TO (B)(4). REVISION SURGERY. PHYSICIAN REPORTED METALLOSIS. PHYSICIAN USED ANOTHER ONE COMPANY PRODUCT TO PROCEDURE COMPLETED. AFTER SOME TIME JUST BEFORE THE REVISION THE HEAD AND THE CUP WERE ARTICULATING TOGETHER ON A SMALL SPACE WHERE THE LINER WAS MOST BADLY DAMAGED. THE CERAMIC HEAD DID NOT HAVE THE TS SLEEVE, DURING THE FIRST REVISION THE CONUS OF THE STEM WAS NOT DAMAGED. DOI: (B)(6) 2022; DOR: (B)(6) 2022; UNKNOWN HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 15446269 ↗
• InjuryJun 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PINNACLE HEAD AND LINER WERE REMOVED FROM DISLOCATED HIP SO A CONSTRAINED LINER AND NEW HEAD WERE IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2022, UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14575788 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: UNK . DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 14472611 ↗
• InjuryMar 17, 2022Naturally Worn; Naturally Worn

  PATIENT COMPLAINED OF HIP PAIN FOLLOW THA. UPON REVIEWING FILMS, DOCTOR FELT PATIENT HAD SOME POLY WEAR AND REQUIRED REPLACEMENT. A DUAL MOBILITY WAS IMPLANTED FOR GREATER STABILITY AND LEG LENGTH. DOI: (B)(6) 2009, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP AFFECTED.

  Patient problems: Joint Laxity; Pain; Physical Asymmetry

  MAUDE report 13801318 ↗
• InjuryFeb 15, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  REVISION SURGERY WAS COMPLETED DUE TO UNSPECIFIED ISSUE WITH MATERIALS. DOI: (B)(6) 2015. DOR: UNKNOWN. AFFECTED SIDE UNKNOWN.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 13539152 ↗
• InjuryDec 28, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH METALOSIS FROM POLY WEAR FAILURE AND THE FEMORAL HEAD RUBBING AGAINST THE CUP. THE HEAD, LINER, AND CUP WERE ALL REMOVED. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: 2012, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 13094475 ↗
• InjuryNov 17, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE HEAD AND LINER WAS WORN OVER TIME. A NEW HEAD AND LINER WAS REPLACED. DOI: (B)(6) 2009. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12828549 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT FELL ON RT HIP (B)(6) 2021 AND DEVELOPED LT HIP PAIN. PT UNDERWENT REVISION OF LT ACETABULUM. ORIGINAL LT TOTAL HIP (B)(6) 2014. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Fall; Pain

  MAUDE report 12469406 ↗
• InjuryJun 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY DURING THE REVISION SURGERY.

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

  MAUDE report 11920705 ↗