PINNACLE 1218-36-656Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295012122), received between Mar 28, 2018 and Jan 26, 2026 — classified as 33 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (22 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS LINER DISASSOCIATED FROM CUP. NOTHING BROKE. NEW LINER WAS IMPLANTED ALONG WITH A NEW HEAD BALL. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 24178769 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF CONSTRAINED LINER. DOI:(B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22108058 ↗
• InjuryOct 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THE METAL RING AROUND THE LINER BECAME LOOSE AND WAS CAUSING THE PATIENT PAIN. THE LINER WAS REMOVED AND REPLACED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 20384655 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S PINNACLE REVISION CUP AND CONSTRAINED LINER PARTIALLY PULLED OUT OF THE ACETABULUM. THE SURGEON REMOVED THE CONSTRAINED LINER, ACETABULAR CUP AND FIVE SCREWS. A NEW REVISION CUP AND DUAL MOBILITY LINER WERE PLACED.

  Patient problems: Insufficient Information

  MAUDE report 20003080 ↗
• InjuryFeb 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON DECIDED TO TAKE OUT LINER AND HEAD AND EXCHANGE FOR SOMETHING WITH MORE OFFSET. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18769278 ↗
• InjuryJan 16, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  REVISION OF A PINNACLE CONSTRAINED LINER. ON FRIDAY JANUARY 5, 2024, WE WERE CONTACTED BY THE ATTENDING PHYSICIAN REGARDING THE DISLOCATION OF A HIP/LINER REVISION TO BE DONE ON (B)(6) 2024. THE PATIENT HAD A PINNACLE CONSTRAINED LINER (1218-36-656, PIN LNR NEUT +4 36IDX56OD) WITH A 36MM CERAMIC HEAD BALL (1365-36-710) THAT HAD DISLOCATED. UPON REVIEW OF THE X-RAY, THE HEAD BALL WAS COMPLETELY OUT OF THE LINER. THE CONSTRAINED LOCKING RING WAS STILL FIRMLY ATTACHED TO THE LINER. THE REMOVAL OF THE LINER WAS SUCCESSFUL WITH DAMAGE TO THE LINER, A NEW LINER AND HEAD BALL WAS IMPLANTED WITHOUT INCIDENT.

  Patient problems: Joint Dislocation

  MAUDE report 18518206 ↗
• InjuryDec 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON STATED THAT PATIENT WAS INFECTED AND ELECTED TO CHANGE ALL COMPONENTS. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023; DOR- (B)(6) 2023; AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18341683 ↗
• InjuryNov 6, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT HAD WORN THE RIM OF THE CONSTRAINED LINER OFF AND DISLOCATED. PATIENT ALSO WORE A NOTCH IN THE NECK OF THE SUMMIT STEM. SURGEON REMOVED STEM, HEAD AND LINER AND PUT IN A DISTALLY FIXED STEM A NEW +4/10 DEGREE CONSTRAINED LINER AND A HEAD. SALES REP DID NOT HAVE THE RECORDS FOR THE STEM OR THE DATE OF THE ORIGINAL SURGERY. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18073433 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATION. CONSTRAINED LINED WAS REPLACED WITH A DUAL MOBILITY LINER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN DOR - (B)(6) 2023. AFFECTED SIDE - UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17689774 ↗
• InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CONSTRAINED LINER DISLOCATED. DOI: (B)(6) 2023 DOE:( B)(6) 2023 AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17606950 ↗
• InjuryJun 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. LINER WAS SWAPPED. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14841004 ↗
• InjuryFeb 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF ACETABULAR COMPONENTS AND FEMORAL HEADS FOR CONTINUOUS BILATERAL CHRONIC DISLOCATION RIGHT HIP. MOST RECENT DISLOCATION BELIEVED TO BE ASSOCIATED WITH A FALL.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 13600186 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THA PERFORMED YEARS AGO, ORIGINAL DATE UNKNOWN. REVISION COMPLETED DUE TO DISLOCATION. PATIENT WAS IMPLANTED WITH A CONSTRAINED LINER AND LONGER LENGTH ON THE HIP BALL. PATIENT RETURNED TO SURGEON WITH SUSPECTED INFECTION IN THE HIP. INFECTION WAS CONFIRMED AND SURGEON PERFORMED A THOROUGH WASHOUT OF THE JOINT AND CHANGED THE CONSTRAINED LINER AND FEMORAL HEAD. ORIGINAL IMPLANTS WERE IMPLANTED AFTER THE WASHOUT. SURGEON REDUCED THE HIP AND FOUND IT TO BE STABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13250563 ↗
• InjuryMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE REASON FOR REVISION IS DISLOCATION, WITH LINER AND HEAD EXCHANGE. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11886153 ↗
• InjuryApr 8, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY'S TIME WASN¿T EXTENDED.

  Patient problems: Joint Dislocation

  MAUDE report 11633933 ↗
• InjuryMar 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD CHRONIC DISLOCATOR OF LEFT HIP. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11562610 ↗
• InjuryJan 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED HIP. DOI: UNKNOWN; DOR: (B)(6) 2020: HIP UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11117285 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER AND HEAD WERE EXCHANGED DURING WASHOUT. WASHOUT WAS DUE TO INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10586677 ↗
• InjuryJul 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A RIGHT HIP REVISION DONE SOMEWHERE IN (B)(6) ABOUT 5 YEARS AGO. THE SURGEON PUT IN A CONSTRAINED LINER BECAUSE THE PATIENT WAS DISLOCATING. THE PATIENT SHOWED UP TO THE ER WITH A DISLOCATED HIP AND SURGEON SAID THE PATIENT HAD DISLOCATED WITH A CONSTRAINED LINER FROM THE X-RAY AND HE WANTED TO DO A NEW HEAD/LINER EXCHANGE. DURING THE SURGERY, THE SURGEON REMOVED THE METAL HEAD AND NOTICE THAT THERE WAS METAL DEBRIS, AND THE SURGEON THOUGHT THAT THIS PATIENT MIGHT HAVE BEEN DISLOCATED FOR AWHILE BECAUSE I GUESS THIS PATIENT ISN'T VERY MOBILE. THE SURGEON REMOVED THE LINER AND IMPLANTED THE SAME SIZE CONSTRAINED LINER AND CHOSE TO DO A CERAMIC HEAD OF THE SAME LENGTH. HE WAS HAPPY WITH THE STABILITY AND LEG LENGTHS DOI: 5 YEARS AGO; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10271155 ↗
• InjuryMay 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED THEIR CONSTRAINED LINER. TODAY THEY WERE CONVERTED TO A TRIPOLAR CONSTRUCT. DOI: (B)(6) 2017. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10053492 ↗
• MalfunctionMar 3, 2020Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WASTED PRODUCT 1218-36-656 AND 1365-36-710. SURGEON COULD NOT GET LOCKING RING TO SEAT. REMOVED RING, LINER, AND HEAD . INSERTED NEW LINER AND HEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780343 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, CLINICALLY INFECTED AND CYST ON RIGHT HIP INCISION AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THERE WERE NO NEW ALLEGATION REPORTED. DOI: (B)(6) 2017; DOR: NONE REPORTED (RIGHT HIP) SECOND ALLEGATION AFTER FIRST REVISION.

  Patient problems: Cyst(s); No Code Available; Pain; Unspecified Infection

  MAUDE report 9557789 ↗
• InjuryJan 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9557454 ↗
• MalfunctionNov 1, 2019Difficult to Insert; Inadequacy of Device Shape and/or Size; Fitting Problem; Difficult to Insert; Inadequacy of Device Shape and/or Size; Fitting Problem

  INTRAOPERATIVELY DURING REVISION SURGERY THE SURGEON HAD ISSUES WITH THE LINER´S METAL CONSTRAINING RING. CUP WAS EXPLANTED AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268760 ↗
• MalfunctionSep 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER REVISION THE SURGEON'S PLAN WAS TO CONVERT TO A CONSTRAINED LINER AND TS CERAMIC HEAD. REMOVED PRIMARY LINER AND HEAD. IMPLANTED CONSTRAINED LINER AND PUT ON 36+12 TS CERAMIC HEAD. WHILE DOCTOR WAS REDUCING THE HIP HE CRUSHED THE SIDE OF THE CONSTRAINED LINER. THE SURGEON THEN REMOVED THE LINER AND HEAD AGAIN. AND THEN IMPLANTED A NEW CONSTRAINED LINER AND A TS CERAMIC 36+8.5 HEAD. AFTER REDUCING THE PATIENT THEY RAN HIM THROUGH A RANGE OF MOTION WHERE THE LINER WAS PULLED FROM THE CUP. THEY TOOK EVERYTHING BACK OUT AND PUT IT BACK IN. THEY RAN HIM THROUGH A RANGE OF MOTION AGAIN AND THE LINER DISASSOCIATED FROM THE CUP AGAIN. AT THAT POINT WE TOOK EVERYTHING OUT AND IMPLANTED A 456X40 +4 10 DEGREE LINER WITH A 40 BIPOLAR HEAD. AFTER RUNNING EVERYTHING THROUGH A RANGE OF MOTION DOCTOR WAS HAPPY WITH STABILITY AND HE CLOSED UP. DOE: (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081843 ↗