PINNACLE 1218-36-756Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295012153), received between Jan 19, 2018 and Jan 6, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO BROKEN CONSTRAINED LINER, EXCHANGED FOR A NEW ONE OF THE SAME SIZE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23977600 ↗
• InjuryJan 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON REMOVED CONSTRAINED LINER AND REPLACED WITH DUAL MOBILITY. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21056796 ↗
• InjuryDec 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER WITH A DISLOCATED HIP PROSTHESIS, AS THE HEAD HAD ESCAPED THE CONSTRAINED LINER. PATIENT HAD THE LARGE MAJORITY OF THEIR PELVIS REMOVED DUE TO CANCER AND RELIES SOLELY ON A CONSTRAINED LINER FOR STABILITY. A NEW CONSTRAINED LINER AND HEAD FROM ANOTHER MANUFACTURER, MATCHING THE PROXIMAL FEMORAL REPLACEMENT, WERE REPLACED UNEVENTFULLY. NO PATIENT HARM NOR DELAY IS NOTED. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20845815 ↗
• InjuryApr 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF TOTAL HIP ARTHROPLASTY. SURGEON PULLED THE STEM, HEAD, AND LINER, THEN CHANGED THE VERSION IN THE FEMORAL STEM. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19127657 ↗
• InjuryOct 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17940704 ↗
• InjuryOct 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION AND LOOSENING OF THE LOCKING RING. DOI: (B)(6) 2015; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15539021 ↗
• InjuryMar 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE WAS UNKNOWN. THIS PATIENT HAD A HIP REPLACED ON (B)(6) 2020. THE PATIENT DISLOCATED HIS LEFT HIP BENDING OVER TENDING TO HIS DOG. THIS IS THE 2ND REVISION FOR THIS PATIENT FOR DISLOCATION. THE SURGEON REVISED THIS PATIENT'S HIP WHERE HE EXPLANTED THE FEMORAL HIP BALL AND CONSTRAINED LINER. IT DID TAKE 30 MINUTES TO GET THE PINNACLE CONSTRAINED LINER FREE FROM THE PINNACLE SECTOR CUP, THIS WILL BE NOTED BELOW IN THE DER. DURING THE REVISION, THE SURGEON STATED THAT IT APPEARED THE PINNACLE CONSTRAINED LINER FRACTURED AROUND THE RIM OF THE LINER WHERE THE OUTER LOCKING RING SITS. HE BELIEVES THIS IS HOW THE HIP BALL BECAME DISASSOCIATED WITH THE CONSTRAINED LINER. HE ATTEMPTED TO EXTRACT THE SROM STEM WITH THE GOAL OF OPTIMIZING STEM POSITIONS FOR STABILITY BUT WAS UNABLE TO GET THE STEM DISASSOCIATED WITH THE SROM SLEEVE. THE SROM SLEEVE, PINNACLE CUP WAS LEFT IN SITU AND A NEW FEMORAL HIP BALL AND CONSTRAINED LINER CONSTRUCT WAS IMPLANTED. THE HIP BALL AND CONSTRAINED LINER WERE SO DAMAGED WITH OSTEOTOMES UPON EXPLANTING. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP AFFECTED.

  Patient problems: Joint Dislocation

  MAUDE report 13710531 ↗
• InjuryJan 21, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE CONSTRAINED LINER BROKE, CUP LOCKING MECHANISM WAS WORN AND NEEDED TO BE REPLACED. CUP WAS REMOVED AND REPLACED WITH A MULTI-HOLE CUP AND PINNACLE DUAL MOBILITY. ORIGINAL SURGERY FOR THE CUP AND SCREWS WAS DONE (B)(6) 2013, HEAD WAS DONE (B)(6) 2020 AT THE FIRST HIP REV(PT FELL AND FOLDED OVER THE LIP ON HIS LINER) AND CONSTRAINED LINER WAS DONE (B)(6) 2020 (HE DISLOCATED FROM HIS PREVIOUS REV). NO SURGICAL DELAY. DOI: (B)(6) 2013 (CUP, SCREWS), DOI: (B)(6) 2020 (HEAD AND LINER), DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11207318 ↗
• InjuryOct 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATION AND HAD THE HEAD AND LINER REVISED TODAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10649775 ↗
• InjurySep 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD CUP REVISION WITH 40 HEAD AND LINER DUE TO MULTIPLE DISLOCATIONS. PATIENT WAS REVISED TO CONSTRAINED LINER ON (B)(6) 2020 DUE TO MULTIPLE DISLOCATIONS. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A DISLOCATED HIP, REVISED TO CONSTRAINED LINER WITH +12 HEAD ON (B)(6) 2020. IT IS NOTED PT HAS FREQUENT FALLS AND HAS AN ABUNDANCE OF SOFT TISSUE IN THE LOWER HALF OF THE BODY. DOI: (B)(6) 2020. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation; No Code Available

  MAUDE report 10594029 ↗
• InjuryJul 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED HER CONSTRAINED LINER. LINER WAS EXCHANGED WITH ANOTHER CONSTRAINED LINER. IMPLANT RECORDS FOR CURRENT IMPLANTS ARE NOT AVAILABLE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10353075 ↗
• InjuryMar 31, 2020Naturally Worn; Naturally Worn

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM, WITH PROXIMAL CEMENT LOOSENING BUT WELL FIXED DISTALLY. REVISION OPERATIVE NOTES REPORTED THAT THE STEM WAS GROSSLY LOOSE AND THERE WAS SIGNIFICANT TORN POLYETHYLENE DEBRIS IN THE HIP JOINT. DOI: (B)(6) 2016. DOR: (B)(6) 2017, RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9903653 ↗
• InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION AND MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES WALKING DIFFICULTY AND SIGNIFICANT PAIN AFTER THE FIRST REVISION. THERE WERE NO REVISION SURGERY NOTES REPORTED IN THE MEDICAL RECORDS. STEM HAS BEEN REPORTED ON (B)(4). DOI:(B)(6) 2009 (CUP,SCREW). DOI: (B)(6) 2019 (HEAD, LINER). DOR: NONE REPORTED. LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9776113 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. THERE WERE NO ALLEGATIONS REPORTED HOWEVER THE PATIENT WAS REVISED AND THE REASON FOR REVISION WAS NOT PROVIDED. DOI: (B)(6) 2017. DOR: (B)(6) 2018, (LEFT HIP, FIFTH REVISION).

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

  MAUDE report 9753105 ↗
• InjuryNov 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION AND ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2016; DOR: NONE REPORTED (LEFT HIP); PLEASE SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 9290655 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED HIP THAT LED TO A LINER SWAP DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8760260 ↗
• InjuryOct 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8005767 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGED INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7995962 ↗
• InjuryApr 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION ON CONSTRAINED LINER. IT ALSO STATES A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available; Not Applicable

  MAUDE report 7471891 ↗
• InjuryJan 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2015; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7206152 ↗