PINNACLE 1218-40-762Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295012221), received between Jul 21, 2017 and May 7, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNFORTUNATELY DISLOCATED HER HIP AGAIN POST REV THA. HEAD AND LINER WERE EXCHANGED WITHOUT DELAY AND NO PATIENT HARM IS NOTED. ALL COMPONENTS WERE WELL FIXED AND WELL FUNCTIONING SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. ROM WAS ONCE AGAIN FOUND TO BE EXCELLENT SHOWING NO DISLOCATION OPERATIVELY EVEN IN EXTREME ROM TESTS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25116085 ↗
• InjuryApr 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH DISLOCATED HIP POST COMPLEX REVISION THA. EXISTING CONSTRAINED LINER AND HEAD WERE REMOVED WITHOUT DELAY NOR PATIENT HARM AND NEW COMPONENTS WERE PLACED. PATIENT WAS AGAIN FOUND TO BE EXTREMELY STABLE IN ALL ROM POSITIONS ONCE THE SAME NEW COMPONENTS ARE PLACED. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24971410 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS INFECTED. ALL COMPONENTS WERE REMOVED. PATIENT HAS MULTIPLE SURGERY DATES, (B)(6) 2020. (B)(6) 2022. (B)(6) 2025. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22176837 ↗
• InjuryJul 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HIP DISLOCATION. STEM, HEAD, AND LINER WERE REMOVED AND REPLACED WITH DEPUY LINER. STEM AND HEAD WERE REPLACED WITH COMPETITOR'S IMPLANTS. NO LOSS OF TIME. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19701878 ↗
• InjurySep 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO HEAD DISLOCATED FROM CONSTRAINED LINER. LOCKING RING WAS INTACT AND FULL SEATED ON LINER. DOI: (B)(6) 2018. DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12413411 ↗
• InjuryMay 20, 2020Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED THAT THE AFFECTED SIDE WAS LEFT AND THIS EVENT HAPPENED DURING REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 10075131 ↗
• MalfunctionJan 27, 2020Fracture; Fracture

  PINNACLE CONSTRAINED LINERS BROKE WHILE TRYING TO RELOCATE THE HIP.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9633535 ↗
• InjurySep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED BECAUSE HE EXPERIENCED A TRAUMATIC FALL, WHICH CAUSED THE CUP TO SHIFT INTO AN UNFAVORABLE POSITION, RESULTING IN DISLOCATION. DOI: (B)(6) 2010 - DOR: (B)(6) 2010, (RIGHT HIP). UPDATE 12/21/2010 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, STROKE, HEART ATTACK, BONE FRACTURE, ABDUCTOR MUSCLE REPAIR, DISLOCATION, INFECTION, AND ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: (B)(6) 2010, (RIGHT HIP); DOI: (B)(6) 2007, (STEM). THIS PC IS FOR THE SECOND REVISION OF THE RIGHT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Cardiac Arrest; Hypersensitivity/Allergic reaction; Infarction, Cerebral; Joint Dislocation; No Code Available; Tissue Damage; Unspecified Infection

  MAUDE report 9075486 ↗
• MalfunctionNov 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE SURGEON WAS NOT ABLE TO INSTALL THE RING OVER THE CONSTRAINED LINER INTERPRETABLY. IT WAS INDICATED THAT THE SURGEON ENDED UP CUTTING THE RING AND NOT IMPLANTING.

  Patient problems: No Information; Not Applicable

  MAUDE report 7016935 ↗
• InjuryJul 21, 2017Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS HIP DISLOCATION. IT WAS STATED THAT HIS HIP BROKE WHICH IMPLANTED THE SAME SURGEON ON THE SAME HOSPITAL. THE PATIENT'S INITIAL PINNACLE 62MM OD X 40MM ID +4 10 DEGREE CONSTRAINED LINER WAS REPLACED WITH A PINNACLE 62MM OD X 40MM ID +4 NEUTRAL CONSTRAINED LINER. THE INITIAL 40MM +5 BIOLOX DELTA TS FEMORAL HEAD WAS ALSO REPLACED WITH A MATCHING 40MM +5 BIOLOX DELTA TS FEMORAL HEAD. UPDATE JUL 19, 2017: ADDITIONAL INFORMATION. THAT THE PATIENT HAD A FRACTURED CONSTRAINED LINER. THIS COMPLAINT WAS UPDATED ON JUL 19, 2017.

  Patient problems: Joint Dislocation

  MAUDE report 6731195 ↗