PINNACLE 1218-40-662Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295012184), received between Jun 30, 2017 and May 15, 2025 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED HER HIP POST REVISION THA WITH CONSTRAINED LINER. A HEAD AND LINER EXCHANGE WAS PERFORMED WITHOUT DELAY NOR PATIENT HARM. THE SURGEON CHOSE TO TRY A 10 DEG CONSTRAINED LINER IN HOPES THAT SHE WILL BE LESS LIKELY TO DISLOCATE. TRIALING ONCE AGAIN SHOWED EXCELLENT RANGE OF MOTION AND STABILITY WITH MINIMAL IMPINGEMENT. SURGEON STATES PATIENT HAS BEEN NON-COMPLIANT OF HIP PRECAUTIONS, DOING MOVEMENTS THAT SHOULD NOT BE ATTEMPTED AFTER SUCH EXTREME REVISION ARTHROPLASTIES WITH MINIMAL SOFT TISSUES PRESENT TO KEEP HER HIP IN PLACE. HE INTENDS TO CONTINUE TO INSTRUCT AND EDUCATE HER OF HER HIGH RISK OF DISLOCATION, EVEN WITH WELL ALIGNED COMPONENTS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22030588 ↗
• InjuryMay 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS A LEFT TOTAL HIP THAT IS A CONTINUOUS DISLOCATOR. PATIENT DISLOCATED OVER A HUNDRED TIMES. THIS TIME THE PATIENT DISLOCATED HER FEMORAL HEAD OUT OF THE CONSTRAINED LINER. THE PINNACLE REVISION CUP AND RECLAIM STEM ARE WELL FIXED AND RETAINED. THE SURGEON DID A LINER AND HEAD EXCHANGE WITH A CONSTRAINED CONSTRUCT AGAIN WITH A LONGER HEAD LENGTH. THE LINER WAS STILL INTACT IN THE CUP, AND THE RING WAS STILL AROUND THE LINER. THE HEAD WAS STILL ABLE TO DISLOCATE OUT OF THE LINER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22001707 ↗
• InjuryAug 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED. CEMENTED IN DUAL MOBILITY AND WENT UP IN HEAD LENGTH. DOI- (B)(6), 2024 DOR (B)(6) 2024 AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20086974 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, HEAD AND LINER WERE EXCHANGED. DOI: UNKNOWN. DOR: (B)(6), 2024. AFFECTED SIDE : LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19326161 ↗
• InjuryFeb 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. THIS PATIENT HAD HIS HIP REVISED SOMETIME AGO BY THE SURGEON. THE PATIENT HAS A 7 HIGH SUMMIT STEM, A 62MM PINNACLE CUP , A CONSTRAINED LINER, AND A 40MM +12 HIP BALL. THE CAT # AND LOT # FOR THE STEM, PINNACLE CUP, AND CONSTRAINED LINER ARE UNKNOWN. THE DATE OF THE REVISION IS UNKNOWN. THE PATIENT HAD DISLOCATED AND SURGEON DID AN OPEN REDUCTION WHERE THE 40MM +12 HIP BALL AND CONSTRAINED LINER WERE EXPLANTED AND REPLACED WITH A NEW FEMORAL HEAD AND CONSTRAINED LINER AND THE HIP WAS REDUCED. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: LEFT HIP

  Patient problems: Joint Dislocation

  MAUDE report 16413846 ↗
• InjuryNov 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT HAS A RIGHT TOTAL HIP THAT IS DISLOCATING. THE PATIENT HAS A CURRENT CONSTRAINED CONSTRUCT THAT HAS DISLOCATED. THE LOCKING RING IS STILL IN PLACE, BUT THE HEAD WAS STILL ABLE TO DISLOCATE FROM THE LINER. THE SURGEON THOUGHT HE WOULD TRY A DUAL MOBILITY AS A LAST RESORT. DOI: (B)(6), 2021, DOR: (B)(6), 2021, (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 12852163 ↗
• InjuryAug 20, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  SURGEON REVISED A TOTAL HIP REPLACEMENT AFTER THE PATIENT HAD A FALL AND DISLOCATED HIS HIP. THE LINER WAS CONSTRAINED AND HAD BROKEN INSITU. WHEN SURGEON WAS TRYING TO PUT THE METAL REINFORCEMENT RING OVER THE CONSTRAINED POLY, IT CRACKED. HE REMOVED IT AND HAD TO USE ANOTHER ONE. DOI: UNKNOWN. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 12347507 ↗
• MalfunctionJan 27, 2020Fracture; Fracture

  PINNACLE CONSTRAINED LINERS BROKE WHILE TRYING TO RELOCATE THE HIP.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9633536 ↗
• MalfunctionJun 20, 2019Fracture; Fracture

  CONSTRAINED LINER BROKE WHILE THE SURGEON WAS TRYING TO GET THE FEMORAL HEAD IN THE LINER.

  Patient problems: Not Applicable

  MAUDE report 8717599 ↗
• InjuryDec 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES CONSTRAINED LINER, DISLOCATION WITH OPEN REDUCTION, DISLOCATION WITH CLOSED REDUCTION AND ELEVATED METAL IONS AFTER FIRST REVISION.

  Patient problems: Joint Dislocation; Test Result

  MAUDE report 8173811 ↗
• InjuryJan 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2017. DOR: (B)(6) 2017. RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7185725 ↗
• InjuryJun 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF ALLEGES ELEVATED METAL IONS AND ABDUCTOR MUSCLE REPAIR.

  Patient problems: Discomfort; Foreign Body Reaction; Host-Tissue Reaction; Inflammation; Loss of Range of Motion; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 6680695 ↗