PINNACLE 1219-32-254Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295014195), received between Dec 7, 2017 and Jun 26, 2025 — classified as 13 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS A DIFFICULTY SEATING A MARATHON LINER INTO A PINNACLE CUP. THE SURGEON COMMENTED THAT HE HAD GOOD EXPOSURE AND WAS ABLE TO VISUALIZE THE RIM OF THE CUP FULLY. UNFORTUNATELY, HE WAS UNABLE TO GET THIS PARTICULAR LINER TO SEAT INTO THE CUP. THIS CAUSED 15 MINUTES DELAY TO THE PROCEDURE. THERE WAS NO PATIENT IMPACT AS THEY CHANGED IT TO A DIFFERENT LINER AND THIS ONE WENT IN WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341985 ↗
• InjuryJan 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS LUXATION OF A PINNACLE LIPPED 54-32 LINER TWO WEEKS AFTER PLACEMENT. THE PATIENT INITIALLY UNDERWENT A TOTAL HIP AND HAD REVISION SURGERY TWO WEEKS AFTER THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21101982 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT OF CORAIL PINNACLE CONSTRUCT DUE TO INFECTION. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2023. IN ORDER TO COMPLETE THE WASHOUT AND DEBRIDEMENT, THE LINER AND HEAD WERE REMOVED AS PER IMPACTED PRODUCTS. A NEW LINER AND REVISION HEAD WERE THEN IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17916505 ↗
• InjuryJun 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION TOTAL HIP REPLACEMENT FOR INSTABILITY DISLOCATION. PRIMARY PROCEDURE BELIEVED TO PRE 2010 AT HOSPITAL. DATE UNKNOWN AND CANNOT BE SOURCED. REVISION TOTAL HIP REPLACEMENT IN 2012 (APPROXIMATE YEAR DATE UNKNOWN AND CANNOT BE SOURCED) HOSPITAL FOR MID SHAFT FEMORAL FRACTURE ALSO (PERI PROSTHETIC FRACTURE). NO COMPONENTS BELIEVE TO HAVE BEEN CHANGED DUE TO REPAIR OF THE FRACTURED FEMUR WHICH WAS REPAIRED USING A LONG BONE PLATE AND SCREWS. NO FURTHER INFORMATION IS AVAILABLE REGARDING ANY PREVIOUS PROCEDURE. THIS HAS BEEN SOUGHT BUT IS UNABLE TO BE SOURCED. NO PATIENT OR SURGEON CONSENT HAS BE GAINED FOR THE SHARING OF INFORMATION INCLUDING THAT APPEARING ON THIS DOCUMENT. PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP-01750635. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01750636. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01750637. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01750638. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01750639. DEVICE PROPERTY OF NO

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17151306 ↗
• MalfunctionJan 30, 2023Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Defective Device; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Defective Device

  THEY OPENED THE FIRST LAYER OF THE PACKAGE BEFORE OPENING THE STERILE PART, THE NURSE NOTICED SOMETHING STRANGE WITH THE IMPLANT. AFTER CONSULTING WITH SURGENT, DECISION WAS MADE TO OPEN ANOTHER PACKAGE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264353 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  RIGHT HIP WASHOUT, HEAD AND POLY EXCHANGE FOR INFECTION. ORIGINAL SURGERY WAS ON (B)(6) 2010. NO SURGICAL DELAY,

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

  MAUDE report 11338326 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF CORAIL STEM & LINERS FOR INFECTION. WASHOUT CONDUCTED AND IMPLANTS, NEW IMPLANTS REPLACED.

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

  MAUDE report 10958824 ↗
• InjuryOct 23, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THE SURGEON NOTED PLACING A CONSTRAINED LINER DUE TO MULTIPLE DISLOCATIONS FOLLOWING THE FIRST REVISION.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Edema; Foreign Body Reaction; Inflammation; Joint Dislocation; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10727283 ↗
• InjuryJul 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE IS THE RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available; Tissue Damage

  MAUDE report 10351438 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS LOGGED TO CAPTURE THE FIRST REVISION MENTIONED ON PC-(B)(4). THE FIRST REVISION WAS DONE ON THE (B)(6) 2019 WHICH A POLY LINER AND HEAD WERE REPLACED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9675920 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION THR: (B)(6) PRIVATE HOSPITAL, (B)(6) 2020. PRIMARY IMPLANT DATE: (B)(6) 2018. REVISION HIP FOR AN INFECTION. ALL COMPONENTS REMOVED, PROSTALAC STEM AND CUP INSERTED. USED A SMALLER SIZED SHIM WITHIN THE SAME THICKNESS. THIS IS THE SECOND REVISION FOR THIS PATIENT. THE FIRST REVISION WAS DONE ON THE (B)(6) 2019 WHICH A POLY LINER AND HEAD WERE REPLACED (B)(4)). NO AE REPORTED, NO DELAY IN THE SURGERY.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9624857 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED HER PRIMARY TOTAL HIP IN 2017. REVISED TODAY DUE TO THE PATIENT BEING UNHAPPY WITH A LEG LENGTH DISCREPANCY. PAIN, IRRITATION WITH LEG LENGTH DISCREPANCY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 9490567 ↗
• MalfunctionDec 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  COULDN'T USE PRODUCT ORIGINALLY TAKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8154826 ↗
• InjuryOct 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACETABULAR CUP REVISION DUE TO RECURRENT DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 7953728 ↗
• InjuryJul 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEAD AND LINER CHANGE FOR AN INFECTED HIP, (B)(6) HEALTH (B)(6) 2018. PRIMARY HIP REPLACEMENT (B)(6) 2018. HEAD AND LINER CHANGE ON INFECTED HIP, NO DAMAGE TO IMPLANTS NOTED. (B)(6)REPRESENTATIVE WAS PRESENT AT THE CASE. PATIENT INITIAL (B)(6), AGED (B)(6) YEARS, DOB: (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 7700008 ↗
• InjuryDec 7, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS HIP DISLOCATION. IT WAS REPORTED THAT SURGEON REMOVED CUP, LINER AND HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 7095460 ↗