PINNACLE 1219-28-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295013273), received between Dec 3, 2017 and Feb 8, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? A. NO DELAY. B. WAS/WERE THERE ANY PATIENT CONSEQUENCE/S RELATED TO THE EVENT? B. PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18668055 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS EXPERIENCED PROXIMAL FEMORAL LOSS AND HAS BECOME UNSTABLE. ACCORDING TO THE SURGEON HER IMPLANTS ARE STILL VERY WELL FIXED, HOWEVER THE ACETABULUM IS A 46MM PINNACLE BANTAM CUP. HE WOULD LIKE TO REPLACE THE PRIMARY POLYETHYLENE LINER WITH A CONSTRAINED LINER TO AID WITH THIS PATIENT'S STABILITY. UNFORTUNATELY THE BANTAM CUP REQUIRES A BESPOKE CONSTRAINED LINER IMPLANT TO BE MANUFACTURED. THE SURGEON HAS COMPLETED THE DEVICE REQUEST FORM WITH ALL PARTS COMPLETED. PATIENT HAS BEEN GIVEN THE SPECIFIC CONSENT FORM RELATED TO THE MANUFACTURE OF THIS BESPOKE CONSTRAINED LINER DOI: (B)(6) 2018. DOE: (B)(6) 2023. AFFECTED SIDE:

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17389642 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED HIP. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. THE ACETABULAR CUP WAS LOOSE. LOOSENING INTERFACE WAS NON-CEMENTED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15819645 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 14371731 ↗
• InjuryFeb 28, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO LINER DISASSOCIATING FROM THE CUP. WHEN IT WAS REMOVED IT WAS OBSERVED THERE WAS ONLY ONE TAB REMAINED THE ON LINER. LINER AND FEMORAL HEAD WERE EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 13619214 ↗
• InjuryAug 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD RE-OCCURRENCE DISLOCATION. DS ACETABULAR CUP/LINER WAS EXPLANTED, FEMORAL HEAD REMOVED, THEN A COMPETITOR MDM CONSTRUCT IMPLANTED ALONG WITH A DS 22 MM FEMORAL HEAD. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10437254 ↗
• InjuryApr 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HEAD AND LINER EXCHANGE DUE TO DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9963113 ↗
• InjuryDec 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DESCRIPTION OF THE INCIDENT: ONE MONTH AFTER THE PATIENT HAD A THA, THE HIP WAS LUXATED. THE LINER HAD LOOSEN FROM THE METAL CUP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 9483755 ↗
• InjuryNov 8, 2018Fracture; Material Separation; Naturally Worn; Fracture; Material Separation; Naturally Worn

  PATIENT WAS REVISED DUE TO PAIN AND WEAR.

  Patient problems: No Code Available; Pain

  MAUDE report 8051147 ↗
• InjuryJun 6, 2018Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated

  REVISION OF HIP INLAY BECAUSE OF CUP AND LINER DISASSOCIATION.

  Patient problems: Injury; Not Applicable

  MAUDE report 7573357 ↗
• InjuryFeb 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IMPLANT HAD TO BE REVISED DUE TO LUXATION BETWEEN CUP AND LINER. DOI: UNKNOWN ; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7285509 ↗
• InjuryJan 16, 2018Disassembly; Naturally Worn; Disassembly; Naturally Worn

  DISLOCATION OF INLAY RIGHT SIDE. DOI (B)(6) 2011, DOR (B)(6) 2017; RIGHT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7193881 ↗
• InjuryDec 3, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT FELL AND DISLOCATED HER HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 7078090 ↗