PINNACLE 1219-32-256Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295014201), received between Sep 14, 2017 and Feb 11, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 21355069 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LOOSE STEM AND ACETABULAR IMPLANTS DUE TO SUSPECTED INFECTION, ALL IMPLANTS REMOVED AND TEMPORARY CEMENT SPACER IMPLANTED, THIS WILL STAY IN PLACE UNTIL INFECTION HAS BEEN TREATED, SECOND STAGE REVISION WILL THEN TAKE PLACE. PRIMARY OPERATION WAS DONE ON (B)(6) 2021. DOR: (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 16367317 ↗
• MalfunctionJun 9, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER DID NOT ENGAGE WITH SHELL AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14647443 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SURGEON DIDN¿T COMMENT ON CUP LOOSENING DURING THE REVISION.

  Patient problems: Pain

  MAUDE report 12858517 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIP REVISION: HEAD AND LINER EXCHANGE DUE TO INFECTION. THE PATIENT HAD OOZE COMING OUT OF THE LEFT SIDE WHERE THEY HAD A HIP REPLACEMENT. (ORIGINAL PRIMARY HIP PROCEDURE DATE WAS (B)(6) 2021). THE SURGEON WASHED OUT THE WOUND AND CHANGED THE FEMORAL HEAD, AND MARATHON LINER. AND THEN CLOSED THE WOUND. IT IS BELIEVED THE INFECTION IS NOT DUE TO THE IMPLANTS. AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

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

  MAUDE report 12151024 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF PRIMARY COMPONENTS. COMPONENTS WERE REMOVED DUE TO INFECTION.

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

  MAUDE report 11605643 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP REVISION; PRIMARY IMPLANT DATE: (B)(6) 2016. REASON FOR REVISION: PAIN, LEG LENGTH INEQUALITY. RELEVANT PATIENT PRE-EXISTING CONDITIONS/ COMORBIDITIES; RIGHT HIP REPLACEMENT INSITU. PATIENT ACTIVITY LEVELS; AMBULANT. MG UNKNOWN JRN: PINNACLE CUP 56MM, PINNACLE LINER 56 OD 32ID, CERAMIC HEAD 32+5, CORAIL STEM KA10.

  Patient problems: No Code Available; Pain

  MAUDE report 8436008 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION AFTER THE FIRST REVISION. DOI: (B)(6) 2007; DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 8132603 ↗
• InjuryJan 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISLOCATING LEFT TOTAL HIP ORIGINAL DOS (B)(6) 2006 (B)(6). PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION:PT NEEDED REVISION SURGERY HEAD AND LINER EXCHANGE IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Joint Dislocation

  MAUDE report 7191170 ↗
• InjuryJan 12, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR. DOI: (B)(4) 2005; DOR: (B)(6) 2017; LEFT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185616 ↗
• InjurySep 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NECK OF THE PROSTHESES IS BROKEN 9 YEARS AFTER IMPLANTATION . LUXATION OF THE HIP. NECK FRACTURE OF THE PROSTHESES. REVISION IS PLANNED ON MONDAY (B)(6) 2016. 2007 FIRST SURGERY AFTER 4 YEARS CHANGE FROM CERAMIC LINER TO POLY LINER. UPDATE 27 JUL 2017: EMAIL NOTIFICATION FROM STEVE BACKHOUSE RECEIVED. THERE IS NO NEW INFORMATION ADDED. THIS COMPLAINT WAS UPDATE ON: AUG 15, 2017. UPDATE AUG 15, 2017: ADDITIONAL INFORMATION RECEIVED. UPDATED THE CUP PRODUCT. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: AUG 18, 2017.

  Patient problems: Joint Dislocation

  MAUDE report 6864771 ↗