PINNACLE 1219-32-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295013945), received between Jul 9, 2018 and May 12, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A C-STEM PINNACLE CONSTRUCT DUE TO PERIPROSTHETIC FRACTURE. UPON EXPOSURE IT WAS DETERMINED THAT THE SITE WAS INFECTED TOO. PERFORMED A TWO STAGE REVISION. THE FEMUR WAS FRACTURED INTO ABOUT 6 FRAGMENTS. ALL COMPONENTS WERE REMOVED (STEM, CUP, LINER, AND HEAD). THE FEMUR WAS CABLED BACK UP AND A RECLAIM PINNACLE DUAL MOBILITY CONSTRUCT WAS IMPLANTED. UNABLE TO PROVIDE ANY LOT NUMBER.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 16920968 ↗
• InjuryMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO HIP DISLOCATION. DOI: (B)(6) 2003, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13860374 ↗
• InjuryFeb 15, 2021Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  SURGEON IS REPORTING A DISASSOCIATION OF INLAY FROM CUP. LEFT SIDE AFFECTED. DOI: (B)(6) 2013, DOR: (B)(6) 2020. REVISION OF INLAY AND HEAD.

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

  MAUDE report 11329261 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WERE EXCHANGE FOR INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9520720 ↗
• InjuryNov 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD SEVERAL RECENT DISLOCATIONS.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8080638 ↗
• InjuryOct 11, 2018Noise, Audible; Separation Problem; Noise, Audible; Separation Problem

  IT WAS REPORTED THAT THE LINER WAS IMPLANTED INTO THE CUP SYSTEM. OVER TIME THE LINER DISASSOCIATED FROM THE CUP AND NEEDED TO BE REVISED. THE LINER WAS EXCHANGED FOR A LIPPED VERSION AND THE HEAD EXCHANGES FOR A 32 +9 CERAMIC TS HEAD. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 7955955 ↗
• InjuryJul 9, 2018Separation Problem; Separation Problem

  I HAVE HAD A REPORT FROM A CUSTOMER REGARDING A PROBLEM WITH A MARATHON LINER. THE REVISION CASE IS ON SATURDAY, THE LINER DISLOCATED OUT OF THE SHELL AFTER THE PATIENT HAD A FALL.

  Patient problems: Fall

  MAUDE report 7669399 ↗