PINNACLE 1219-32-454Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295014348), received between Sep 17, 2020 and Oct 15, 2024 — classified as 4 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD 2 SUBSEQUENT DISLOCATIONS. HEAD & LINER EXCHANGE PERFORMED. NO CASE DELAY OR ADVERSE CONSEQUENCES TO THE PATIENT NO PRODUCT NUMBERS WERE VISIBLE ON THE PRODUCT. LOT NUMBERS ARE AS READ FROM THE FIELD NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2009. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20452122 ↗
• InjuryAug 23, 2024Naturally Worn; Naturally Worn

  PATIENT HAD REVISED DUE TO SUPERIOR WEAR OF PINNACLE LINER. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 20055528 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CONTACTED DPS CUSTOMER SERVICE. HE RECEIVED HIP-TEP RIGHT SIDE ON (B)(6) 2016. REVISION OF HIP HEAD AND INLAY AT UNKNOWN DATE IN UNKNOWN HOSPITAL. UPDATED EVENT DESCRIPTION: THE PATIENT WAS REVISED DUE TO LUXATION. DOI: (B)(6) 2016. DOR: UNKNOWN. RIGHT HIP.

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 19713246 ↗
• InjurySep 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED IN 2007 BY DR. (B)(6). THE PATIENT DID WELL UNTIL RECENTLY WHEN SHE HAD DISLOCATED HER HIP MULTIPLE TIMES AND HAD TO HAVE IT REDUCED IN THE ER. THE EXACT DATE OF THE PRIMARY SURGERY IS UNKNOWN, THE EXACT DATES OF DISLOCATIONS ARE UNKNOWN. THE SURGEON EXPLANTED A 54 + 4 NEUTRAL MARATHON LINER AND A 32MM + 3 METAL SROM HIP BALL TO TREAT RECURRENT DISLOCATIONS AND JOINT INSTABILITY. A NEW 36MM + 4 10 DEGREE 54MM LINER AND A 36MM + 9 CERAMIC SROM HIP BALL WERE IMPLANTED. DOI: 2007. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10547403 ↗