PINNACLE 1219-32-156Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295014072), received between May 7, 2019 and Jun 20, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL HIP DONE 28YEARS AGO BY AN UNKNOWN SURGEON AT UNKNOWN HOSPITAL. X-RAYS SHOWED IT TO BE A CORAIL STEM AND PINNACLE CUP. PATIENT WAS SHOWING SIGNS OF POLY WEAR AND BROUGHT IN FOR HEAD AND LINER EXCHANGE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19575097 ↗
• InjurySep 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO THE LEFT HIP INSTABILITY. NO REPORTED LOOSENING. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15397947 ↗
• InjuryAug 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON REPORTED TO BFARM: "INLAY DISLOCATION OF THE RIGHT HIP AFTER PRIMARY CEMENTLESS DEPUY HIP TEP RIGHT 01/2017. NOW REVISION OF RIGHT HIP WITH CUP CHANGE (MÜLLER SUPPORTER CUP, SIZE 54, 4-TIMES SCREW-RETAINED, CEMENTED TRILOC-2- PE CUP SIZE 52/32, MERETE BIOBALL 2XL SLEEVE 10.5MM, CERAMIC HEAD Ø 32MM) AND ALLOGENEIC BONE GRAFT ACETABULUM". DOI: (B)(6) 2017. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15223723 ↗
• InjuryMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP POLYETHYLENE DISLOCATION, PATIENT WAS REVISED FOR THE SAME INCIDENT ON SEPTEMBER. DOI: UNKNOWN; DOR: (B)(6) 2022; RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 14353924 ↗
• InjuryOct 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY AND THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT SIDE.

  Patient problems: Pain

  MAUDE report 12569652 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE CUP BROKEN THROUGH THE MEDIAL WALL AND NEEDED REVISION DUE TO INSTABILITY AND PAIN. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE (NON-CEMENTED). NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11445150 ↗
• InjurySep 15, 2020Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO POST LEFT TOTAL HIP ARTHROPLASTY WITH ACUTE DISPLACEMENT OF POLYETHYLENE LINER PROBABLY SECONDARY TO AN EPISODE OF INSTABILITY. THERE WAS SOME ANTERIOR WEAR ON THE 10 DEGREES HIP WHICH COULD HAVE COME FROM PERHAPS A SUBLUXATION OR PERHAPS NECK IMPINGEMENT. THERE WAS SOME MINIMAL WEAR ON THE HEAD. THE LINER AND HEAD WERE REMOVED. DOI: (B)(6) 2007- DOR: (B)(6) 2010 (LEFT HIP, FIRST REVISION).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10535820 ↗
• InjuryMay 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION. DOI: (B)(6) 2006; DOR: (B)(6) 2007; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8588273 ↗