PINNACLE 1219-28-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295013310), received between Apr 25, 2018 and Jan 28, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• InjuryJan 28, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ORIGINAL SURGERY WAS DONE IN 2003; LINER HAD BEEN DISSOCIATED - PINNACLE MARATHON.

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

  MAUDE report 11244255 ↗
• InjuryNov 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT THA REPLACEMENT IN (B)(6) 2002. PATIENT HAS DISSOCIATED THEIR PINNACLE LINER. PATIENT BROUGHT TO OR TO HAVE A LINER, AND HEAD EXCHANGE. DOI: 2002. DOR: (B)(6) 2020. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 10801347 ↗
• InjuryJul 7, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE DESCRIPTION FROM THE DISTRIBUTOR STATES: ON (B)(6) 2019 WE HELPED THE SURGEON IN A CEMENTLESS THP. THE SURGERY WENT VERY WELL. ON SATURDAY (B)(6) 2020, THE SURGEON CONTACTED ME TO RESUME SURGERY FOR THIS PATIENT. WEDNESDAY (B)(6) 2020, (14 MONTHS LATER), WE DID THE REQUIRED SURGERY. FINDING. THE INSERT CAME OUT OF ITS PLACE AND THEREFORE BECAME MOBILE. IT IS MISSING 3 NOTCHES OUT OF 6. WE LOOKED FOR THEM, WE DIDN'T FIND THEM.

  Patient problems: No Code Available

  MAUDE report 10240452 ↗
• InjuryMar 6, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD SOME POLY WEAR AND OSTEOLYSIS. SURGEON DID A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2001. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8395846 ↗
• InjuryFeb 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS HIP PAIN AND DISLOCATION. DOI: 2004; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 8358054 ↗
• InjurySep 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON REMOVED ALL IMPLANTS AND PLACED A PROSTALAC PROSTHESIS. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7850781 ↗
• InjuryApr 25, 2018Disassembly; Disassembly

  THE PATIENT WAS REVISED TO ADDRESS LINER DISASSOCIATION. IT WAS ALSO INDICATED THAT THERE WAS NO REPORT OF HARM. 54 OD 28 ID POLY LINER AND 28 +0 S-ROM METAL HEAD WERE REMOVED. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7458940 ↗