PINNACLE 1217-12-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295009146), received between May 18, 2018 and Feb 15, 2021 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  MEDICAL RECORDS RECEIVED AND REVIEWED: 2011: PATIENT UNDERWENT A LEFT HIP REPLACEMENT. MANUFACTURER OF THE IMPLANTS IS UNKNOWN. (B)(6) 2015: PATIENT UNDERWENT A RIGHT HIP REPLACEMENT WITH DEPUY IMPLANTS DUE TO OSTEOARTHRITIS. (B)(6) 2015: RADIOLOGY FILMS INDICATED NORMAL POSITIONING OF THE RIGHT HIP WITH NO LOOSENING. (B)(6) 2016: RADIOLOGY FILMS FOR THE RIGHT HIP INDICATED THE STEM WAS SLIGHTLY COLLAPSED WITH A LYTIC AREA UNDER THE SHOULDER OF THE STEM. CUP LOOSENING COULD ALSO NOT BE RULED OUT. (B)(6) 2016: PATIENT UNDERWENT A REVISION AFTER EXPERIENCING GRINDING/SQUEAKING AND DISLOCATION WITH SUSPECTED INLAY DISASSOCIATION. PATIENT WAS NOTED TO BE PAIN AND SYMPTOM FREE. X-RAY SHOWED DECENTRALIZED FEMORAL HEAD. REVISION OPERATIVE NOTE INDICATED SYNOVITIS, TROCHANTERIC BURSITIS, AND METALLOSIS. DISLOCATION AND DISASSOCIATION WERE CONFIRMED. THERE WERE SIGNS OF IMPLANT IMPINGEMENT, BUT IT WAS NOTED TO BE SECONDARY TO THE GRINDING AFTER THE DISASSOCIATION. THE FEMORAL HEAD AND ACETABULAR LINER WERE REVISED. THERE WAS NO INDICATION OF CUP LOOSENING, STEM MIGRATION, OR OSTEOLYSIS AS INDICATED ON THE (B)(6) 2016 RADIOLOGY FILMS. (B)(6) 2016: RADIOLOGY FILMS INDICATED NORMAL POSITIONING

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Inflammation; Pain; Synovitis

  MAUDE report 11329265 ↗
• InjurySep 21, 2020Loss of Osseointegration; Malposition of Device; Migration; Loss of Osseointegration; Malposition of Device; Migration

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE REASON FOR REVISION WAS LOOSE CUP, THE CUP HAD SANK IN THE MEDIAL WALL, ACCORDING TO SURGEON MAYBE DUE TO A PRIMARY MALPOSITION.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10560008 ↗
• InjuryJul 9, 2020Malposition of Device; Malposition of Device

  OPERATION DATE (B)(6) 2020 BY DR (B)(6) AT (B)(6). REVISION OF ACTETABULAR COMPONENTS FROM A PATIENT WHO HAD A PRIMARY HIP ON THE (B)(6)2018 BY DR (B)(6) AT (B)(6). PRIMARY ORIGINAL STEM WAS NOT REMOVED IN THIS REVISION ON THE HEAD, CUP, LINER, SCREWS AND INSERT.

  Patient problems: No Code Available

  MAUDE report 10251610 ↗
• InjurySep 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRIMARY IMPLANTED ON (B)(6) 2015. REASON FOR REVISION: LINER DISASSOCIATION (SMALL UP 48/ LARGE PATIENT). REVISION PERFORMED YESTERDAY AND HEAD/ LINER AND SHELL REPLACED.

  Patient problems: No Code Available

  MAUDE report 9132853 ↗
• InjurySep 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISION; DR (B)(6), (B)(6) SURGICAL CENTRE (B)(6) 2018. PRIMARY IMPLANTATION DATE: (B)(6) 2015. PATIENT PRESENTED TO DR (B)(6), SHE HAD DEVELOPED SQUEAKING IN HER HIP LAST WEDNESDAY. SURGERY BOOKED AND XRAYS REVEALED ECCENTRIC POSITIONING OF LINER AND DISLODGEMENT, FOR LINER AND HEAD EXCHANGE WITH CONSTRAINED LINER AS A BACKUP. DURING SURGERY METALLOSIS OBSERVED AND FRAGMENTS OF POLY AND COATING OF CERAMIC HEAD NOTED. REPLACEMENT LINER AND HEAD PUT INTO PATIENT. DAMAGED FEMORAL HEAD IMPACTOR TIP AND LINER TRIAL IN THE PROCESS. DR (B)(6) HAS REQUESTED AN INVESTIGATION AS THIS HAS HAPPENED BEFORE AND IS CONCERNED IT IS A POLY FAULT. FEMALE PATIENT ID: (B)(6), INITIALS (B)(6), DOB: (B)(6), AGED (B)(6).

  Patient problems: Tissue Damage

  MAUDE report 7893586 ↗
• InjuryMay 18, 2018Osseointegration Problem; Osseointegration Problem

  REVISION - DR (B)(6), (B)(6) HOSPITAL, (B)(6), (B)(6) 2018. PRIMARY IMPLANT (B)(6) 2018. CUP UNSTABLE. SURGEON COMMENTED PATIENT HAD FRACTURE. (B)(6) - PATIENT UNDERWENT REVISION SURGERY - CUP, HEAD AND LINER REMOVED, REPLACED WITH 52MM MULTIHOLED CUP AND MULTIPLE SCREWS, 36MM LINER AND TS HEAD. FEMALE PATIENT INITIALS (B)(6). DOI: (B)(6) 2018- DOR: (B)(6) 2018 (UNKNOWN HIP).

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Not Applicable

  MAUDE report 7526818 ↗