PINNACLE 1217-11-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295009054), received between Jul 5, 2018 and Jun 6, 2023 — classified as 5 injuries, 1 malfunction.

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

• InjuryJun 6, 2023Use of Device Problem; Use of Device Problem

  SURGEON REMOVED ACETABULAR CUP, LINER AND HEAD. REASON FOR OPERATION WAS PAIN, METALLOSIS, PSEUDO TUMOUR AND MAL POSITIONING OF ACETABULAR CUP. PRIMARY SURGERY WAS PERFORMED BY DR. AT HOSPITAL. I AM TRYING TO SOURCE MORE INFORMATION ON THE IMPLANTS REMOVED AS I HAVE VERY LIMITED INFORMATION. I DIDNT KNOW THAT IT WAS A 50 CUP, METAL LINER AND 36 HEAD, BUT I DO NOT KNOW SPECIFIC PRODUCT NAMES OR REFERENCES. I AM CURRENTLY SEARCHING MORE INFORMATION TO COMPLETE THIS REPORT. PATIENT STATUS/ OUTCOME / CONSEQUENCES? YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? METALLOSIS AND PSEUDO TUMOUR. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? YES. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST? TRUE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 17069851 ↗
• InjuryMay 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DATE EVENT (=DATE THE ISSUE TOOK PLACE): (B)(6) 2023. ( REVISION ) IMPLANTATION: (B)(6) 2019. PROCEDURE: TOTAL HIP AFTER A FRACTURE. DESCRIPTION OF ISSUE: LUXATION OF LINER, SCALLOPS OF THE LINER HAVE BROKEN OFF. WHEN DID THE EVEN OCCUR (PRE-OP/INTRA-OP/POST-OP)? POST-OP . WAS THERE ANY PATIENT CONSEQUENCE? YES , REVISION SURGERY ON DATE: (B)(6) 2023. WHAT ACTION WAS TAKEN TO RESOLVE THE ISSUE? REVISION SURGERY, PLACED A NEW LINER. HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE (MINUTES)?

  Patient problems: Insufficient Information

  MAUDE report 16896564 ↗
• MalfunctionDec 21, 2021Difficult to Remove; Difficult to Remove

  PINNACLE CERAMIC LINER JAMMED IN PINNACLE CUP AT TIME OF INSERTION. WAS NOT FULLY SEATED. LINER COULDN¿T BE REMOVED, TO RESEAT CORRECTLY. CUP AND LINER HAD TO BE REMOVED AND REPLACED WITH SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13054934 ↗
• InjuryJan 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REPORTED TO SURGEON WITH DISLOCATED HIP AFTER A FALL. SURGEON OPERATED ON PATIENT FINDING POLY LINER HAS BEEN DAMAGED INSIDE ACETABULAR SHELL. THE CERAMIC HEAD WAS ALSO DAMAGED. THE ACETABULAR SHELL WAS REMOVED FOR WAY OF A NEW PROSTHESIS ALSO. ADDITIONAL INFORMATION RECEIVED 1/4/21 REPORTING A DISASSOCIATION OF LINER FROM CUP HAD OCCURRED.

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

  MAUDE report 11170082 ↗
• InjuryAug 5, 2020Degraded; Device Dislodged or Dislocated; Naturally Worn; Degraded; Device Dislodged or Dislocated; Naturally Worn

  TODAY I COVERED A REVISION HIP , PATIENT HAD A TOTAL HIP REPLACEMENT DONE (B)(6) 2017. PATIENT HAD A CORAIL STEM WITH PINNACLE 100SERIOUS CUP WITH A 28MM /50MM NEUTRAL LINER. PATIENT NEEDED THE CUP AND LINER REVISION, CONSULT (SURGEON) REQUEST WE REVIEW THE LINER AS THE LOCKING MECHANISM APPEARED TO HAVE FAILED IN THE PATIENT. PATIENT AT THE TIME HAS A BMI OF OVER 56 BUT HAS SINCE LOST LOADS OF WEIGHT.

  Patient problems: Foreign Body Reaction; No Code Available; Pain

  MAUDE report 10367629 ↗
• InjuryJul 5, 2018Malposition of Device; Malposition of Device

  PINNACLE REVISION. RIGHT HIP. REVISED DUE TO LOOSENING OF THE STEM AND MALPOSITION OF THE CUP. DOI: (B)(6) 2008; DOR: (B)(6) 2016; (RIGHT HIP).

  Patient problems: Not Applicable

  MAUDE report 7664405 ↗