PINNACLE GRIPTION 1217-31-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295010210), received between Aug 21, 2017 and Feb 3, 2026 — classified as 15 injuries, 2 malfunctions.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AFTER TOTAL HIP ARTHROPLASTY (THA (CORAIL/PINNACLE), WHICH LED TO REVISION SURGERY INVOLVING EXPLANTATION AND REPLACEMENT OF THE CUP.

  Patient problems: Pain

  MAUDE report 24251280 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2018; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16185208 ↗
• InjuryDec 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE INLAY LUXATION AND REVISION. IF OTHER, DESCRIBE: TOTAL HIO PROSTHESIS. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? YES. IF YES, PLEASE DESCRIBE. PINNACLE INLAY LUXATION. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. FACILITY NAME OF ORIGINAL IMPLANT? (B)(6). WAS DEVICE EXPLANTED? TRUE. HARDWARE/EXPLANT REMOVAL DUE TO: INSERT LUXATION. DID PATIENT REQUIRE REVISION SURGERY? TRUE. IF YES, DATE OF REVISION SURGERY. (B)(6) 2022. REASON FOR REVISION SURGERY. INSERT LUXATION. PATIENT STATUS/ OUTCOME / CONSEQUENCES. YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? METALLOSIS AND CUP REVISION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. IP-01593609: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILA

  Patient problems: Foreign Body Reaction

  MAUDE report 15959212 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACETABULAR IMPLANT REVISION FOR HIP PAIN. DOI: (B)(6) 2021, DOR: (B)(6) 2022, UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 14619579 ↗
• InjurySep 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS DISSOCIATION OF THE LINER. THERE WAS SURGICAL DELAY AND NEEDED ADDITIONAL SURGERY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNKNOWN SIDE.

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

  MAUDE report 12519637 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS WERE EXPLANTED AND PUTTING IN A SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT HIP.

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

  MAUDE report 12475253 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT PATIENT IS INFECTED AND TAKING OUT IMPLANTS AND REPLACING WITH CEMENT SPACER. DOI: (B)(6) 2020 (CUP AND STEM); DOI: (B)(6) 2020 (HEAD AND LINER); DOR: (B)(6) 2021; RIGHT HIP.

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

  MAUDE report 11281135 ↗
• MalfunctionDec 16, 2020Difficult to Insert; Difficult to Insert

  SURGEON PUT PINNACLE CUP (PINNACLE 100 GRIPTION SIZE 54MM) TO THE PATIENT AND TRIED TO PUT APEX HOLE ELIMINATOR TO PLACE, BUT IT CAME THROUGH THE HOLE. HE TOOK A NEW APEX HOLE ELIMINATOR AND SAME HAPPENED. HE TOOK THE CUP AWAY AND PUT A NEW CUP WITHOUT APEX HOLE ELIMINATOR. SURGERY DELAYED BY 10-15MIN. THE PATIENT DID NOT SUFFER ANY HARM AND HAS RECOVERED WELL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019661 ↗
• InjuryOct 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF RIGHT TOTAL HIP ACETABULAR CUP. PATIENT KEPT DISLOCATING DUE TO POLY LINER NOT FULLY SEATED INTO ACETABULAR CUP AFTER PRIMARY SURGERY DONE 2 YEARS AGO.

  Patient problems: No Code Available

  MAUDE report 10748390 ↗
• MalfunctionOct 15, 2020Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS NO REVISION. OPENED A SIZE 54 100 SERIES GRIPTION CUP REF: 1217-31-054 LOT J8877K AND FOUND SOMETHING THAT LOOKED LIKE SOME PAPER MATERIAL ATTACHED TO THE GRIPTION. THE DOCTOR WAS QUESTIONING THE INTEGRITY AND STERILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683720 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE FACT SHEET AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN. AFTER REVIEW OF MEDICAL RECORDS. THERE WAS NO INFORMATION AFTER 1ST REVISION. DOI: (B)(6) 2019 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 10130641 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD UNDERGONE A REVISION SURGERY TO ADDRESS INFECTION. DOI: (B)(6) 2019 - DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9385384 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE FISSURE ACETABULUM. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019. (RIGHT HIP).

  Patient problems: Bone Fracture(s)

  MAUDE report 9312110 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE PULLED OUT. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9210127 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION SO THE DOCTOR PUT A CEMENT SPACER IN. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9151412 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN SIDE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7613667 ↗
• InjuryAug 21, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS SEVERE PAIN AND CUP LOOSENING.

  Patient problems: Pain

  MAUDE report 6807608 ↗