PINNACLE GRIPTION 1217-32-064Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295010364), received between May 11, 2018 and Dec 26, 2024 — classified as 8 injuries.

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

• InjuryDec 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A HEAD BALL AND LINER EXCHANGE ON A PATIENT WHO HAD COME BACK IN DUE TO PAIN. THE LINER FOR CUP HAD POPPED OUT. THE STEM AND HEAD BALL WERE SITTING SUPERIOR IN CUP. THE HEAD BALL SHOWED WEAR AND LINER SHOWED WEAR AS WELL WITH POSSIBLE BROKEN TAB. THE INITIAL SURGERY WAS THREE YEARS PRIOR TO THE REVISED DATE OF (B)(6) 2024, THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Pain

  MAUDE report 21018987 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED, ON (B)(6) 2017 MRI WAS NOTED TO SHOW HETEROTOPIC BONE FORMATION SUPERIOR TO THE GREATER TROCHANTER AND ALSO AN EXOSTOSIS AT THE LEVEL OF THE GRATER TROCHANTER. THE SURGEON¿S IMPRESSION IS THE PATIENT HAS A LEFT TOTAL HIP ARTHROPLASTY WITH NO EVIDENCE FOR HARDWARE FAILURE OR OF OSTEOLYSIS. THERE IS A SMALL JOINT EFFUSION AND DEHISCENCE OF THE CAPSULE WITH FLUID OVER A PORTION OF THE GREATER TROCHANTER AND SEPARATION OF CORRESPONDING PORTIONS OF THE GLUTEUS MINIMUS AND GLUTEUS MEDIUS TENDONS. THE PATIENT CONTINUED TO HAVE PAIN AND ABDUCTOR WEAKNESS. THE PATIENT RECEIVED A STEROID INJECTION. DOI: (B)(6) 2011. DOE: (B)(6) 2017; LEFT HIP.

  Patient problems: Extraskeletal ossification; Fatigue; Pain; Swelling/ Edema; Wound Dehiscence

  MAUDE report 16833719 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION AND MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT CONTINUES TO EXPERIENCE PAIN, SUFFERINGS AND DIFFICULTY WALKING AND ELEVATED METAL IONS. MEDICAL RECORDS REPORTED THAT THE REASON FOR THE PERSISTENT PAIN IS WEAKNESS OF HIP ABDUCTORS WHICH WAS NOTED ON PHYSICAL EXAMINATION. PATIENT ALSO HAD HARDENED APPROACH AT THE HIP REPLACEMENT WHICH HAS LED TO DETACHMENT OF THE ANTERIOR 1/3 OF THE GLUTEUS MEDIUS AND MINIMUS AS NOTED ON THE MRI SCAN THAT HE HAD. DOI: (B)(6) 2011, DOR: NONE REPORTED, LEFT HIP. LINKED TO (B)(4) WHICH CAPTURES 1ST REVISION OF LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Discomfort; Extraskeletal ossification; Fatigue; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13344696 ↗
• InjuryMay 18, 2021Use of Device Problem; Noise, Audible; Migration; Use of Device Problem; Noise, Audible; Migration

  MEDICAL RECORDS REVIEWED: ON (B)(6) 2016 THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY AND A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. LEFT HIP: DEPUY PINNACLE CUP ALONG WITH SROM WERE USED DURING THIS PROCEDURE. RIGHT KNEE ARTHROPLASTY: COMPETITOR PRODUCTS, INCLUDING COMPETITOR CEMENT WERE USED DURING THIS PROCEDURE WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2016 PATIENT HAD A REVISION LEFT HIP TO ADDRESS LEFT HIP IMPLANT DISSOCIATION, AND CLICKING IN HIP. THERE WAS A DISASSOCIATION BETWEEN THE FEMORAL HEAD COMPONENT AND THE STEM. DURING THE PROCEDURE THE SURGEON NOTED THE ACETABULAR CUP HAD SHIFTED WITH THE ANTERIOR DISPLACEMENT OF THE STEM. THE STEM WAS NOTED TO BE WELL FIXED. THE SURGEON REPORTED THAT THE ACETABULUM APPEARED TO HAVE SHIFTED SLIGHTLY AND THE ASSUMPTION WAS MADE THAT THERE WAS INCREASED ANTEVERSION THAT MAY HAVE CONTRIBUTED TO THE DISSOCIATION. THE CUP WAS REVISED, ALONG WITH THE LINER, HEAD, AND STEM. TWO SCREWS WERE USED TO FIX CUP. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Physical Asymmetry; Swelling/ Edema

  MAUDE report 11844633 ↗
• InjuryNov 16, 2018Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES PAIN, DISCOMFORT, INFLAMMATION, POPPING AND SNAPPING AND ELEVATED METAL ION LEVELS. UPDATE AD 01 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, LOOSENING OF CUP, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. ADDED PATIENT'S AGE, STATE, DATE OF REVISION, SURGEON, LAW FIRM AND PRODUCT DETAILS. ADDED CUP AND SCREWS DUE TO ITS REVISION OF ALLEGED LOOSENING OF CUP. STEM IS A NON DEPUY.

  Patient problems: Inadequate Osseointegration; Tissue Damage

  MAUDE report 8077411 ↗
• InjuryAug 22, 2018Loose or Intermittent Connection; Loss of Osseointegration; Osseointegration Problem; Loose or Intermittent Connection; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES LOOSENING OF CUP AND METAL WEAR/METALLOSIS. DOI: (B)(6) 2009; DOR: (B)(6) 2011; (LEFT HIP).

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Inadequate Osseointegration; No Code Available; Not Applicable; Tissue Damage

  MAUDE report 7804423 ↗
• InjuryJul 10, 2018Malposition of Device; Malposition of Device

  CUSTOMER IS REPORTING A COMPETITOR (LINK) HIP HEAD DIA 40 MM TO LUXATE FROM DEPUY CONSTRAINED LINER WHEN THE RING WAS STILL CLOSED. SEE ATTACHED X-RAYS.

  Patient problems: No Code Available; Synovitis

  MAUDE report 7675250 ↗
• InjuryMay 11, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS ELEVATED METAL IONS. DOI: (B)(6) 2010; - DOR: (B)(6) 2011; (RIGHT HIP). 11/7/2012 - LITIGATION PAPERS RECEIVED. IN ADDITION TO ELEVATED METAL IONS, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, DECREASED MOBILITY, AND A CONSTANT LIMP. UPDATE: 1/31/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

  Patient problems: Discomfort; Hypoesthesia; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Nerve Damage; Not Applicable

  MAUDE report 7506751 ↗