PINNACLE GRIPTION 1217-30-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295010012), received between Jun 26, 2018 and Jun 19, 2026 — classified as 26 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENTIRE CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED IN ITS POSITION. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY AND THERE WAS NO HARM DONE TO THE PATIENT. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25562106 ↗
• InjuryMar 30, 2026Osseointegration Problem; Migration

  IT WAS REPORTED THAT THERE WAS A LOOSENING OF CUP WITH NO OBSERVED BONE INGROWTH. X-RAYS SHOWED MOST SCREWS HAD BEEN PULLED FROM THE BONE AND THE CUP HAD SHIFTED VERTICALLY. ACTIVITY LEVEL - YES DOI- (B)(6) 2024, DOR-(B)(6) 2026, AFFECTED SIDE-LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24733725 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUP, POLY, SCREWS, AND HEAD WERE REVISED FOLLOWING A PATIENT FALL THAT LEAD TO ACETABULAR FRACTURE. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22524235 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21711020 ↗
• InjuryFeb 19, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ALLEGATION AGAINST THE STEM OR HEAD.

  Patient problems: Insufficient Information

  MAUDE report 21415176 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A FAILED PINNACLE DUAL MOBILITY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17788676 ↗
• InjuryJul 11, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO CUP FAILURE. SURGEON EXPLANTED CUP, LINER, SCREWS AND PROX BODY DUE TO LOOSENING OF CUP. THERE WAS REPORTED LOOSENING OF NON-CEMENTED INTERFACE. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14976336 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONVERSION FROM TOTAL HIP TO PROSTALAC FOR POSSIBLE INFECTION. DOE: (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 14851939 ↗
• InjuryMay 4, 2022Migration; Migration

  PATIENT WAS REVISED DUE TO THE LEFT TOTAL HIP WITH A CUP THAT HAS GONE VERTICAL. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED NEW PARTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2022. DOR: (B)(6), 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 14278182 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13720997 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021(CUP,SCREWS,STEM) DOI: (B)(6) 2021(HEAD,LINER). DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13693364 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A RECLAIM PINNACLE DM TOTAL HIP DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A LONG C-STEM WITH MARATHON CEMENTED CUP WERE IMPLANTED AS A SPACER UNTIL THE INFECTION CLEARS. I AM UNSURE OF THE DATE OF THE DATE OF SURGERY, BUT I CAN TRY FIND OUT. THESE IMPLANTS HAD NOT BEEN IN FOR LONG. MALE, RIGHT SIDE. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12813190 ↗
• InjuryJul 15, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND HIP BECAME UNSTABLE. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOI: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Joint Laxity

  MAUDE report 12173448 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INFECTION, OSTEOMYLELITIS AND PAIN. OPERATIVE NOTE REPORTED 20 ML SEROUS FLUID AND FIBROUS TISSUES. DOI: (B)(6) 2013; DOR: (B)(6) 2014; RIGHT HIP (2ND REVISION).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Pain; Unspecified Infection

  MAUDE report 10636442 ↗
• InjuryJul 8, 2020Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN IN THEIR RIGHT HIP. THE SURGEON DETERMINED THE PAIN COULD BE CAUSED BY THE PATIENT'S MOM IMPLANTS. THE METAL LINER AND HEAD WERE REMOVED. POLYETHYLENE LINER AND CERAMIC HEAD WERE IMPLANTED. DOI: 2009, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Edema; Extraskeletal ossification; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Necrosis; No Code Available; Pain; Physical Asymmetry

  MAUDE report 10246428 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PULMONARY EMBOLISM. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (RIGHT HIP).

  Patient problems: No Code Available; Pulmonary Embolism

  MAUDE report 10096472 ↗
• InjuryFeb 26, 2020Naturally Worn; Migration; Naturally Worn; Migration

  PPF AND STICKER SHEETS RECEIVED. THERE WERE NO ALLEGATIONS REPORTED HOWEVER THE PATIENT WAS REVISED AND THE REASON FOR REVISION WAS NOT PROVIDED. DOI: (B)(6) 2017. DOR: (B)(6) 2017, (LEFT HIP, FIFTH REVISION).

  Patient problems: Hematoma; No Code Available

  MAUDE report 9753157 ↗
• InjuryOct 23, 2019Loss of Osseointegration; Loss of Osseointegration

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES PATIENT SUFFERS FROM PAIN, DIFFICULTY WALKING, AND FEELING THAT HIS RIGHT HIP IS NOT IN THE CORRECT PLACE. UPDATE 7/8/2015-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PART/LOT IS BEING UPDATED. IT SHOULD BE NOTED THAT THE DOI OF (B)(6) 2009 IS A REVISION OPERATION FROM A PREVIOUS HIP REPLACEMENT. MANUFACTURER OF THE PRODUCTS INVOLVED ARE UNKNOWN AT THIS TIME. THE COMPLAINT WAS UPDATED ON: 7/8/2015. UPDATE AD 30 OCT 2018: PPF ALLEGES DISLOCATION AND LOOSENING OF CUP. ADDED DOR, AGE, LAW FIRM, LAWYER, HOSPITAL, SURGEON, PATIENT HARM, NEW IP'S AND PEC. DOI: (B)(6) 2009. DOR: (B)(6) 2010. (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9226854 ↗
• InjuryOct 16, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES LOOSENING OF CUP, FRACTURE (BONE) AND ELEVATED METAL IONS AFTER FIRST REVISION. UNKNOWN HIP IMPLANT HAS BEEN ADDED TO CAPTURED THE ALLEGATION OF A FRACTURE AS ITS UNKNOWN WHERE THE FRACTURE WAS. IF/WHEN MORE INFORMATION IS RECEIVED, THE PC WILL BE UPDATED AS NEEDED. DOI: (B)(6) 2011; DOR: (B)(6) 2015; LEFT HIP. SEE (B)(4) RIGHT HIP. SEE (B)(4) LEFT HIP 1ST REVISION.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9199313 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, STICKER SHEETS, IMPLANT RECORDS RECEIVED. PPF ALLEGES STROKE AND HEART ATTACK. DOI: (B)(6) 2013 - DOR: NONE REPORTED (RIGHT HIP). DOI: (B)(6) 2005(STEM, SLEEVE, AND APEX HOLE ELIMINATOR). THIS PC IS FOR THE ALLEGATIONS AFTER FIRST REVISION OF THE RIGHT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Cardiac Arrest; Infarction, Cerebral

  MAUDE report 8983344 ↗
• InjuryJun 3, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE CUP LINER AND SCREWS WERE REMOVED FOR LOOSENING SUBSEQUENT TO A FALL. DOI: (B)(6) 2019, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8664593 ↗
• InjuryMar 6, 2019Use of Device Problem; Loss of Osseointegration; Use of Device Problem; Loss of Osseointegration

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES ONGOING PHYSICAL AND MENTAL PAIN, PHYSICAL INJURIES, EXTREME WEAKNESS, DIFFICULTY WALKING AND HIGH LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD SYSTEM. DOI: (B)(6) 2011, DOR: (B)(6) 2012, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Injury; No Code Available; Pain; Weakness

  MAUDE report 8395610 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PULMONARY EMBOLISM AFTER FIRST REVISION.

  Patient problems: Pulmonary Embolism

  MAUDE report 8375284 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION AFTER FIRST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 8214047 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS RIGHT PERIPROSTHETIC HIP INFECTION, SYNOVITIS, ABSCESS AND COMPLEX WOUND ON RIGHT HIP. REVISION NOTES REPORTED THAT THERE WAS SOME GROSSLY PURULENT MATERIAL.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 8070375 ↗