PINNACLE GRIPTION 1217-32-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295010357), received between Sep 21, 2017 and Sep 28, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (7 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 16, 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.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50919638 ↗
• InjuryAug 7, 2026Use of Device Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to malpositioned cup and pain. At revision non-articular surface of the polyethylene acetabular liner shows 1 screw hole defect.

  Patient problems: Pain

  MAUDE report 50180389 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED HIP. IMPLANTS WERE REMOVED AND TEMPORARY SPACER IMPLANTED. THERE WERE NO DELAYS, COMPLAINTS, AND NO HARM TO THE PATIENT. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25234074 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISION DUE TO INSTABILITY/DISLOCATION. NO OTHER INFORMATION IS KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 23837860 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS INFECTED SO IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PUT IN. ORIGINAL IMPLANT DATE: (B)(6) 2025. EXPLANT DATE: (B)(6) 2025.

  Patient problems: Unspecified Infection

  MAUDE report 23647050 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ACETABULAR COMPONENT WAS REVISED DUE TO ILIOPSOAS PAIN. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Pain

  MAUDE report 22793225 ↗
• InjuryJun 3, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE LOOSE INTERFACE WAS THE CUP AND THE ACETABULUM.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 19455365 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS REMOVED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18031323 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD CORAIL AND PINNACLE IMPLANTED IN (B)(6) 2022 AT ANOTHER FACILITY, SUBSEQUENTLY HAD SPINAL FUSION AND HAS DISLOCATED TWICE AND ALSO SHOWN SIGNS OF INFECTION AROUND THE JOINT AND DISTAL FEMORAL IMPLANT. THIS REQUIRED REVISION SURGERY TO REMOVE THE IMPLANT AND REPLACE WITH CORAIL REVISION STEM AND CEMENTED BIMENTUM CUP. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES; PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?: INFECTION; WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES; IF YES, DESCRIBE: XRAYS, REVISION SURGERY. IS THE PATIENT PART OF A CLINICAL STUDY: NO, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (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: Unspecified Infection

  MAUDE report 16806452 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF RECEIVED. PPF ALLEGES DISLOCATION, METAL WEAR, METALLOSIS, AND FRACTURE COMPONENT, THE UNKNOWN LINER, UNKNOWN HEAD, AND UNKNOWN COMPONENT WERE REPORTED TO THE IMPACTED PRODUCT DUE TO THE PPF ALLEGATIONS. DOI: (B)(6) 2012 - DOR: NONE REPORTED (RIGHT HIP). PLEASE SEE (B)(4) AND (B)(4) FOR THE LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Embolism/Embolus; Hypersensitivity/Allergic reaction; Inflammation; Joint Laxity; Pain; Pulmonary Embolism; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14653280 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAIN AND INSTABILITY. DOI: UNK DOR: (B)(6) 2021 LEFT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12200631 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT HAD A DRAINING OF SURGICAL WOUND PROCEDURE WITH EXTENSIVE SOFT TISSUE NECROSIS SECONDARY TO METALLOSIS FROM PREVIOUS EXPLANTED METAL ON METAL THA. OPERATIVE NOTE REPORTED THAT, UPON ENTERING THE WOUND THERE WAS NOTED TO BE EXTENSIVE SOFT TISSUE NECROSIS WITH A INCOMPLETE FASCIA LAYER. SOME OF THE NECROSIS EXTENDED INTO THE SUBCUTANEOUS TISSUES. THE PROXIMAL VASTUS LATERALIS WAS IDENTIFIED, THIS TOO APPEARED NECROTIC. DOI: (B)(6) 2007 (CUP, SCREW, STEM), DOI: (B)(6) 2021 (HEAD, LINER), DOE: (B)(6) 2021, RIGHT HIP.

  Patient problems: Fluid Discharge; Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 12089133 ↗
• InjuryApr 23, 2021Adverse 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 PAIN. DOI: (B)(6) 2020 DOR: (B)(6) 2021 AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 11713617 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLAIM LETTER RECEIVED ALLEGING PAIN, INABILITY TO WALK WITHOUT CRUTCHES, INABILITY TO MOVE, TROUBLE SLEEPING, SPASMS, DISCOMFORT, SUFFERING, SIGNIFICANT LOSS OF AMENITY. DOI: (B)(6) 2017 - DOR: (B)(6) 2018 (RIGHT HIP). EMAIL NOTIFICATION FROM (B)(6) RECEIVED ALLEGING INFECTION. PRIMARY SURGERY DATE HAS BEEN UPDATED TO (B)(6) 2015 AND REVISION DATE TO (B)(6) 2016. THE REVISION ON (B)(6) 2017 NOTED ON THE (B)(6) APPENDIX B MATCHES WITH THE SECOND STAGE REVISION MENTIONED ON THE ORIGINAL CLAIM LETTER. IT WAS INDICATED THAT DURING THIS DATE, THE INFECTION HAD SETTLED AND THE CLIENT'S HIP WAS NOW PUT BACK IN PLACE. IT IS UNKNOWN IF THE DEFINITIVE IMPLANTS ARE FROM DEPUY. IT SHOULD BE NOTED THAT AROUND TEN DAYS AFTER THE DEFINITIVES WERE IMPLANTED, THE PATIENT HAD EXPERIENCED PAIN AGAIN. IT WAS ALSO INDICATED THAT THIS CLAIM IS NOT ACTIVELY LITIGATED. DOI: (B)(6) 2015 - DOR:(B)(6) 2016 (RIGHT HIP).

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Muscle Spasm(s); No Code Available; Pain; Unspecified Infection

  MAUDE report 9769545 ↗
• InjuryJan 17, 2020Loss of Osseointegration; Loss of Osseointegration

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT COMPLAINTS OF PAIN AND ROM. THE PATIENT WAS THEN REVISED FOR LOOSE ACETABULAR COMPONENT AND FAILED METAL ON METAL LEFT THA. OPERATIVE NOTES REPORTED THAT THE ACETABULAR COMPONENT WAS GROSSLY LOOSED. THERE WAS A SIGNIFICANT AMOUNT OF METALLIC PSEUDCAPSULE. THERE WAS SOME SUPERIOR WEAR FROM THE FEMORAL HEAD. IT WAS INDICATED THAT THE SCREW WAS BROKEN AND REMOVED WITH PLIERS. DOI: (B)(6) 2010; DOR: (B)(6) 2015; LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9601829 ↗
• InjuryDec 20, 2019Use of Device Problem; Loss of Osseointegration; Osseointegration Problem; Use of Device Problem; Loss of Osseointegration; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT EXAMINATION OF THE PROVIDED X-RAY IMAGE FINDS NO EVIDENCE OF DEVICE FRACTURE, DISASSOCIATION OR ANYTHING INDICATIVE OF A PRODUCT PROBLEM. IT IS NOTED THE ACETABULAR CUP POSITION IS BOTH MORE VERTICAL THAN WOULD BE RECOMMENDED AND ALSO HAS LESS VERSION THAN WOULD BE RECOMMENDED.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9503963 ↗
• InjuryDec 17, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF, IMPLANT RECORDS AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSE CUP. STICKERS SHEETS INDICATED THAT PATIENT WAS REVISED FOR I&D. STICKER SHEETS ALSO PROVIDED MULTIPLE LINER STICKERS. DOI: (B)(6) 2010 (CUP,SCREW); DOI: (B)(6) 2011 (HEAD,LINER); DOR: (B)(6) 2012 (HEAD, LINER); RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9484232 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AND ELEVATED METAL IONS. DOI: (B)(6) 2012. DOR: (B)(6) 2012, (LEFT HIP). PPF NOTED THAT NOTHING WAS REMOVED ON THIS DATE BUT A CERAMIC IMPLANT WAS PUT IN TO FILL THE SPACE CREATED BY THE REMOVAL OF THE METAL IMPLANT REMOVED ON (B)(6) 2012. THIS PC IS FOR THE SECOND REVISION OF THE LEFT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9337454 ↗
• InjuryOct 15, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION AND LOOSENING OF CUP AFTER FIRST REVISION. DOI: (B)(6) 2010; DOR: (B)(6) 2011; (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9193906 ↗
• InjuryAug 20, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2014; DOR: (B)(6) 2019, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8910494 ↗
• InjuryApr 23, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF CUP, DISLOCATION AND INFECTION AFTER FIRST REVISION (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 8539902 ↗
• InjuryJan 23, 2019Loss of Osseointegration; Positioning Problem; Loss of Osseointegration; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD INSTABILITY AND CUP WAS MOVED INTO A VERTICAL POSITION. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE CUP AT BONE TO IMPLANT INTERFACE. REMOVED THREE (3) SCREWS. NO IDENTIFYING NUMBERS WERE OBSERVED.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8271709 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "LITITGATION" ALLEGES INFECTION AND FRACTURE (BONE) AFTER 1ST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 8159801 ↗
• InjuryNov 13, 2018Separation Problem; Separation Problem

  THE PATIENT WAS REVISED TO ADDRESS HIP DISLOCATION AND LINER DISASSOCIATION.

  Patient problems: No Code Available

  MAUDE report 8063653 ↗
• InjuryFeb 23, 2018Migration or Expulsion of Device; Osseointegration Problem; Migration or Expulsion of Device; Osseointegration Problem

  SUBJECT: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR MIGRATION / LOOSENING OF THE ACETABULAR SHELL. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. REVISION OF SHELL, LINER AND HEAD HAS OCCURRED. DOI: (B)(6) 2012; DOE: (B)(6) 2016; DOR: (B)(6) 2016; (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 7291789 ↗