PINNACLE GRIPTION 1217-31-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295010203), received between Jul 21, 2017 and Apr 28, 2026 — classified as 27 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT WHO HAD A THA IN 2020 (CORAIL/PINNACLE) FALL 2 WEEKS AGA AND SUBLUXATED HIS ACETABULAR CUP INLAY.

  Patient problems: Fall; Pain

  MAUDE report 25012783 ↗
• InjurySep 3, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT FELL AND FRACTURE ACETABULUM. ALL IMPLANTS WERE REMOVED AND REVISED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration

  MAUDE report 22954695 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN DOR- (B)(4) 2024 AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 19446932 ↗
• InjuryMay 7, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN. THE SURGEON SUSPECTED A LOOSE ACETABULAR COMPONENT AND OR POSSIBLE INFECTION. DR. WENT IN AND FOUND JUST THAT, HE REMOVED THE ACETABULAR SHELL, INSERT AND FEMORAL HEAD TO HELP WITH THE EXPOSURE. ONCE THE SHELL, INSERT AND HEAD WERE REMOVED, DR. PERFORMED AN EXTENSIVE I&D. AFTER THE I&D DR. THEN PREPARED THE ACETABULUM FOR A PINNACLE 58MM DPX SHELL AND NEW INSERT. DR. CHECKED THE FEMORAL STEM AND BECAUSE IT WAS WELL ALIGNED AND SOLIDLY FIXED, THE STEM WAS RETAINED. HE ONLY HAD TO REPLACE THE FEMORAL HEAD WITH A 36+8.5 TS CERAMIC HEAD. THE PATIENT WAS CLOSED IN HIS USUAL FASHION. DOI: UNKNOWN DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 19260443 ↗
• InjuryApr 23, 2024Osseointegration Problem; Osseointegration Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: ACETABULAR CUP LOOSENING AND PAIN. AT REVISION THERE WAS FRETTING ON THE FEMORAL HEAD AND MODERATE YELLOWING ON THE ACETABULAR LINER.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19167966 ↗
• InjuryFeb 19, 2024Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  "THE PATIENT DID A LUNGE STEP TEN DAYS AGO. SINCE THEN SHE HAS HAD PAIN, MOVEMENT RESTRICTIONS, AND NOISES IN HER LEFT HIP. CONDITION AFTER HIP JOINT IMPLANTATION IN (B)(6) 2018. REVISION FOR INLAY DISLOCATION IN (B)(6) 2022 (INLAY CHANGE SIZE 52 STANDARD)".

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 18730125 ↗
• InjurySep 22, 2023Off-Label Use; Device Dislodged or Dislocated; Naturally Worn; Off-Label Use; Device Dislodged or Dislocated; Naturally Worn

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2012, THE PATIENT HAD A LEFT HIP ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. NO MENTION OF MANUFACTURER OF CEMENT. ON (B)(6) 2021, THE PATIENT HAD A REVISION LEFT TOTAL HIP TO ADDRESS MECHANICAL COMPLICATION OF LEFT HIP PROSTHESIS. THE INDICATIONS FOR SURGERY INCLUDED, SYMPTOMS CONSISTENT WITH METALLOSIS AND EXCESSIVE WEAR. DURING THE PROCEDURE, THE SURGEON OBSERVED GROSS BLACK TISSUE STAINING AND A PSEUDOTUMOR. THE SURGEON NOTED THAT THE POLYETHYLENE SHELL COMPLETELY BROKEN FREE OF THE LINER AND THE HEAD WAS ARTICULATING WITH THE CUP. THERE WAS A LARGE AMOUNT OF TITANIUM WEAR DEBRIS IN THE SHELL. THE DEPUY ACETABULAR CUP WAS RETAINED AND THE SURGEON ELECTED TO USE A BUR TO ROUGHEN THE UNDERSURFACE OF THE CUP. THE SURGEON THEN ROUGHENED UP THE BACK OF THE NEW CUP AND CEMENTED THE COMPETITOR CUP INTO THE RETAINED DEPUY CUP. THE STEM, HEAD, AND ACETABULAR LINER WERE REMOVED. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2021 THE MEDICAL RECORDS NOTE THE PATIENT HAD MULTIPLE SURGERIES: 9 ON THE RIGHT HIP, 3 ON THE LEFT HIP (NO SPECIFIC INFO). PATIENT REPORTS HAVING CONST

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 17798423 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. PRIMARY PROCEDURE ON (B)(6) 2022. HEAD/LINER EXCHANGE ON (B)(6) 2023. DOI: (B)(6) 2022. DOR:(B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17563568 ↗
• InjuryJul 5, 2023Use of Device Problem; Use of Device Problem

  BAD POSITIONING OF THE CUP (TOO MUCH ANTEVERSION) AND PAIN DUE TO BAD POSITIONING PATIENT STATUS/ OUTCOME / CONSEQUENCES :YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?:PAIN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: :YES, IF YES, DESCRIBE :RÉVISION OF THE CUP , IP-01763337 IP-01763338 IP-01763339 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: Pain

  MAUDE report 17259730 ↗
• InjuryJun 9, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED AS FOLLOWS: THE PREVIOUS HIP IMPLANT FROM (B)(6) 2021 COLLAPSED ON (B)(6) 2023 WHEN THE PATIENT WAS STANDING ON A SLIGHTLY SLANTED PART OF A SIDEWALK; THE SLANTED PART OF THE SIDEWALK IS DECLINED IN A WAY TO ALLOW WHEELCHAIRS, BABY STROLLERS, ETC., TO HAVE BETTER ACCESS TO A SIDEWALK FROM A STREET. THE 2021 IMPLANT STRUGGLED TO MAINTAIN ITS STRENGTH WHILE THE PATIENT WAS STANDING ON PART OF THAT SLANTED SIDEWALK. PRIOR TO THE COLLAPSE OF THE IMPLANT, THE PATIENT WAS TAKING A LEISURELY WALK AND WAS IN A STANDING POSITION ON THE SLANTED PART OF THE SIDEWALK WHEN THE COLLAPSE OCCURRED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inflammation; Joint Laxity; Unspecified Musculoskeletal problem

  MAUDE report 17099111 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO SURGICAL DELAY WAS THERE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 17079024 ↗
• InjuryApr 11, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT PRESENTED IN OFFICE WITH PAIN IN HIP AREA FROM PREVIOUS SURGERY. UPON SURGERY SURGEON FOUND CUP TO BE LOOSE DUE TO PROBABLE INFECTION. CUP, LINER AND HEAD WERE REMOVED AND PATIENT WAS IRRIGATED AND DEBRIDED. SURGEON THEN OPTED TO PUT A MOD ENDO HEAD ONTO WELL FIXED STEM WHILST AWAITING RESULTS OF TISSUE SAMPLE TESTING. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 16712275 ↗
• InjuryJul 1, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN AFTER A FALL. UPON X-RAY, THE CUP APPEARED TO HAVE SLIPPED TO A NON SATISFACTORY ANTI VERSION TO THE DOCTOR. THE SURGERY WAS SCHEDULED TO REPLACE THE CUP WITH A BIGGER SIZE WITH SCREWS AND PUT IN THE DUAL MOBILITY SYSTEM. SURGERY WAS A SUCCESS. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Pain

  MAUDE report 14884716 ↗
• InjuryJun 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SURGEON COMPLETED A PRIMARY CORAIL/PINNACLE SURGERY IN (B)(6) 2017. IN (B)(6) 2020, THE ORIGINAL LINER DISSOCIATED FROM THE CUP AND THE FIRST REVISION SURGERY WAS PERFORMED BY ANOTHER SURGEON. THIS SURGERY CONSISTED OF A LINER CHANGE. IN (B)(6)OF 2022 THE LINER DISSOCIATED FROM THE CUP AGAIN. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 BY BOTH SURGEONS. THE ORIGINAL CUP WAS REMOVED AND A PINNACLE SECTOR CUP IMPLANTED WITH A NEW LINER. THE HEAD WAS ALSO REMOVED AND CHANGED. NO DELAY TO SURGERY. THE PATIENT HAS NOW HAD TO UNDERGO TWO REVISION SURGERIES. DOI:(B)(6) 2020. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Insufficient Information; Pain

  MAUDE report 14653249 ↗
• InjuryJan 10, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND EXPLANTED THE CUP. THERE WAS LOOSENING BONE TO IMPLANT INTERFACE. WENT BACK IN WITH DUAL MOBILITY. DOI: (B)(6) 2021;DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 13203513 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12563148 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO 2ND STAGE IMPLANTATION BECAUSE OF INFECTION. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019. DOR: (B)(6) 2021. (LEFT HIP).

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

  MAUDE report 12540314 ↗
• InjurySep 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SURGEON PERFORMED A REVISION TOTAL HIP ARTHROPLASTY ON A PATIENT WHO HAD BEEN PLAYING SOCCER AND COMPLAINED OF A STRANGE INSTABILITY THAT BEGAN TO OCCUR DURING SOCCER. THE SURGEON EXPOSED AND FOUND THAT THE LINER HAD DISSOCIATED FROM THE SHELL. THE SURGEON NOTED THAT THE LINER SHOWED SIGNS OF DEFORMATION AND THE ARD TABS HAD SHEARED OFF. THE CERAMIC FEMORAL HEAD HAD VISIBLE STRIPE WEAR. THE SHELL WAS WELL-FIXED AND IN GOOD CONDITION. THE STEM WAS WELL-FIXED AND IN GOOD CONDITION. IF THE LINER HAD NOT DISASSOCIATED, THE STRIPE WEAR WOULD NOT HAVE OCCURRED. THE SURGEON THEN REMOVED THE DAMAGED HEAD AND LINER, WASHED AND IRRIGATED THE WOUND THOROUGHLY, AND PROCEEDED TO IMPLANT A NEW FEMORAL HEAD AND NEW LINER WHICH MATCHED THE SIZE OF THE PREVIOUS LINER. THE SURGERY FINISHED SUCCESSFULLY ACCORDING TO PLAN. DOI: UNKNOWN DOR: (B)(6) 2021. UNKNOWN SIDE.

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

  MAUDE report 12495612 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN IN THIGH SO THE DOCTOR REVISES STEM AND CUP. DOI: (B)(6) 2015 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Pain

  MAUDE report 12163780 ↗
• InjuryJan 22, 2021Migration; Migration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2021 AND FOLLOWING THE POSTOPERATIVE CONTROL X-RAY THE CUP HAD TIPPED OVER. THE REVISION WAS THE FOLLOWING DAY, (B)(6) 2021. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? -NO. 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, WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: CUP HAD TIPPED OVER , DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. (B)(6) 2021, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? REVISION, 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, IP-01061148, DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01061149, DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, BY CHECKING THI

  Patient problems: Insufficient Information; Pain

  MAUDE report 11214903 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BURSITIS. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT HIP). TREATMENT: INJECTION : LIDOCAINE AND DEXAMETHASONE.

  Patient problems: Inflammation; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10442665 ↗
• InjuryJun 15, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT A NON-CEMENTED 100 CUP BECAME LOOSE, SECTOR CUP PUT IN WITH ONE SCREW. DOI: (B)(6) 2020. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10155062 ↗
• MalfunctionApr 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE KINCISE IMPACTOR BROKE WHILE INSERTING THE CUP. SURGEON AND STAFF WERE NOT ABLE TO GET THE CUP OF THE BROKEN INSERTER. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911842 ↗
• MalfunctionDec 26, 2019Break; Fracture; Break; Fracture

  PINNACLE 100 SERIES GRIPTION CUP WAS IMPLANTED AND THEN EXPLANTED TO ADJUST THE FIT. AT THAT POINT IT WAS NOTICED THAT A SIZABLE PIECE OF POROUS COATING AT THE RIM HAD COME OFF THE CUP. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5 MINUTES. ACTION TAKEN WHEN EVENT OCCURRED? CUP WAS REPLACED, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9520957 ↗
• MalfunctionNov 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT WOULD NOT LOOSEN FROM CUP IMPACTOR. HAD TO PULL CUP OUT ATTACHED TO IMPACTOR AND OPEN A NEW CUP. LEFT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9375650 ↗