PINNACLE GRIPTION 1217-31-050Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE 100 ACETABULAR SHELL GRIPTION 100 50mm OD · Class 2 · Implant
All models of PINNACLE GRIPTION (57)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle Gription hip implant is a cemented metal-and-polymer hip replacement cup used in total hip surgery. The 30 reports mostly describe the cup or its liner coming loose or shifting out of position, sometimes fracturing, along with metal wear and repeat infections, with several patients needing revision surgery. There are 27 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295010197), received between Oct 16, 2017 and Feb 26, 2026 — classified as 27 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem10
- Device Dislodged or Dislocated10
- Fracture2
- Loose or Intermittent Connection2
- Noise, Audible2
- Device-Device Incompatibility1
- Difficult to Insert1
- Loss of Osseointegration1
Patient problems
- Pain6
- Unspecified Infection5
- Inadequate Osseointegration4
- Insufficient Information4
- No Code Available4
- Joint Laxity3
- Bone Fracture(s)2
- Fall2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2026Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED REVISION OCCURRED DUE TO MASSIVE METAL WEAR DURING INLAY DISLOCATION AND FRACTURE FOLLOWING EXTERNAL ENDOPROSTHETIC TREATMENT. NECESSARY REVISION INCLUDING CUP AND HEAD REPLACEMENT, AS WELL AS REMOVAL OF METAL WEAR AND PSEUDOTUMOR. DOI: (B)(6) 2024. DOR: (B)(6) 2026.
Patient problems: Bone Fracture(s); Hypersensitivity/Allergic reaction
MAUDE report 24460635 ↗InjuryDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE LINER THE CAME LOOSE FROM CUP AND REVISION WAS DONE TO FIX IT. THE LINER AND HEAD WERE REPLACED. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Insufficient Information
MAUDE report 23783243 ↗InjuryDec 5, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT FELL AND DISLODGED HER CUP. AFFECTED SIDE: UNKNOWN.
Patient problems: Fall; Inadequate Osseointegration
MAUDE report 23726319 ↗InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A HIP SURGERY (LEFT, FULL HIP) ON THE (B)(6) 2024. APPROXIMATELY 10 DAYS AFTER THE SURGERY PATIENT GOT FIRST INFECTION. SYMPTOMS WERE SWELLING, HIGH TEMPERATURE, SHIVERS, OOZING OF THE AREA. THE 2ND INFECTION CAME APPROX. 3 MONTHS AFTER SURGERY THE 3RD INFECTION OCCURRED ON (B)(6) 2025 WHERE PATIENT WAS ADMITTED TO HOSPITAL. THE 4TH INFECTION OCCURRED (B)(6) 2025 AND WAS TOLD PATIENT HAD SEPSIS/CELLULITIS. 5TH INFECTION APRIL (B)(6). IN ADDITION PATIENT HEARS A CLICKING NOISE AND A PINCHING FEELING COMING FROM THE DEVICE. PATIENT IS OFF WORK SINCE THIS SURGERY.
Patient problems: Cellulitis; Fever; Sepsis; Swelling/ Edema; Unspecified Infection
MAUDE report 22044521 ↗InjuryApr 21, 2025Use of Device Problem; Migration; Use of Device Problem; Migration
IT WAS REPORTED THAT PATIENT'S CUP WAS SHIFTED AND BECAME VERTICAL. DOCTOR IS GOING TO REPLACE CUP, LINER AND HEAD. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 21875501 ↗InjuryMar 12, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
HCP IS REPORTING TO NCA/BFARM: "PATIENT WITH CONDITION AFTER CEMENT-FREE HIP PROSTHESIS IMPLANTATION IN OUR CLINIC ON (B)(6) 2023. REGULAR POSTOPERATIVE COURSE. REPRESENTATION ON (B)(6) 2025 WITH NEW JOINT NOISES. CT AND X-RAY DIAGNOSTICS SHOWED A SUSPECTED INLAY DISLOCATION. REVISION SURGERY ON (B)(6) 2025 REVEALED THAT THE INLAY WAS FRACTURED AND DISLOCATED."
Patient problems: Bone Fracture(s)
MAUDE report 21586289 ↗InjuryJul 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT HIP.
Patient problems: Foreign Body Reaction
MAUDE report 19701477 ↗InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO SURGICAL DELAYS.
Patient problems: Joint Laxity
MAUDE report 19281254 ↗InjuryFeb 15, 2024Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible
IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP REPLACEMENT. PATIENT WAS DOING DEEP SIDE LUNGES RECENTLY AND AFTERWARDS, FELT SOMETHING NOT RIGHT IN THEIR HIP JOINT. X-RAYS REVEALED A PRESUMPTIVE LINER DISSOCIATION. SURGERY WAS PERFORMED AND IT WAS CONFIRMED THAT THE POLYETHYLENE ACETABULAR LINER HAD DISSOCIATED FROM THE PINNACLE 100 SERIES GRIPTION ACETABULAR SHELL. SURGEON REMOVED THE CERAMIC FEMORAL HEAD AND THE OLD ACETABULAR LINER FROM THE PATIENT. EXAMINED THE INSIDE OF THE SHELL AND DETERMINED THERE WAS NO DAMAGE. SURGEON THEN IMPLANTED A NEW FEMORAL HEAD AND A NEW NEUTRAL MARATHON POLYETHYLENE ACETABULAR LINER IN THE PATIENT. SURGERY FINISHED ACCORDING TO PLAN. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 18712242 ↗InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REVISED DUE TO HIP LUXATION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, LEFT HIP. 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? -- UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES -- , 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-01870815 DEVICE PROPERTY OF --NONE, DEVICE IN POSSESSION OF --NONE, IP-01870816 DEVICE PROPERTY OF --NONE, DEVICE IN POSSESSION OF --NONE, IP-01870817 DEVICE PROPERTY OF --NONE, DEVICE IN POSSESSION OF --NONE, IP-01870818 DEVICE PROPERTY OF --NONE, DEVICE IN POSSESSION OF --NONE, IP-01870819 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: Joint Laxity
MAUDE report 18041515 ↗MalfunctionSep 26, 2023Fracture; Fracture
AFTER EXAMINING THE GRIPTION ACETABULAR CUP, THERE WAS GRIPTION MISSING NEAR THE RIM OF THE CUP. DEFECTIVE CUP WAS DISCARDED AND A NEW ONE WAS OPENED. SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17818779 ↗InjuryFeb 28, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible
LITIGATION RECORDS RECEIVED. AFTER REVIEW OF RECORDS, IT WAS ALLEGED THAT SEVERAL WEEKS POST-OP, THE PATIENT EXPERIENCED LOUD POP AND SUBSEQUENT PAIN IN THE AREA WHERE THE SURGERY HAD TAKEN PLACE. SUBSEQUENTLY, THAT PATIENT UNDERWENT SEVERAL PAINFUL AND UNNECESSARY SURGERIES TO CORRECT THE PROBLEM AND IN TURN, RESULTED IN HER CONTRACTING LIFE-THREATENING INFECTION. DOI: (B)(6) 2020. DOR: NONE REPORTED. RIGHT HIP.
Patient problems: Adhesion(s); Distress; Joint Laxity; Loss of Range of Motion; Pain
MAUDE report 16455492 ↗InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2021 PATIENT REPORTED A LOT OF BLOOD COMING FROM INCISION, THIS IS MOST LIKELY A HEMATOMA, PATIENT ADVISED TO APPLY PRESSURE DRESSING ON (B)(6) 2021, THE PATIENT HAD A I&D WITH POLY LINER AND FEMORAL HEAD EXCHANGE TO ADDRESS INFECTED/SEPTIC TOTAL HIP. PATIENT IS CULTURE POSITIVE FOR MRSA. THE PATIENT PRESENTED WITH SWELLING, PAIN AND A FEVER. DEPUY POLY LINER WAS IMPLANTED ALONG WITH DEPUY CERAMIC FEMORAL HEAD. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED DUE TO VANCOMYCIN ACCUMULATION AND ACUTE KIDNEY INJURY DUE TO IV ANTIBIOTIC USE CAUSING ADVERSE EFFECTS. THE PATIENT WAS ALSO EXPERIENCING HALLUCINATIONS AND PERIPHERAL EDEMA. PATIENT STOPPED TAKING VANCOMYCIN AND WAS STARTED ON A DIFFERENT ANTIBIOTIC. DOI: (CUP AND STEM): (B)(6) 2020; DOI (HEAD AND LINER): (B)(6) 2021; RIGHT HIP.
Patient problems: Fever; Fluid Discharge; Hematoma; Pain; Renal Impairment; Swelling/ Edema; Unspecified Infection; Unspecified Kidney or Urinary Problem
MAUDE report 16451963 ↗InjuryFeb 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
LINER WHICH HAS DISLOCATED AND BEEN REVISED IN JULY LAST YEAR (2022) NOW THE LINER HAD DISLOCATED AGAIN AND THEY THINK IT IS SOMETHING WRONG WITH THE CUP. THE FIRST TIME WHEN THEY REVISED THE LINER IT WAS ALSO A SMALL AMOUNT OF METALOSIS, BUT THEY DID NOT FIND ANY HARM ON THE CUP AT THAT TIME. THEY ARE NOW PLANNING ON CHANGING THE CUP THE (B)(6) 2023. THE PATIENT GOT THE FIRST IMPLANT IN (B)(6) 2022, WHICH GOT REVISED IN (B)(6) 2022.
Patient problems: Foreign Body Reaction
MAUDE report 16427860 ↗InjuryFeb 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
LINER WHICH HAS DISLOCATED AND BEEN REVISED IN (B)(6) LAST YEAR (2022) NOW THE LINER HAD DISLOCATED AGAIN AND THEY THINK IT IS SOMETHING WRONG WITH THE CUP. THE FIRST TIME WHEN THEY REVISED THE LINER IT WAS ALSO A SMALL AMOUNT OF METALLOSIS, BUT THEY DID NOT FIND ANY HARM ON THE CUP AT THAT TIME. THEY ARE NOW PLANNING ON CHANGING THE CUP THE (B)(6) 2023. THE PATIENT GOT THE FIRST IMPLANT IN (B)(6) 2022, WHICH GOT REVISED IN (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 16418060 ↗InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 16271234 ↗InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.
Patient problems: Pain
MAUDE report 15537293 ↗InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO HIP INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 15237605 ↗MalfunctionMay 20, 2022Difficult to Insert; Difficult to Insert
APEX HOLE SCREW DID NOT FIT INTO THE PINNACLE CUP. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14452280 ↗InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION FOR RIGHT TOTAL HIP EXPLANT. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SIDE.
Patient problems: Unspecified Infection
MAUDE report 13802136 ↗InjuryFeb 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THR OF RIGHT HIP ON PATIENT DUE TO POLY LINER DISENGAGED FROM THE SHELL AND BROKE IN FEW PIECES. NO SURGICAL DELAY. SURGEON EXTRACTED CUP AND IMPLANTED MULTHOLE SHELL WITH SCREWS AND POLY INSERT. STEM WAS WELL FIXED, TAPER NOT DAMAGED AND REVISION HEAD USED. DOI: (B)(6) 2018. DOR: (B)(6) 2021. AWAITING RETURN OF PRODUCT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11306946 ↗MalfunctionFeb 9, 2021Device-Device Incompatibility; Device-Device Incompatibility
A COMPLAINT FROM A CUSTOMERS WAS RECEIVED WHERE THE INSERTER WAS JAMMED TO THE PINNACLE CUP AFTER INSERTION OF THE CUP. OUTCOME WAS THAT THE CUP HAD TO BE REMOVED AND REPLACED WITH A NEW ONE. THE INSERTER JAMMED IN THE CUP. THE CUP HAD TO BE REMOVED. THE CUP IS STILL CONNECTED TO THE INSERTER. OCCURRED DURING SURGERY. SURGICAL DELAY OF 15 MINUTES.
Patient problems: Insufficient Information
MAUDE report 11300450 ↗InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEFT HIP REV - ORIGINAL SURGERY DONE (B)(6) 2018. REMOVED ALL IMPLANTS DUE TO INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9323646 ↗InjuryFeb 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF LINER AND CUP. NO KNOWN TRAUMA INDICATED. LEFT HIP.
Patient problems: No Code Available
MAUDE report 8316672 ↗InjuryJan 28, 2019Loss of Osseointegration; Loss of Osseointegration
PPF ALLEGES LOOSENING OF CUP, LOOSENING OF STEM, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS.
Patient problems: Inadequate Osseointegration; Tissue Damage
MAUDE report 8281461 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page