PINNACLE GRIPTION 1217-32-054Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE GRIPTION ACETABULAR SHELL SECTOR 54mm 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 socket has 169 reports, with no deaths and 153 injuries. Reports mostly describe the socket loosening from the bone, infections, pain, and parts moving out of place, and many injury reports describe revision surgery to replace the parts. No recalls name this device, and reports fell from 17 in the prior 12 months to 7 in the latest 12 months.
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
- 169
- Deaths reported
- 0
- Injuries reported
- 153
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 10603295010319), received between Jul 27, 2017 and Jun 10, 2026 — classified as 153 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (23 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 Problem76
- Osseointegration Problem23
- Device Dislodged or Dislocated16
- Loss of Osseointegration16
- Difficult to Insert9
- Migration8
- Use of Device Problem7
- Insufficient Device Problem Information6
Patient problems
- No Code Available47
- Pain46
- Unspecified Infection42
- Inadequate Osseointegration37
- Joint Laxity14
- Insufficient Information11
- Discomfort9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
Recent adverse event reports
The 25 most recent of 169 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Osseointegration Problem
IT WAS REPORTED THAT REMOVAL OF ALL COMPONENTS IN AN INFECTED TOTAL JOINT WITH AN ACETABULAR FRACTURE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE- LEFT HIP.
Patient problems: Bone Fracture(s); Inadequate Osseointegration; Unspecified Infection
MAUDE report 25461416 ↗InjuryApr 13, 2026Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE LOOSENING OF THE CUP. LOOSENING WAS BETWEEN THE ACETABULAR SHELL AND THE BONE. LOOSE PINNACLE CUP WAS REMOVED. REPLACED WITH A COMPETITOR'S CUP. AFFECTED SIDE: LEFT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 24860398 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE ADVISE THE REASON FOR REVISION? - THE STEM HAD SUBSIDED WITHIN THE FEMUR. B. WHAT CAUSED THE INSTABILITY? - DUE TO SHORTENING. C. DID THE PATIENT HAVE ANY OTHER HARDWARE TO TREAT THE FEMUR FRACTURE? - NO OTHER HARDWARE PRESENT.
Patient problems: Fall; Joint Laxity
MAUDE report 24475254 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS INFECTED. THE DEVICES WERE EXPLANTED AND A SPACER WAS IMPLANTED. AFFECTED SIDE-RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24323726 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 24212107 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REVISED FOR INSTABILITY. NO IMPLANT ISSUES. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2014, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 24006160 ↗InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
IT WAS REPORTED THAT THERE WAS IMPINGEMENT ON THE LINER. SURGEON REPLACED THE CERAMIC HEAD, CUP AND LINER DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 23898888 ↗InjuryAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR REVISION SURGERY DUE TO LINER DISASSOCIATION. SURGEON WILL BE REMOVING AND REPLACING THE CUP AND LINER. THE OPERATING SURGEON FEELS THERE MUST BE AN ISSUE WITH THE LOCKING MECHANISM FOR THE CUP.
Patient problems: Insufficient Information
MAUDE report 22725231 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION AFTER PRIMARY THA. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 22688690 ↗InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS DRAINING FROM ORIGINAL IMPLANTATION THE WEEK BEFORE. SURGEON BELIEVES THERE IS SOMETHING GOING ON WITH THE PATIENT¿S HEALTH, NOT IMPLANT OR SURGICAL PROCEDURE ISSUE. ALL IMPLANTS WERE REMOVED AND WASHOUT WAS PERFORMED WITH NOW IMPLANTATION OF ALL IMPLANTS. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Fluid Discharge
MAUDE report 22419708 ↗InjuryJun 20, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE CUP LOST POSTERIOR FIXATION AND NEEDED REVISION COMPONENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 22302271 ↗InjuryMay 19, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY. A PINNACLE LINER HAS DISASSOCIATED FROM THE CUP. THE CUP WAS NOT REVISED, BUT SURGEON NOTED THERE WAS DAMAGE TO THE CUP WITH THE CERAMIC HEAD ARTICULATING AGAINST IT. INITIAL PROCEDURE WAS DONE A FEW WEEKS PRIOR.
Patient problems: Insufficient Information
MAUDE report 22047663 ↗InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE ALL PARTS WERE REMOVED DUE TO INFECTION OF THE HIP JOINT. THERE WAS STEM LOOSENING FROM INFECTION AT THE NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21924947 ↗InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 21654676 ↗InjuryMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE LINER FROM THE CUP AFTER 10 YEARS. THE SURGEON BELIEVES IT WAS DUE TO A SPINAL FUSION THAT RECENTLY OCCURRED. THE SURGEON REVISED THE CUP AND USED A DUAL MOBILITY CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21582336 ↗InjuryMar 3, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT HAD RESECTION ARTHROPLASTY PERFORMED AND SEPTIC LOOSENING. THERE WAS STEM AND CUP LOOSENING IN NON-CEMENTED INTERFACE. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2018, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Inadequate Osseointegration; Sepsis
MAUDE report 21510480 ↗InjuryJan 29, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT PATIENT NEEDED AN ACETABULAR REVISION. SURGEON THOUGHT THE CUP WAS LOOSE. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 21267465 ↗InjuryJan 28, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. UPON X-RAY, CUP FOUND TO HAVE BECOME LOOSE AND SHIFTED DUE TO A FRACTURE IN THE ACETABULAR AREA NOT RELATED TO SURGERY. STEM WAS WELL FIXED AND DID NOT REPLACE. SURGEON REAMED UP AND PLACED A MULTI HOLE CUP AND DUAL MOBILITY SYSTEM. PATIENT WAS LEFT SURGERY WILL FIXED AND STABLE. SURGEON WAS SATISFIED WITH SUCCESSFUL SURGERY. AFFECTED SIDE: RIGHT HIP.
Patient problems: Bone Fracture(s)
MAUDE report 21255055 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT DEVELOPED A URINARY TRACT INFECTION WHICH HAS MADE THEM VERY ILL. INFECTION IN THE JOINT HAS SINCE DEVELOPED, AS SURGEON NOTED PATIENT HAD BEEN DOING WELL BEFORE THE ABOVE INFECTION. A REVISION OF RIGHT THA DUE TO INFECTION FOLLOWING A DAIR WAS PERFORMED. PATIENT STILL HAD INFECTION AND REQUIRED FIRST STAGE REVISION TO REMOVE ALL COMPONENTS, WASH OUT AND DEBRIDEMENT. CEMENTED A 52 LINER AND SIZE 1 C STEM PLACED FOR APPROXIMATELY 6 WEEKS, AND WILL THEN FULLY REVISE.
Patient problems: Unspecified Infection
MAUDE report 21138852 ↗InjuryJan 9, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE SURGEONS SUSPECTED THAT THE CUP WAS LOOSE CAUSING THE PATIENT PAIN. ON (B)(6) 2024, THE CUP, LINER, AND HEAD WERE REVISED. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 21114130 ↗InjuryDec 26, 2024Adverse 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 INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21021014 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, THAT PREVIOUSLY IMPLANTED COMPONENTS WERE ALL REMOVED, DUE TO AN INFECTION IN THE PATIENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 20857297 ↗InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD INSTABILITY IN PACU. DISLOCATING, UNABLE TO CLOSED REDUCE. THE PATIENT WAS TAKEN BACK IN, REMOVED ALL IMPLANTS AND WENT UP IN SIZE AND CONVERTED TO DM. IT WAS MORE THAN 8 HOURS FROM ORIGINAL SURGERY-NO INITIAL INGROWTH, INITIAL FIXATION SEEMED GOOD. CHANGED CUP ANGLE WITH NEW CUP. NO OTHER INFORMATION KNOWN. NO DELAY. NO IMPLANT FAILURE. DOI-(B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 20825405 ↗InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT LEFT HIP WAS REVISED ON (B)(6) 2024 DUE TO PAIN. DATE OF IMPLANT (B)(6) 2023.
Patient problems: Pain
MAUDE report 20633109 ↗InjuryOct 8, 2024Adverse 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 INFECTION. PATIENT UNDERWENT REMOVAL PROCEDURE ON (B)(6) 2024.
Patient problems: Unspecified Infection
MAUDE report 20403297 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- BIOLOX DELTA 1365-40-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented145 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.
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