PINNACLE GRIPTION 1217-17-068Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE GRIPTION ACETABULAR SHELL REVISION (DPX) 68mm OD 62 LINER · Class 2 · Implant
All models of PINNACLE GRIPTION (57)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295009528), received between Aug 2, 2018 and Jun 10, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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
- Loose or Intermittent Connection2
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Loss of Osseointegration1
- Migration1
- Osseointegration Problem1
- Use of Device Problem1
Patient problems
- Inadequate Osseointegration4
- Joint Laxity1
- Limited Mobility Of The Implanted Joint1
- No Code Available1
- Not Applicable1
- Pain1
- Tissue Damage1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS INFECTED. ALL COMPONENTS WERE REMOVED. PATIENT HAS MULTIPLE SURGERY DATES, (B)(6) 2020. (B)(6) 2022. (B)(6) 2025. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22175987 ↗InjuryDec 1, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE INSTABILITY AND LOOSED CUP AT THE BONE TO IMPLANT INTERFACE. DON¿T KNOW WHEN OR WHERE WAS IMPLANTED PRIOR, DON¿T HAVE ACCESS TO LOT #S, AND ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT HIP.
Patient problems: Inadequate Osseointegration; Joint Laxity
MAUDE report 10927788 ↗InjuryMar 20, 2019Fracture; Use of Device Problem; Loss of Osseointegration; Fracture; Use of Device Problem; Loss of Osseointegration
PFS ALLEGES PAIN, INSTABILITY, AND RECURRENT ABSCESSES, AND USING CANE FOR MOBILITY. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING. GROSS PATHOLOGY REPORTED OF A LARGE VOLUME SYNOVIAL FLUID WITH CONSISTENT SYNOVITIS, METALLOSIS, METALLIC DEBRIS, BROKEN RIM FIT SCREW ONLY ONE OF FOUR SCREW , GROSS LOOSENING OF CUP. OPERATIVE REPORT CUP HAD A VERTICAL ALTITUDE WITH GROSS ANTEVERSION AND HAD MIGRATED. LOOSENING CONFIRMED. ONE BROKEN SCREW WERE READILY IDENTIFIED AS BROKEN INVOLVING THE LIPPED PORTION OF THE CUP AND DEMONSTRATED WITH GROSS METALLOSIS AND GRAY STAINED. DOI: (B)(6) 2012; DOR: (B)(6) 2014; (RIGHT HIP).
Patient problems: Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage
MAUDE report 8435669 ↗InjuryAug 6, 2018Loose or Intermittent Connection; Migration; Loose or Intermittent Connection; Migration
PATIENT WAS REVISED TO ADDRESS SUPERIOR MIGRATION OF THE CUP. IT WAS ALSO INDICATED THAT THE CUP WAS LOOSE AT BONE TO IMPLANT INTERFACE. THE CONSTRUCT WAS REPLACED WITH A TF AUGMENT AND MULTIHOLE GRIPTION CUP. DOI: 2017; DOR: (B)(6) 2018; LEFT HIP.
Patient problems: Inadequate Osseointegration; Not Applicable
MAUDE report 7751671 ↗InjuryAug 2, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP AND COMPONENT FRACTURE . DOI: (B)(6) 2008; DOR: NOT REPORTED (RIGHT HIP).
Patient problems: Inadequate Osseointegration
MAUDE report 7742177 ↗
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
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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