PINNACLE 1217-08-500Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE CANCELLOUS BONE SCREW 6.5mm x 8mm · Class 2 · Implant
All models of PINNACLE (182)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295008972), received between May 9, 2022 and Aug 18, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Osseointegration Problem1
Patient problems
- Pain2
- Unspecified Infection2
- Bone Fracture(s)1
- Foreign Body Reaction1
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
- Inadequate Osseointegration1
- Inflammation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING CAME OUT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 22828155 ↗InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? -NO. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? -NO.
Patient problems: Pain
MAUDE report 19665826 ↗InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT HIP WAS EXPLANTED FOR INFECTION. TEMPORARY SPACER WAS PUT IN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 16488216 ↗InjuryMay 9, 2022Osseointegration Problem; Osseointegration Problem
LITIGATION RECORD RECEIVED. LITIGATION ALLEGES THAT THE PATIENT WAS DIAGNOSED WITH FIBROADIPOSE TISSUE AND FOCAL SYNOVIUM WITH CHRONIC INFLAMMATION, HEMOSIDEROSIS AND METALLOSIS. DOI: (B)(6) 2017, DOR: (B)(6) 2017, RIGHT HIP (SECOND REVISION).
Patient problems: Bone Fracture(s); Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inadequate Osseointegration; Inflammation; Pain
MAUDE report 14336367 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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