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PINNACLE 1217-12-062Recalls & reported problems

Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS DUOFIX HA ACETABULAR SHELL SECTOR 62mm OD · Class 2 · Implant

All models of PINNACLE (182)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295009214), received between Jan 15, 2020 and Nov 29, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Naturally Worn1

Patient problems

  • Foreign Body Reaction1
  • Hypersensitivity/Allergic reaction1
  • No Code Available1
  • Osteolysis1
  • Pain1
  • Tissue Damage1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT HAS HAD CHRONIC ONGOING INFECTION, AND THE FEMORAL STEM WAS IDENTIFIED AS BEING LOOSE. THE STEM WAS REMOVED, THE CUP AND LINER WERE REMOVED. DOI: 2016, DOR: (B)(6) 2021, RIGHT SIDE.

    Patient problems: Unspecified Infection

    MAUDE report 12882124 ↗
  • InjuryJan 15, 2020Naturally Worn; Naturally Worn

    COMPLAINT DESCRIPTION: PATIENT WAS REVISED DUE TO OSTEOLYSIS. SURGERY WAS DELAYED 10-15 MINUTES TO REMOVE METAL LINER. UPDATE AD 02 APR 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT HIP REPLACEMENT WITH METALLOSIS AND PSEUDOTUMOR. REVISION NOTE REPORTED METALLOSIS, CAPSULITIS, PSEUDOTUMOR, GRANULAR METAL WEAR DEBRIS AROUND THE PROXIMAL FEMUR AND INFERIOR ASPECT OF THE ACETABULUM, OSTEOLYSIS AND IT WAS ALSO MENTION THAT THERE WAS NO EVIDENCE OF LOOSENING. INDICATION NOTE REPORTED PAIN, X-RAYS SHOWED OSTEOLYSIS AROUND THE INFERIOR ASPECT OF THE CUP AND PROXIMAL FEMUR AND WEAR DEBRIS. ADDED STEM AND CUP DUE TO NEW ALLEGATION REPORTED FROM MEDICAL RECORDS. ADDED NEW PATIENT CODE MEDICAL DEVICE REMOVAL; AND PATIENT MEDICAL HISTORY AND UPDATED INITIALS. DOI: (B)(6) 2007 - DOR: (B)(6) 2016 (RIGHT HIP) FIRST REVISION.

    Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Pain; Tissue Damage

    MAUDE report 9591164 ↗

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

All PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices →

Sources and updates

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