PINNACLE ALTRX 1221-44-464Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE HIP SOLUTIONS ALTRX LD POLYETHYLENE ACETABULAR LINER +4 NEUTRAL 44mm ID 64mm OD · Class 2 · Implant
All models of PINNACLE ALTRX (98)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295016670), received between Dec 18, 2018 and Apr 8, 2020 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.
Most reported problems
Device problems
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Joint Dislocation5
- No Code Available3
- Limited Mobility Of The Implanted Joint1
- Pain1
- Tissue Damage1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PFS ALLEGES THAT THE PATIENT CONTINUES TO EXPERIENCE PAIN AND DECREASED MOBILITY. DOI: (B)(6) 2013. DOR: NO REVISION REPORTED, (RIGHT HIP).
Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain
MAUDE report 9935799 ↗InjuryMar 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED FOR DISLOCATION. EXTRACTED THE FEMORAL HEAD AND LINER. IMPLANTED A 40MM ARTICULEZE HEAD AND 64 X 40 +4 NEUTRAL CONSTRAINED LINER.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 9860568 ↗InjuryApr 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
LITIGATION ALLEGES DISLOCATION AFTER 1ST REVISION. DOI: (B)(6) 2014, DOR: NONE REPORTED, (LEFT HIP).
Patient problems: Joint Dislocation
MAUDE report 8522329 ↗InjuryMar 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES PSEUDOTUMOR, CONSTRAINED LINER, ABDUCTOR MUSCLE REPAIR, DISLOCATION WITH OPEN REDUCTION AND ELEVATED METAL IONS AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO OPERATIVE NOTE PROVIDE FOR THE SECOND REVISION. THE POLYETHYLENE LINER, CERAMIC HEAD, AND THE STEM WERE REPORTED TO THE IMPACTED PRODUCT DUE TO THE PPF ALLEGATION. DOI: (B)(6) 2012 - DOR: (B)(6) 2013 (RIGHT HIP) SECOND REVISION.
Patient problems: Joint Dislocation; No Code Available; Tissue Damage
MAUDE report 8416493 ↗InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PPF ALLEGES DISLOCATION AND INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2015 - DOR: NONE REPORTED (LEFT HIP). SEE (B)(4) FOR THE FIRST REVISION.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 8181168 ↗InjuryDec 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
LITIGATION ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION.
Patient problems: Joint Dislocation
MAUDE report 8175772 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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