Lineage 364132X2Recalls & reported problems
Microport Orthopedics Inc. · LINEAGE® A-CLASS® 32MM 0DG GROUP 2 CROSSLINKED POLY LINER · Class 2 · Implant
All models of Lineage (35)
Data updated Oct 16, 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 M684364132X21), received between Feb 22, 2021 and Jan 6, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Separation Failure” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Separation Failure1
Patient problems
- Pain1
- Unequal Limb Length1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2022Appropriate Device Problem Term/Code Not Available
SAE# (B)(4). ALLEGEDLY, THE PATIENT STARTED HAVING LT HIP PAIN 3 WEEKS AFTER SURGERY. MULTIPLE ATTEMPTS TO RELIEF THE PAIN WITH CORTICOSTEROID INJECTIONS INTRA-ARTICULAR WITH NO SUCCESS. THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR RELEASE OF THE PSOAS TENDON ON (B)(6) 2018. THE PAIN AND WEAKNESS IN THE LEFT THIGH IS STILL PERSISTENT. ADDITIONAL INFORMATION FROM CLINICAL RECEIVED ON 26/10/2021 CONFIRMING THAT COMPONENTS WERE NOT REVISED.
Patient problems: Pain
MAUDE report 13178679 ↗InjuryFeb 22, 2021Separation Failure
ALLEGEDLY, THE PATIENT WAS REVISED DUE TO LEG LENGTH DISCREPANCY OF ABOUT 4MM ON THE RIGHT SIDE. RADIOGRAPHIC IMAGES SHOWED POSSIBLE LOOSENING OF CUP AND STEM. THE REVISION WAS SCHEDULED TO REPLACE THE HEAD AND NECK AND POSSIBLY THE LINER. WHEN TRYING TO REMOVE THE NECK FROM THE STEM, IT COULD NOT BE SEPARATED. SO THE STEM WAS ALSO REMOVED. ADDITIONAL INFORMATION RECEIVED ON 02/02/2021: REVISED PART AND LOT NUMBERS WERE PROVIDED AS WELL AS THE REASON FOR REVISION, MOREOVER THE REVISION SURGERY DATE.
Patient problems: Unequal Limb Length
MAUDE report 11357925 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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