Lineage 26000004Recalls & reported problems
Microport Orthopedics Inc. · CERAMIC FEMORAL HEAD 28mm SLT TAPER SHORT NECK · 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 M684260000041), received between Jan 18, 2021 and Feb 8, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
- Insufficient Device Problem Information1
- Noise, Audible1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Metal Related Pathology1
- Osteolysis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, INTRA-ARTICULAR METALLOSIS SECONDARY TO TRUNNION WEAR, OSTEOLYSIS, PSEUDOTUMOR AND PROXIMAL PERI-PROSTHETIC FRACTURE.
Patient problems: Metal Related Pathology; Osteolysis
MAUDE report 18673233 ↗InjuryJan 18, 2021Break; Noise, Audible; Break; Noise, Audible
ALLEGEDLY, PATIENT VISITED THE HOSPITAL ON 12/11 BECAUSE HE HEARD A SQUEAKING NOISE FROM HIS HIP JOINT. THE CERAMIC HEAD WAS CONFIRMED TO BE DAMAGED BY X-RAY PHOTOGRAPHY, SO SURGERY WAS PERFORMED ON (B)(6). IN SURGERY. DAMAGED CERAMIC HEAD AND COMBINED PRODUCT AFJ CUP (PHA03618), DELTA HEAD M (PHA04404), AR15 DEGREE LONG NECK (PHA01244) (USED WITH FRONT TWIST) WAS REPLACED. ADDITIONAL INFORMATION RECEIVED ON 12/28/2020 FROM HIROHITO NAKAYAMA: ADDING NECK AND INSERT LOT NUMBERS, ALSO CONFIRMING REVISION FACILITY. JAPAN-OC-000000092
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11186341 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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