Lineage 26012804Recalls & reported problems
Microport Orthopedics Inc. · COCR FEMORAL HEAD 28MM SLT TAPER +7MM NECK · Class 2 · Implant
All models of Lineage (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684260128041), received between Dec 8, 2020 and Nov 14, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Naturally Worn1
Patient problems
- Metal Related Pathology2
- Insufficient Information1
- Osteolysis1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
ALLEGEDLY, A PATIENT WAS SEEN AT HOME AFTER HEARING A STRANGE NOISE WHILE STANDING ON THE TABLE WITH BOTH HANDS ON THE TABLE AND CROUCHING DOWN ON A CHAIR. REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION OF THE BIPOLAR CUP ON X-RAY. INTRAOPERATIVE FINDINGS SHOWED THAT THE RING WAS DISLODGED AND THE CUP WAS DISLODGED. THE PATIENT WAS ASKED TO INVESTIGATE WHY THE RING WAS DISLODGED. SURGERY WAS COMPLETED WITH REPLACEMENT OF THE HEAD AND BIPOLAR CUP. (B)(4).
Patient problems: Insufficient Information
MAUDE report 20686694 ↗InjuryJul 29, 2022Naturally Worn; Naturally Worn
ALLEGEDLY, PATIENT HAS BEEN EXPERIENCING PAIN FROM AROUND 9 MONTHS POST-OP AND BLOOD TESTS SHOWED RAISED METAL ION LEVELS. REVISION WAS PERFORMED TO REMOVE THE ORIGINAL STEM AND 28MM METAL SKIRTED HEAD. THERE IS METAL-ON-METAL WEAR ON THE TRUNNION.
Patient problems: Metal Related Pathology; Osteolysis; Pain
MAUDE report 15131753 ↗InjuryDec 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, METAL COMPONENTS WERE RELEASING DANGEROUS LEVELS OF COBALT (METALLOSIS) COMPONENT FROM ANOTHER MANUFACTURER: ZIMMER TREBACULAR METALACETABULAR REVISION SYSTEM, REF (B)(4), LOT NUMBER 62895935.
Patient problems: Metal Related Pathology
MAUDE report 10969011 ↗
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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