DJO SURGICAL 425-99-014Recalls & reported problems
Encore Medical, L.P. · Linear, Lateral, Reduced Neck, Sz 14, W/P2 Coating · Class 2 · Implant
Data updated Oct 18, 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 00888912079013), received between Jun 29, 2022 and Sep 28, 2022 — classified as 3 injuries.
1 other recall cover devices cleared under the same FDA submission (K120241); they may or may not involve this specific model.
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 Problem3
Patient problems
- Bone Fracture(s)2
- Fall1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE SURGEON CRACKED THE FEMUR WHILE IMPLANTING THE LINEAR STEM, SO HE HAD TO REMOVE THE STEM AND USE EXPERT IMPLANTS TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15497991 ↗InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PERI-PROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 14888670 ↗InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT SUSTAINED A FALL WHICH RESULTED IN A PERIPROSTHETIC FRACTURE OF THE FEMUR WHICH REQUIRED REVISION TO AN EXPERT REVISION STEM. SURGEON REMOVED TO LINEAR STEM, 28MM DELTA HEAD AND THE DUAL MOBILITY BEARING AND REPLACED THEM.
Patient problems: Bone Fracture(s); Fall
MAUDE report 14856508 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K120241. One submission often covers many models, so check the product and lot details in each record.
- Z-1692-2020 · Jul 10, 2018 · Open, Classifieddjosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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