DJO SURGICAL 425-99-011Recalls & reported problems
Encore Medical, L.P. · Linear, Lateral, Reduced Neck, Sz 11 W/P2 Coating · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912078979), received between Nov 16, 2017 and Mar 7, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Fracture” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
- Fracture3
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
- Unstable1
Patient problems
- Bone Fracture(s)2
- Fall2
- Joint Laxity2
- Insufficient Information1
- Limb Fracture1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT SUSTAINED A FALL WHICH CAUSED A PERIPROSTHETIC FRACTURE OF THE FEMUR WHICH REQUIRED A REVISION SURGERY.
Patient problems: Fall; Joint Laxity
MAUDE report 21554679 ↗InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE AND SUBSIDENCE.
Patient problems: Joint Laxity; Limb Fracture
MAUDE report 17446676 ↗InjuryJul 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT DEVELOPED A FEMUR FRACTURE POST-OPERATIVELY. SURGEON ELECTED TO REMOVE THE LINEAR SYSTEM, CABLE THE FEMUR, AND IMPLANT AN EXPERT STEM. THE 28MM HEAD AND POLY BEARING OF THE DUAL MOBILITY WERE ALSO EXPLANTED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Bone Fracture(s)
MAUDE report 14951964 ↗InjuryApr 18, 2022Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PROSTHETIC FRACTURE.
Patient problems: Insufficient Information
MAUDE report 14137583 ↗InjuryOct 30, 2020Fracture
InjuryOct 8, 2020Appropriate Device Problem Term/Code Not Available
InjuryMay 26, 2020Fracture
REVISION SURGERY - DUE TO PERI PROSTHETIC FRACTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10087660 ↗InjuryNov 16, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF PAIN. THE SURGEON FOUND OUT THAT THE STEM HAD SUBSIDED.
Patient problems: Pain
MAUDE report 7038204 ↗
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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