DJO SURGICAL 425-99-006Recalls & reported problems
Encore Medical, L.P. · Linear, Lateral, Reduced Neck, Sz 6, W/P2 Coating · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912078924), received between May 5, 2017 and Dec 29, 2023 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (2 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 Available2
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- Bone Fracture(s)2
- Fall1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 23, 2021Fracture
REVISION SURGERY - DUE TO PROSTHETIC FRACTURE.
Patient problems: Insufficient Information
MAUDE report 12356080 ↗InjuryJul 29, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT FELL AND SUFFERED FRACTURE.
Patient problems: Fall
MAUDE report 12249869 ↗InjuryJul 16, 2021Appropriate Device Problem Term/Code Not Available
InjuryMay 5, 2017Use of Device Problem
PRIMARY SURGERY - THE SURGEON COUNTER SUNK A SIZE 6 BROACH; UPON IMPLANTING THE SAME SIZE STEM IT WAS PROUD 4-5 MM. IT CHANGED THE LEG LENGTH BY A LARGE MARGIN, THE SURGEON WANTS A FOLLOW UP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6547473 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page