DJO SURGICAL 425-11-010Recalls & reported problems
Encore Medical, L.P. · STEM, HIP, FEMORAL, LINEAR SIZE10 LATERAL (SPCL ORDER) R-NECK · 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 00888912078139), received between Dec 16, 2015 and Aug 9, 2021 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (3 reports).
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
- Fracture3
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Break1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
- 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.
InjuryAug 9, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Insufficient Information
MAUDE report 12298424 ↗InjuryMar 12, 2019Fracture
REVISION SURGERY - DUE TO THE PATIENT HAVING A PERI-PROSTHETIC FRACTURE FROM A FALL. THE SURGEON REMOVED ALL IMPLANTS AND ADDED AN EXPRT BODY AND STEM IMPLANTS WITH UNIPOLAR AND SLEEVE.
Patient problems: Fall
MAUDE report 8413904 ↗InjuryNov 9, 2017Fracture
REVISION SURGERY - DUE TO THE PATIENT HAVING A PERI-PROSTHETIC FRACTURE OF THE FEMUR. THE SURGEON REMOVED THE STEM, HEAD AND ACETABULAR LINER; REPLACED WITH OUR LINER AND USED ANOTHER VENDOR FOR THE STEM AND HEAD.
Patient problems: Failure of Implant
MAUDE report 7014050 ↗InjuryMar 21, 2017Break
REVISION SURGERY - THE TRUNNION BROKE ON THE LINEAR STEM; THE SURGEON HAD TO REMOVE THE STEM AND REPLACED IT WITH ANOTHER VENDORS PRODUCT. HE REMOVED AND REPLACED OUR LINER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6421874 ↗InjuryDec 16, 2015Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT SUSTAINED A PER-PROSTHETIC FRACTURE DUE TO A FALL. THE SURGEON REMOVED THE ORIGINAL HEAD, STEM, SLEEVE AND LINER.
Patient problems: Bone Fracture(s)
MAUDE report 5303700 ↗
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