DJO SURGICAL 425-96-008Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, STANDARD, SIZE 8 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888912078535), received between Dec 27, 2017 and Sep 9, 2026 — classified as 18 injuries.
The most frequently reported specific device problem is “Fracture” (4 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Fracture4
- Appropriate Device Problem Term/Code Not Available3
- Patient Device Interaction Problem1
- Unstable1
Patient problems
- Bone Fracture(s)9
- Joint Laxity4
- Fall2
- Joint Dislocation2
- No Code Available2
- Pain1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bone Fracture(s); Fall
MAUDE report 50702453 ↗InjuryApr 17, 2026Unstable
InjuryMar 13, 2026Patient Device Interaction Problem
InjuryDec 9, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
PATIENT SUSTAINED FRACTURE TO THE LESSER TROCHANTER.
Patient problems: Bone Fracture(s)
MAUDE report 23763827 ↗InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND SUBSIDENCE.
Patient problems: Joint Laxity
MAUDE report 16882502 ↗InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - A PERI-PROSTHETIC FRACTURE OCCURRED WITH THE ORIGINAL PROSTHESIS. THE STEM SUBSIDED AND THE HEAD DISLOCATED.
Patient problems: Bone Fracture(s)
MAUDE report 15544637 ↗InjuryApr 15, 2021Fracture; Appropriate Device Problem Term/Code Not Available
InjuryApr 2, 2020Fracture
REVISION SURGERY - DUE TO PATIENT HAVING A PROSTHESIS FRACTURE.
Patient problems: No Code Available
MAUDE report 9917985 ↗InjuryOct 1, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD THIGH PAIN, STEM AND HEAD REMOVED.
Patient problems: Pain
MAUDE report 9139338 ↗InjuryApr 2, 2019Appropriate Device Problem Term/Code Not Available
InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT FALLING AND FRACTURING THEIR FEMUR AFTER BEING RELEASED FROM THE HOSPITAL.
Patient problems: Bone Fracture(s)
MAUDE report 7920165 ↗InjuryDec 27, 2017Fracture
REVISION SURGERY - DUE TO THE PATIENT HAVING A FRACTURE. THE SURGEON NEEDED TO PUT A LONGER STEM IN.
Patient problems: Bone Fracture(s); No Code Available
MAUDE report 7149234 ↗
Other Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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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