DJO SURGICAL 425-96-012Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, STANDARD, SIZE 12 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912078573), received between Sep 28, 2016 and Aug 6, 2025 — classified as 14 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 Problem7
- Appropriate Device Problem Term/Code Not Available2
- Device Dislodged or Dislocated2
- Fracture2
- Break1
- Loose or Intermittent Connection1
Patient problems
- Bone Fracture(s)5
- Fall3
- No Code Available3
- Insufficient Information2
- Joint Laxity2
- Failure of Implant1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO STEM WAS DISTALLY POTTED.
Patient problems: Insufficient Information
MAUDE report 22734502 ↗InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGEY - DUE TO PATIENT FELL AND FRACTURED FEMUR.
Patient problems: Bone Fracture(s)
MAUDE report 16301433 ↗InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 14575299 ↗InjuryFeb 11, 2022Device Dislodged or Dislocated
REVISION SURGERY PATIENT HAD AN OLD OTI MODULAR STEM THAT THE NECK HAD DISASSOCIATED. SURGEON REMOVED THE OLD STEM.
Patient problems: Insufficient Information
MAUDE report 13514942 ↗InjurySep 5, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REVISED FOR FRACTURE. THE PATIENT HAD A SIDE PLATE PLACED BY A PREVIOUS SURGEON. THE NEW FRACTURES MADE IT NECESSARY TO REVISE THE WHOLE CONSTRUCT.
Patient problems: No Code Available
MAUDE report 10498120 ↗InjurySep 3, 2020Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL POST OPERATION AND HAD FRACTURE.
Patient problems: Fall
MAUDE report 10488576 ↗InjuryApr 28, 2020Loose or Intermittent Connection
REVISION SURGERY - DUE TO MICRO FRACTURE, STEM SUBSIDED.
Patient problems: Failure of Implant
MAUDE report 10005264 ↗InjuryMay 17, 2018Break
REVISION SURGERY - DUE TO THE PATIENT FALLING OUT OF BED AND BREAKING HIS GREATER TROCHANTER.
Patient problems: Bone Fracture(s); Fall; No Code Available
MAUDE report 7523108 ↗InjuryFeb 9, 2017Device Dislodged or Dislocated
REVISION SURGERY - THE PATIENT HAD A PROCEDURE ON (B)(6) 2017, ON DAY 1 POST OPERATION, THE PATIENT'S HIP DISLOCATED. AFTER CLOSER INSPECTION OF FILM, IT WAS DETERMINED THAT COMBINED ANTEVERSION WAS IN EXCESS OF SAFE BONE. THE CUP, LINER AND STEM WERE EXTRACTED AND REPLACED IN ORDER TO SOLVE THE ISSUE.
Patient problems: No Code Available
MAUDE report 6314556 ↗InjurySep 28, 2016Fracture
REVISION SURGERY - DUE TO THE PATIENT FALLING AND FRACTURING THEIR FEMUR.
Patient problems: Fall
MAUDE report 5983721 ↗
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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