DJO SURGICAL 425-96-013Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, STANDARD, SIZE 13 · 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 00888912078580), received between May 7, 2019 and Oct 3, 2023 — 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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
- Fall1
- Insufficient Information1
- No Code Available1
- 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.
InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO FALL LOWER BODY COMPONENT.
Patient problems: Insufficient Information
MAUDE report 17866047 ↗InjuryJun 24, 2022Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AFTER POST-OPERATION, IN THE HOSPITAL AND HAD A PERIPROSTHETIC FRACTURE. THE FEMORAL COMPONENT HAD TO BE REVISED.
Patient problems: Fall
MAUDE report 14809388 ↗InjuryApr 13, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT FRACTURED THEIR FEMUR AND NEEDED A LONGER STEM.
Patient problems: Bone Fracture(s)
MAUDE report 11659502 ↗InjuryJul 24, 2020Fracture
REVISION SURGERY - FRACTURED THE FEMUR DISTALLY AS WE PUT THE TAPERFILL STEM IN. HAD TO SWITCH TO REVISION HIP.
Patient problems: No Code Available
MAUDE report 10319782 ↗InjuryMay 7, 2019Fracture
REVISION SURGERY - DUE TO THE SURGEON BELIEVING THAT THE PATIENT HAD A FRACTURE DURING THE PRIMARY CASE AND THE PATIENT BROKE FEMUR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8587981 ↗
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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