DJO SURGICAL 425-96-011Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, STANDARD, SIZE 11 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912078566), received between Dec 6, 2017 and Mar 2, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Fracture” (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 Problem2
- Appropriate Device Problem Term/Code Not Available2
- Fracture2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Device Dislodged or Dislocated1
- Migration or Expulsion of Device1
- Structural Problem1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
- Fall1
- Insufficient Information1
- Joint Laxity1
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASON
Patient problems: Insufficient Information
MAUDE report 20803014 ↗InjuryApr 29, 2022Migration or Expulsion of Device
REVISION SURGERY - THE FEMUR FRACTURED. THE STEM SUBSIDED. REMOVED AND EXCHANGED OUT THE STEM.
Patient problems: Bone Fracture(s)
MAUDE report 14250929 ↗InjurySep 14, 2020Fracture; Device Dislodged or Dislocated
REVISION SURGERY - PATIENT FELL POST OPERATION AND FRACTURED FEMUR. FRACTURE HEALED BUT STEM SUBSIDED. STEM AND HEAD WERE REMOVED AND REPLACED WITH OTHER PRIMARY COMPONENTS.
Patient problems: Fall
MAUDE report 10528960 ↗InjuryFeb 19, 2020Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT HAD A REVISION DUE TO COMPONENT LOOSENING.
Patient problems: No Code Available
MAUDE report 9729350 ↗InjuryDec 13, 2019Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO FRACTURE OF FEMUR POST OPERATION HAD TO DO REPAIR AND REPLACE FEMUR COMPONENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9466998 ↗InjuryJan 30, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT BEING IN PAIN AND HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8289853 ↗InjuryDec 6, 2017Structural Problem
REVISION SURGERY - DUE TO THE INITIAL TAPERFILL STEM BEGINNING TO SUBSIDE. THE SURGEON REMOVED IT AND PUT IN AN EXPERT REVISION HIP.
Patient problems: Failure of Implant
MAUDE report 7088549 ↗
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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