DJO SURGICAL 425-96-009Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, STANDARD, SIZE 9 · 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 00888912078542), received between Mar 21, 2017 and Sep 16, 2026 — classified as 14 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 Problem6
- Appropriate Device Problem Term/Code Not Available2
- Fracture2
- Loose or Intermittent Connection2
- Device Dislodged or Dislocated1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Positioning Problem1
- Unstable1
Patient problems
- Joint Laxity4
- Bone Fracture(s)3
- Failure of Implant2
- Fall2
- Insufficient Information2
- No Code Available2
- Joint Dislocation1
- Limb Fracture1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50796565 ↗InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 21590369 ↗InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 17, 2024Adverse 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
InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO FRACTURE DUE TO FALL IN SHOWER.
Patient problems: Bone Fracture(s)
MAUDE report 16456458 ↗InjuryAug 17, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT RECEIVED TOTAL HEAD ARTHROPLASTY AND THEN FELL RESULTING IN A PERI PROSTHETIC HIP FRACTURE. SURGEON REMOVED THE PRIMARY HIP STEM AND HEADBALL - REPLACED THOSE WITH AN EXPRT STEM AND BODY ALONG WITH A NEW HEADBALL.
Patient problems: Bone Fracture(s); Fall
MAUDE report 15243279 ↗InjuryJul 2, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PERI PROSTHETIC FRACTURE OCCURRED DAY AFTER INITIAL SURGERY. THE TAPERFILL STEM AND CERAMIC HEAD WERE REMOVED AND REPLACED WITH AN EXPERT HIP STEM AND NEW CERAMIC HEAD.
Patient problems: Insufficient Information
MAUDE report 12110346 ↗InjuryMay 19, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD THIGH PAIN AND THE SURGEON SUSPECTED THE STEM TO BE LOOSE. STEM WAS SECURELY IN PLACE. REMOVED HEAD, STEM, AND LINER. REPLACED WITH A DJO LINER. REPLACED STEM AND HEAD WITH ANOTHER VENDOR.
Patient problems: Insufficient Information
MAUDE report 11852795 ↗InjuryJul 28, 2020Loose or Intermittent Connection
REVISION SURGERY - STEM SUBSIDED.
Patient problems: Failure of Implant; No Code Available
MAUDE report 10332162 ↗InjuryFeb 26, 2019Fracture
REVISION SURGERY - DUE TO A FRACTURE DUE TO A FALL.
Patient problems: Failure of Implant; Fall
MAUDE report 8370865 ↗InjuryDec 17, 2018Positioning Problem
REVISION SURGERY - A LATERIZED OFFSET STEM WAS NEEDED.
Patient problems: No Code Available
MAUDE report 8172042 ↗InjuryMar 21, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT'S PROSTHESIS HAVING DISLOCATED POST OPERATION. THE PATIENT WAS BROUGHT BACK TO SURGERY AND THE REVISION WAS PERFORMED TO REMOVE 425-96-009, REPLACING IT WITH 425-97-011.
Patient problems: Joint Dislocation
MAUDE report 6420992 ↗
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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