DJO SURGICAL 425-97-012Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 12 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912078702), received between Apr 3, 2019 and Oct 15, 2025 — classified as 17 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 Problem8
- Appropriate Device Problem Term/Code Not Available4
- Fracture2
- Loose or Intermittent Connection2
- Device Dislodged or Dislocated1
- Implant subsidence1
- Unstable1
Patient problems
- Fall6
- Bone Fracture(s)4
- Joint Dislocation2
- Joint Laxity2
- Aseptic loosening1
- Failure of Implant1
- Implant Pain1
- Loss of Range of Motion1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Implant subsidence; Implant subsidence
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO STEM SUBSIDENCE. THE PATIENT WAS REVISED USING THE EXPRT HIP SYSTEM.
Patient problems: Aseptic loosening
MAUDE report 23286016 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PERI-PROSTHETIC FRACTURE AFTER FALL.
Patient problems: Bone Fracture(s); Fall
MAUDE report 22367413 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND BROKE HIS FEMUR.
Patient problems: Bone Fracture(s); Fall
MAUDE report 22023650 ↗InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND HAD A FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 19495029 ↗InjuryApr 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENTS STEM SUBSIDED.
Patient problems: Loss of Range of Motion
MAUDE report 19103052 ↗InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY. SURGEON TOOK ALL PREVIOUS IMPLANTS OUT.
Patient problems: Joint Laxity
MAUDE report 15739747 ↗InjuryApr 13, 2022Unstable
COMPLAINT - SURGEON TRIALED WITH THE BROACH SIZE THAT WAS APPROPRIATE FOR THE PATIENT. WHEN THE IMPLANT WAS PLACED IT SUBSIDED CAUSING THE HIP TO BE UNSTABLE. IMPLANTS HAD TO BE TAKEN OUT AND REPLACED.
Patient problems: Joint Laxity
MAUDE report 14105056 ↗InjuryMay 28, 2021Loose or Intermittent Connection
REVISION SURGERY - THE PATIENT FELL OUT OF BED AND DISLOCATED HER HIP. SURGEON ATTEMPTED A CLOSED REDUCTION, BUT WAS UNABLE TO REDUCE THE HIP. HE OPENED THE HIP AND THE STEM WAS LOOSE AND DECIDED TO GO TO ONE STEM LARGER.
Patient problems: Fall; Joint Dislocation
MAUDE report 11901608 ↗InjuryDec 19, 2019Fracture
REVISION SURGERY - PATIENT FELL AFTER HAVING A BIPOLAR HIP FRACTURE REPAIR DONE, CAUSING ANOTHER FRACTURE TO TAKE PLACE.
Patient problems: Fall
MAUDE report 9496995 ↗InjuryDec 17, 2019Fracture
InjurySep 25, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO STEM LOOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9120367 ↗InjuryAug 16, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - NECK DISASSOCIATED FROM LINER.
Patient problems: Failure of Implant
MAUDE report 8903240 ↗InjuryAug 2, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT FELL DOWN AND FRACTURED HER FEMUR POST-OPERATION.
Patient problems: Bone Fracture(s); Fall
MAUDE report 8856132 ↗InjuryMay 10, 2019Appropriate Device Problem Term/Code Not Available
InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem
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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