DJO SURGICAL 425-97-006Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 6 · 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 00888912078641), received between Jan 30, 2019 and Nov 10, 2025 — classified as 17 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
- Adverse Event Without Identified Device or Use Problem11
- Appropriate Device Problem Term/Code Not Available4
- Fracture3
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Positioning Problem1
Patient problems
- Joint Laxity7
- Fall2
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
- Bone Fracture(s)1
- Hip Fracture1
- Implant Pain1
- Pain1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - FALL LOWER BODY COMPONENT/FRACTURE.
Patient problems: Fall; Hip Fracture
MAUDE report 18088701 ↗InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 8, 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 17716364 ↗InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PERIPROSTHETIC FRACTURE OF THE STEM. THE STEM AND HEAD WERE REPLACED WITH IMPLANTS. THE POLY WAS SWAPPED OUT.
Patient problems: Bone Fracture(s)
MAUDE report 14575304 ↗InjuryMar 1, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT PRESENTED WITH HIP PAIN, SPECIFICALLY THIGH PAIN.
Patient problems: Pain
MAUDE report 13635852 ↗InjuryNov 30, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL ON HER HIP AFTER GETTING HER PRIMARY HIP DONE FRACTURED IT AND NEEDED TO PUT A REVISION STEM IN.
Patient problems: Fall
MAUDE report 12902144 ↗InjuryOct 27, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT SUFFERED A PERI-PROSTHETIC FRACTURE OF HER PROXIMAL FEMUR THAT REQUIRED A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 12705327 ↗InjuryJul 3, 2020Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - FEMORAL PERIPROSTHETIC FRACTURE.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 10229727 ↗InjuryMay 30, 2019Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO SUSPICION THAT THE STEM WAS LOOSE. THE SURGEON REMOVED THE STEM, HEAD, AND LINER. THE STEM AND HEAD WERE REPLACED WITH DEPUY IMPLANTS. THE LINER WAS REPLACED WITH DJO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8655158 ↗InjuryJan 30, 2019Loose or Intermittent Connection; Positioning Problem
REVISION SURGERY - DUE TO A SMALLER STEM THAN NECESSARY, THE PATIENT'S HIP DISLOCATED. THE PATIENT HAD THEIR HIP REPLACED WITH NO COMPLICATIONS DURING THE PRIMARY SURGERY. THE SURGEON PERFORMED THE REVISION SURGERY, REPLACING THE STEM AND LINER AND FEMORAL HEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8289884 ↗
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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