DJO SURGICAL 425-97-011Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 11 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Taperfill hip stem is an implant used in hip replacement. The 23 reports mostly describe revision surgery after the stem loosened, moved, fractured or the joint dislocated, with some falls mentioned. There are no deaths and 23 injuries mentioned. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888912078696), received between Mar 4, 2016 and Sep 2, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Fracture” (6 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 Problem13
- Fracture6
- Appropriate Device Problem Term/Code Not Available5
- Break1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Fall7
- Bone Fracture(s)6
- Joint Laxity6
- No Code Available3
- Joint Dislocation2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Fracture
Patient problems: Bone Fracture(s)
MAUDE report 50575976 ↗InjuryFeb 11, 2026Fracture
InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO ASEPTIC STEM LOOSENING.
Patient problems: Unspecified Infection
MAUDE report 20164370 ↗InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND LOOSENING.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 19056496 ↗InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - POSSIBLE INSTABILITY EXPLANTED STEM AND HEAD AND WENT TO EXP.
Patient problems: Joint Laxity
MAUDE report 18280049 ↗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 18088676 ↗InjuryDec 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY, PATIENT BENT DOWN AFTER SURGERY TO GRAB SOMETHING IN FRIDGE AND FELL, STEM CAME LOOSE AND SHE DISLOCATED.
Patient problems: Fall; Joint Dislocation; Joint Laxity
MAUDE report 15898570 ↗InjuryAug 29, 2022Adverse 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 15315003 ↗InjuryApr 29, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY, DUE TO FEMORAL STEM LOOSENING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14250944 ↗InjuryDec 8, 2020Break; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD A PERIPROSTHETIC FRACTURE. THE SURGEON TOOK THE EXISTING STEM OUT AND THEN PUT IN A DISTAL STEM.
Patient problems: Failure of Implant
MAUDE report 10967990 ↗InjuryMay 26, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND FRACTURED HER FEMUR, PULLED OUT TAPERFILL AND PUT IN EXPERT.
Patient problems: Bone Fracture(s); Fall
MAUDE report 10087689 ↗InjuryMay 18, 2020Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT STARTING TO FALL AND PUT FULL WEIGHT ON HER OPERATIVE LEG. THIS CAUSED THE STEM TO SUBSIDE AND A FRACTURE.
Patient problems: Fall
MAUDE report 10067050 ↗InjuryApr 3, 2020Fracture
REVISION SURGERY - PATIENT FELL, RESULTING IN A PERIPROSTHETIC FEMUR FRACTURE.
Patient problems: Fall
MAUDE report 9921390 ↗InjuryMar 11, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 9818560 ↗InjuryDec 5, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: REVISION WAS DUE TO ACUTE INFECTION. REMOVED ALL IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 9416558 ↗InjuryDec 10, 2018Fracture
REVISION SURGERY - DUE TO A CALCAR FRACTURE / PERI-PROSTHETIC FRACTURE.
Patient problems: No Code Available
MAUDE report 8148827 ↗InjuryMar 14, 2018Fracture
InjuryFeb 20, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT SUBSIDED ABOUT 6 WEEKS POST-OPERATION; THE BONE QUALITY IS POOR. DUE TO SOFT BONE, THE PATIENT NEEDED TO BE REVISED TO A LARGER AND LONGER STEM.
Patient problems: No Code Available
MAUDE report 6343156 ↗InjuryMar 4, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAVING SURGERY ON (B)(6) 2016 AND PATIENT FALLING AFTER SURGERY, THE PARTS (425-97-011 AND 430-99-052) ARE BEING REPLACED. THE REVISION SURGERY DID NOT USE DJO PRODUCTS.
Patient problems: No Code Available
MAUDE report 5480932 ↗
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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