DJO SURGICAL 425-97-010Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 10 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical TaperFill hip stem is an implant used in hip replacement surgery. The 36 reports mostly describe a stem that loosens in the bone, or a break in the stem or the bone around it, which in several cases led to a second operation. Reports also mention falls and joint looseness. There are no deaths, and 36 injuries. 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
- 37
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888912078689), received between Feb 14, 2017 and Sep 25, 2026 — classified as 37 injuries.
The most frequently reported specific device problem is “Fracture” (7 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 Problem17
- Fracture7
- Loosening of Implant Not Related to Bone-Ingrowth7
- Appropriate Device Problem Term/Code Not Available5
- Device Contamination with Chemical or Other Material1
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
- Unintended Movement1
Patient problems
- Joint Laxity9
- Bone Fracture(s)8
- Fall6
- No Code Available4
- Insufficient Information2
- Limb Fracture2
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection2
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Fracture
Patient problems: Periprosthetic fracture
MAUDE report 50892498 ↗InjuryJul 8, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryApr 22, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryMar 20, 2026Fracture
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 24656426 ↗InjuryMar 11, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 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 22789915 ↗InjuryMay 23, 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 22081448 ↗InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL LOWER BODY COMPONENT AND FRACTURE.
Patient problems: Limb Fracture
MAUDE report 19218428 ↗InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL LOWER BODY COMPONENT AND FRACTURE.
Patient problems: Limb Fracture
MAUDE report 18871691 ↗InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE STEM SUBSIDED AND THEY CHANGED IT OUT ALONG WITH THE LINER AND HEAD.
Patient problems: Joint Laxity
MAUDE report 15793927 ↗InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO STEM MOVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15670290 ↗InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PRIMARY TOTAL HIP REPLACEMENT WAS PERFORMED. SURGERY PROCEEDED ROUTINELY UNTIL FEMORAL STEM WAS IMPLANTED AND SEATED. WITH LAST IMPACT OF THE STEM A FRACTURE OCCURRED AT THE TOP OF THE STEM AND THE FRACTURE SPIRALED PROXIMALLY UP THE FEMUR. LONG STEM FEMORAL IMPLANTS WERE NOT AVAILABLE AND IT WAS DECIDED TO CABLE THE FRACTURE, PLACE A FEMORAL HEAD ON THE STEM AND COME BACK IN 3 DAY TO REVISE THE FEMORAL COMPONENT TO AN EXPERT STEM AND HEAD.
Patient problems: Bone Fracture(s)
MAUDE report 15596944 ↗InjuryAug 4, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT FELL AND CAUSED STEM TO LOOSE. REPLACED THE STEM WITH EXPERT HIP AND DUAL MOBILITY LINEAR.
Patient problems: Fall
MAUDE report 15165407 ↗InjuryNov 22, 2021Device Contamination with Chemical or Other Material
REPORTED INCIDENT - WHEN THE SURGEON PULLED THE STEM OUT OF THE STERILE PACKAGE, A VERY SMALL BLUE, UNIDENTIFIED OBJECT WAS EMBEDDED IN THE POROUS COATING OF THE STEM. AFTER SEVERAL TRIES, HE WAS FINALLY ABLE TO REMOVE THE OBJECT WITH A SMALL NEEDLE NOSED KOCHER. HE INSTRUCTED THE SCRUB TECH TO REMOVE THE OBJECT OFF OF THE FIELD IMMEDIATELY. SCRUB TECH WAS ABLE TO RECOVER THE OBJECT AND HAVE IT SAVED IN A SPECIMEN CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12853473 ↗InjuryOct 26, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PERI-PROSTHETIC FRACTURE.
Patient problems: Insufficient Information
MAUDE report 12699295 ↗InjuryAug 6, 2021Loosening of Implant Not Related to Bone-Ingrowth
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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