DJO SURGICAL 425-97-007Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 7 · 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. Reports mostly describe the stem coming loose or fractures around it, often leading to another surgery to replace it. There are 24 reports that name its identifier, including 24 injuries and no deaths. 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 00888912078658), received between Nov 9, 2017 and Nov 18, 2025 — classified as 24 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 Problem12
- Appropriate Device Problem Term/Code Not Available6
- Fracture3
- Loose or Intermittent Connection2
- Break1
- Inadequacy of Device Shape and/or Size1
- Malposition of Device1
- Patient Device Interaction Problem1
Patient problems
- Bone Fracture(s)7
- Joint Laxity6
- Insufficient Information3
- Limb Fracture3
- Failure of Implant2
- Fall2
- No Code Available2
- Discomfort1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DOCTOR DID A PRIMARY TOTAL HIP ON THIS PATIENT ON. THE PATIENT SLIPPED AND FELL AND SUSTAINED A PERIPROSTHETIC FEMUR FRACTURE. DOCTOR REVISED THE HIP. HE REMOVED THE TAPERFILL STEM AND 36 CERAMIC HEAD. HE IMPLANTED AN EXPRT REVISION STEM AND 36 CERAMIC +4 FEMORAL HEAD.
Patient problems: Bone Fracture(s); Fall
MAUDE report 22007090 ↗InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE.
Patient problems: Bone Fracture(s); Limb Fracture
MAUDE report 20413472 ↗InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 7, 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 19265615 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 23, 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 17993135 ↗InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE AND SUBSIDENCE.
Patient problems: Joint Laxity; Limb Fracture
MAUDE report 17592671 ↗InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT PRESENTED IN THE EMERGENCY ROOM AT STATUS POST FALL AT HOME AND WAS DIAGNOSED WITH PERIPROSTHETIC FRACTURE OF THE RIGHT FEMUR. REPRESENTATIVE WAS NOTIFIED ON DATE THAT SURGEON SCHEDULED A REVISION TOTAL HIP. DURING PROCEDURE SURGEON REMOVED THE LOOSE TAPERFILL STEM, 36 FEMORAL HEAD AND +7 OFFSET SLEEVE. HE IMPLANTED A 16X130 EXPRT DISTAL STEM, 65MM LATERAL OFFSET EXPRT PROXIMAL BODY AND A 36MM NEUTRAL DELTA CERAMIC HEAD SINCE A DISTAL FIXATION STEM WAS REQUIRED TO BYPASS THE PERIPROSTHETIC FEMUR FRACTURE. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY ISSUES.
Patient problems: Bone Fracture(s)
MAUDE report 15634144 ↗InjuryJul 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: THE INITIAL STEM SUBSIDED SURGEON REMOVED THE 7 TAPERFILL STEM AND USED A STRYKER REVISION STEM TO REPLACE IT.
Patient problems: Joint Laxity
MAUDE report 14951973 ↗InjuryMar 15, 2022Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO FEMUR FRACTURE AROUND THE STEM.
Patient problems: Insufficient Information
MAUDE report 13775075 ↗InjuryJan 4, 2022Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT FELL AND PRESENTED WITH A FRACTURE JUST BELOW THE LESSER TROCH. SURGEON REMOVED THE TAPERFILL STEM AND CONVERTED TO AN EXPERT HIP.
Patient problems: Insufficient Information
MAUDE report 13161185 ↗InjuryMay 12, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT COMPLAINED OF INSTABILITY AND PAIN. RECENT X-RAYS SHOWED SIGNS OF SUBSIDENCE.
Patient problems: Pain
MAUDE report 11812412 ↗InjurySep 5, 2020Fracture
REVISION SURGERY - PATIENT FELL CREATING FRACTURE.
Patient problems: Bone Fracture(s); Fall
MAUDE report 10498121 ↗InjuryAug 17, 2020Break
InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 2020Appropriate Device Problem Term/Code Not Available
InjuryNov 21, 2019Loose or Intermittent Connection
REVISION SURGERY - PATIENT HAD A STEM THAT SURGEON FELT WAS LOOSE. HE TOOK OUT THE STEM, HEAD, AND LINER AND WENT BACK IN WITH A STEM AND HEAD FROM A DIFFERENT COMPANY. HE REPLACED THE LINER WITH A NEW LINER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9355295 ↗InjuryAug 22, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REVISED THE STEM AND HEAD AFTER PATIENT FRACTURED FEMUR AROUND THE STEM. THE PERIPROSTHETIC FRACTURE WAS REVISED TO AN EXPRT HIP STEM.
Patient problems: Bone Fracture(s)
MAUDE report 8922760 ↗InjuryJul 26, 2018Malposition of Device
REVISION SURGERY - DUE TO THE PATIENT'S STEM NEEDING TO BE REPOSITIONED.
Patient problems: No Information
MAUDE report 7724342 ↗InjuryNov 30, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE STEM BEING LOOSE.
Patient problems: Failure of Implant; No Code Available
MAUDE report 7070630 ↗InjuryNov 9, 2017Inadequacy of Device Shape and/or Size
REVISION SURGERY - THE SURGEON SAW IN POST OPERATIVE X-RAY THAT THE SKIN WAS UNDERSIZED. THE SURGEON THEN REMOVED THE SKIN AND WENT UP IN SIZE.
Patient problems: No Code Available
MAUDE report 7014097 ↗
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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