DJO SURGICAL 425-97-005Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 5 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912078634), received between Sep 1, 2017 and Mar 12, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Fracture” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Fracture4
- Appropriate Device Problem Term/Code Not Available3
- Loose or Intermittent Connection2
- Break1
- Inadequacy of Device Shape and/or Size1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Bone Fracture(s)4
- Fall3
- Insufficient Information2
- Joint Laxity2
- No Code Available2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Limb Fracture1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryMar 12, 2026Fracture
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 24587607 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - FEMORAL ONLY REVISION, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24373557 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FALL LOWER BODY/FRACTURE.
Patient problems: Bone Fracture(s); Fall; Limb Fracture
MAUDE report 21108233 ↗InjuryAug 12, 2024Adverse 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
InjuryMay 6, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FRACTURED FEMUR POST OPERATION. SURGEON REMOVED OUR STEM AND REPLACED WITH A ZIMMER WAGER STEM.
Patient problems: Bone Fracture(s)
MAUDE report 14307061 ↗InjuryDec 17, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO LOOSE FEMORAL STEM.
Patient problems: Insufficient Information
MAUDE report 13030237 ↗InjuryNov 29, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO PATIENT FELL. PERIPROSTHETIC FRACTURE. SIZE 5 LATERAL STEM CAME OUT WITH THE 28MM HEAD AND DUAL MOBILITY LINER.
Patient problems: Fall
MAUDE report 12882831 ↗InjuryDec 18, 2020Fracture; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - GREATER TROCHANTER FRACTURE, LOOSE STEM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11037234 ↗InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: REMOVED POST INFECTION HAD CLEARED.
Patient problems: Unspecified Infection
MAUDE report 9694122 ↗InjuryOct 4, 2018Break
REVISION SURGERY - DUE TO THE PATIENT FALLING AND BREAKING THEIR FEMUR. HAD TO GO IN AND REPLACE.
Patient problems: Fall
MAUDE report 7935058 ↗InjuryNov 30, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE STEM BEING LOOSE.
Patient problems: No Code Available
MAUDE report 7070567 ↗InjuryNov 3, 2017Fracture
REVISION SURGERY - DUE TO THE PATIENT HAVING A CALCAR FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 6999640 ↗InjurySep 1, 2017Inadequacy of Device Shape and/or Size
REVISION SURGERY - DUE TO THE STEM SUBSIDING BECAUSE THE SURGEON PUT IN TOO SMALL A STEM.
Patient problems: No Code Available
MAUDE report 6840414 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page