DJO SURGICAL 425-96-007Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, STANDARD, SIZE 7 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888912078528), received between Jun 25, 2016 and May 21, 2026 — classified as 11 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 Problem6
- Fracture3
- Appropriate Device Problem Term/Code Not Available1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Unstable1
Patient problems
- Bone Fracture(s)4
- Fall2
- Joint Laxity2
- Failure of Implant1
- Joint Dislocation1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryApr 3, 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 21770251 ↗InjuryMar 31, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL LOWER BODY/DISLOCATION.
Patient problems: Fall; Joint Dislocation
MAUDE report 21735599 ↗InjuryMar 14, 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 21612869 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - METASTATIC LESION AND SUBSIDENCE SO CEMENTED A LONG REVISION STEM.
Patient problems: Joint Laxity
MAUDE report 15873031 ↗InjuryFeb 8, 2021Appropriate Device Problem Term/Code Not Available
InjuryMay 18, 2020Fracture
REVISION SURGERY - DUE TO PATIENT HAVING A DOCUMENTED FALL AFTER THE INTIAL SURGERY WHICH RESULTED IN A PERIPROSTHETIC FRACTURE. SHE NEEDED TO BE REVISED TO FIX THE FRACTURE.
Patient problems: Fall
MAUDE report 10067051 ↗InjuryJan 7, 2020Fracture
REVISION SURGERY - DUE TO PERIPROSTHETIC FEMORAL FRACTURE.
Patient problems: Failure of Implant
MAUDE report 9558905 ↗InjuryJun 25, 2016Fracture
REVISION SURGERY - DUE TO THE STEM SUBSIDING AND A PERIPROSTHETIC FRACTURE. IT IS UNCLEAR WHETHER THE STEM SUBSIDED AS A RESULT OF THE FRACTURE OR IF THE SUBSIDENCE CAUSED THE FRACTURE.
Patient problems: No Code Available
MAUDE report 5749760 ↗
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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