DJO SURGICAL 425-97-016Recalls & reported problems
Encore Medical, L.P. · TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 16 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912078740), received between Apr 7, 2022 and Jul 9, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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 Problem3
- Fracture1
Patient problems
- Bone Fracture(s)3
- Fall2
- Joint Dislocation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL IN REHAB AND BROKE HER FEMUR.
Patient problems: Bone Fracture(s); Fall
MAUDE report 25772728 ↗InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - UPON WEIGHT BEARING, THE PATIENT SUSTAINED A PERI PROSTHETIC FRACTURE AND DISLOCATION OF THE HIP. SURGEON REVISED THE HIP AND REMOVED THE SIZE 16 LATERAL TAPERFILL STEM, 40 HEAD AND NEUTRAL OFFSET SLEEVE. SURGEON PLACED A CABLE TO FIX THE FRACTURE AND IMPLANTED A SIZE17 LATERAL TAPERFILL STEM, 40 HEAD AND +10.5MM OFFSET SLEEVE.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 18229381 ↗InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 7, 2022Fracture
REVISION SURGERY: PATIENT WAS REPORTED TO HAVE FALLEN AND SUFFERED A PERIPROSTHETIC FRACTURE OF THE FEMUR.
Patient problems: Fall
MAUDE report 14044063 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page