Entrada Hip Stem 510-0213Recalls & reported problems
Ortho Development Corporation · Size 13 STD Collar · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822409035984), received between Mar 3, 2021 and Jan 8, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Problem1
- Device Dislodged or Dislocated1
Patient problems
- Arthralgia1
- Joint Dislocation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT RECEIVED TOTAL HIP ARTHROPLASTY. POSTOPERATIVE X-RAYS SHOWED A PERFORATED FEMUR AT THE DISTAL TIP OF THE STEM SO THE PATIENT WAS REOPENED. THE STEM WAS REALIGNED AND CORRECT PLACEMENT WAS CONFIRMED WITH INTRAOPERATIVE IMAGING.
Patient problems: Arthralgia
MAUDE report 21106427 ↗InjuryMar 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
A TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2021. DURING POSTOPERATIVE X-RAY, THE HIP DISLOCATED AND MANIPULATION WAS INSUFFICIENT TO RESTORE THE JOINT. THE INCISION WAS REOPENED, THE STEM REMOVED, AND ADDITIONAL BROACHING WAS PERFORMED. IN THE END, THE SURGEON REPLACED THE STEM WITH A DIFFERENT MODEL TO REDUCE THE POTENTIAL FOR DISLOCATION. THE SURGEON INDICATED THIS WAS NOT A PRODUCT ISSUE.
Patient problems: Joint Dislocation
MAUDE report 11408303 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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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