Quadra H femoral stems 01.12.35SNRecalls & reported problems
Medacta International SA · QUADRA "H" Short neck, cem.less, lat, HAP S. 5 · Class 2 · Implant
All models of Quadra H femoral stems (32)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030802751), received between Feb 19, 2021 and Sep 1, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
1 other recall cover devices cleared under the same FDA submission (K093944, K250450); they may or may not involve this specific model.
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
- Fracture1
- Loose or Intermittent Connection1
- Osseointegration Problem1
Patient problems
- Aseptic loosening1
- Fall1
- Implant Pain1
- Inadequate Osseointegration1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2026Osseointegration Problem
Patient problems: Aseptic loosening; Implant Pain
MAUDE report 50543230 ↗InjuryMar 9, 2022Fracture; Fracture
REVISION SURGERY WAS PERFORMED 7 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY BECAUSE OF A STEM NECK FRACTURE AFTER THE PATIENT FELL (WALKING TO THE BATHROOM, TURNED HIS LEG AND FELL). STEM BODY AND CUP WERE SOLIDLY ATTACHED, CUP AND STEM WERE RETROVERTED. STEM, TRUNNION, AND ACETABULAR COMPONENTS WERE REMOVED. THE ACETABULAR COMPONENT WAS REMOVED TO ALLOW THE INSERTION OF A LARGER COMPONENT.
Patient problems: Fall
MAUDE report 13706924 ↗InjuryFeb 19, 2021Loose or Intermittent Connection
THE PATIENT CAME IN REPORTING PAIN. THE POST-OP X-RAYS INDICATED THAT ASEPTIC LOOSENING OF THE STEM HAD OCCURRED. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS, AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 1 YEAR AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 11347290 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K093944, K250450. One submission often covers many models, so check the product and lot details in each record.
- Z-0791-2013 · Dec 17, 2012 · TerminatedMedacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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