Quadra H femoral stems 01.12.037Recalls & reported problems
Medacta International SA · QUADRA Stem Quadra Laterized HAP 12/14 S7 · 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 07630030802195), received between Jun 3, 2022 and May 14, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).
1 other recall cover devices cleared under the same FDA submission (K082792, 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
- Appropriate Device Problem Term/Code Not Available1
- Failure to Osseointegrate1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration2
- Bone Fracture(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AT ABOUT 10 YEARS 9 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FEMORAL FRACTURE. THE CAUSE OF THE FEMORAL FRACTURE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 22016284 ↗InjuryApr 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
REVISION SURGERY DUE TO ASEPTIC LOOSENING AT ABOUT 5 YEARS 2 MONTHS FROM PRIMARY. SURGERY COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 21854181 ↗InjuryJun 3, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY PERFORMED DUE TO STEM LOOSENING, 6 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY.
Patient problems: Inadequate Osseointegration
MAUDE report 14591435 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K082792, 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/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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