Quadra C femoral stems 01.12.044Recalls & reported problems
Medacta International SA · Quadra C Cemented Standard stem size 4 · Class 2 · Implant
All models of Quadra C femoral stems (11)
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 07630030802256), received between Jul 22, 2020 and Dec 23, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
1 other recall cover devices cleared under the same FDA submission (K083558); 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.
Most reported problems
Device problems
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Disorder1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 23, 2021Loose or Intermittent Connection
REVISION SURGERY WAS PERFORMED 2 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION. THE PATIENT ISN´T A SPORTY PERSON. USES CRUTCHES FOR YEARS, PUTS LITTLE STRAIN ON THE LEG.
Patient problems: Joint Laxity
MAUDE report 13078028 ↗InjuryJul 22, 2020Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY PERFORMED DUE TO STEM SUBSIDENCE 1 YEAR AND 6 MONTHS AFTER PRIMARY.
Patient problems: Joint Disorder
MAUDE report 10307068 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083558. 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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