Quadra H femoral stems 01.12.98SNRecalls & reported problems
Medacta International SA · QUADRA "H" Short neck, cem.less, std, S.00 · 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
- 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 07630030802935), received between Sep 15, 2020 and Jul 6, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
- Osseointegration Problem1
Patient problems
- Aseptic loosening1
- Implant Pain1
- Inadequate Osseointegration1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 6, 2026Osseointegration Problem
PRIMARY HIP SURGERY WAS PERFORMED ON (B)(6) 2022. APPROXIMATELY ONE YEAR BEFORE THE REVISION SURGERY, THE PATIENT REPORTED THE ONSET OF MID-THIGH PAIN AND INITIALLY CONSULTED THEIR LOCAL DOCTOR, RECEIVING PAIN MANAGEMENT AND PHYSIOTHERAPY BEFORE BEING REVIEWED BY AN ORTHOPAEDIC CONSULTANT. DURING THE CLINICAL INVESTIGATION, THE REVISION SURGEON NOTED PROXIMAL LOOSENING ON X-RAY, REFERRING TO THE FEMORAL STEM. BASED ON THESE FINDINGS, THE SURGEON DECIDED TO REMOVE THE STEM AND CHANGE THE CUP SIZE, AS THE PATIENT WAS CONSIDERED TO BE AT INCREASED RISK OF DISLOCATION DUE TO OBESITY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DURING WHICH ALL IMPLANTS WERE REPLACED WITH COMPETITOR DEVICES ACCORDING TO THE SURGEON`S PREFERENCE, WITH IMPLANTATION OF A SIZE 50 COMPETITOR DUAL MOBILITY CUP.
Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration
MAUDE report 25714731 ↗InjurySep 15, 2020Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM; THE CAUSE OF THE LOOSE STEM IS UNKNOWN. 3 YEARS 9 MONTHS AFTER PRIMARY SURGERY THE SURGEON REVISED THE STEM AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 10535330 ↗
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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