Quadra P femoral stems 01.12.144Recalls & reported problems
Medacta International SA · Quadra-P Lat. #4 · Class 2 · Implant
All models of Quadra P femoral stems (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040720564), received between Sep 1, 2021 and Dec 5, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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
- Appropriate Device Problem Term/Code Not Available1
- Loss of Osseointegration1
- Malposition of Device1
- Migration1
Patient problems
- Pain2
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2023Loss of Osseointegration; Loss of Osseointegration
THE SURGEON NOTED RADIOLUCENT LINES ON RADIOGRAPHS 9 MONTHS AFTER SURGERY AND DIAGNOSED MILD STEM LOOSENING IN ZONE 1/7/8. THE PATIENT DOES NOT COMPLAIN OF ANY PAIN OR DISCOMFORT. REVISION SURGERY IS NOT PLANNED. THE PATIENT WILL BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18266174 ↗InjuryNov 25, 2021Appropriate Device Problem Term/Code Not Available
LEFT HIP REVISION SURGERY 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION. CUP, LINER, HEAD, AND STEM REVISED.
Patient problems: Unspecified Infection
MAUDE report 12874256 ↗InjuryOct 28, 2021Malposition of Device; Malposition of Device
THE PATIENT CAME IN REPORTING PAIN DUE TO THE STEM BEING TOO ANTEVERTED AFTER THE PRIMARY HIP SURGERY. THE SURGEON IMPLANTED THE STEM ANTEVERTED IN PRIMARY. AT 3 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM, SLEEVE, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 12712182 ↗InjurySep 1, 2021Migration; Migration
2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 12405942 ↗
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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