DJO SURGICAL 803-95-275Recalls & reported problems
Encore Medical, L.P. · EXPRT Revision Hip, Trial Proximal Body Capture Bolt, 75mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190446156031), received between Sep 20, 2021 and Sep 20, 2021 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2021Loosening of Implant Not Related to Bone-Ingrowth
INSTRUMENT FAILURE - EXPERT HIP WITH SURGEON IMPLANTED DISTAL STEM. WENT TO TRIAL PROXIMAL BODY. INSERTED TRIAL PROXIMAL BODY AND CRANKED ON THE IMPLANTED TRIAL SCREW DISTAL TO MAKE SURE IT WAS TIGHT. THE TRIAL PROXIMAL BODY CAME LOOSE DURING REDUCTION AND SPUN AROUND THE IMPLANTED DISTAL STEM. ONCE PROXIMAL BODY IS LOOSE, SURGEON LOOSES HIS VERSION DURING AND CAN NOT GAUGE STABILITY OF THE CONSTRUCT.
Patient problems: Insufficient Information
MAUDE report 12500469 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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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