Tornier HRS ARS342008Recalls & reported problems
Tornier, Inc. · Spacer · Class 2 · Implant
All models of Tornier HRS (40)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832092659), received between Jun 27, 2024 and Jun 27, 2024 — classified as 1 injury.
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
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2024Loss of Osseointegration; Loss of Osseointegration
AS REPORTED: "IT WAS REPORTED THAT A LOOSENING OF THE COMPONENTS WAS DETECTED, AND IT WAS WEARING A LOCKING CAP THAT IS SUPPOSED TO LOCK THE COMPONENTS. AFTER APPROXIMATELY 8 MONTHS OF INITIAL SURGERY, THE PATIENT NOTICED A ¿CLICK¿ AND THEY WENT TO THE EMERGENCY ROOM, WHERE THEY UNDERWENT AN X-RAY SHOWING THE DISASSEMBLY OF THE IMPLANT. HOWEVER, IT WAS NOT UNTIL (B)(6) 2024 THAT THEY WERE SEEN BY A TRAUMATOLOGIST WHO KNEW ABOUT THE IMPLANT AND WAS THE ONE WHO DETECTED THAT THE CONDITION OF THE STEM WAS NOT WHERE IT SHOULD BE. THE INITIAL SURGERY WAS ON (B)(6) 2023 AND A TORQUE SCREWDRIVER WAS USED TO ENSURE THAT THE TIGHTENING TORQUE WAS DONE WITH THE NECESSARY FORCE. THE INITIAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANYTHING TO REPORT."
Patient problems: Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture
MAUDE report 19629393 ↗
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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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