LUPINE ORTHOCORDRecalls & reported problems across all models
Medos International Sàrl · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 409
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls
- 0
We found 2 models of LUPINE ORTHOCORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 409 adverse event reports in the FDA's MAUDE database, received between May 9, 2018 and Sep 18, 2026 — classified as 36 injuries, 373 malfunctions.
The most frequently reported specific device problem is “Break” (174 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LUPINE ORTHOCORD problems
Device problems
- Break174
- Material Deformation79
- Device Damaged Prior to Use43
- Material Twisted/Bent37
- Migration37
- Detachment of Device or Device Component31
- Migration or Expulsion of Device19
- Deformation Due to Compressive Stress17
Patient problems
- No Clinical Signs, Symptoms or Conditions269
- No Consequences Or Impact To Patient88
- Not Applicable39
- Injury18
- No Code Available12
- Unspecified Tissue Injury9
- Foreign Body In Patient5
- Unspecified Infection3
LUPINE ORTHOCORD models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LUPINE ORTHOCORD 210712SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- LUPINE ORTHOCORD 210711Suture, nonabsorbable, synthetic, polyester52 reports
Recent LUPINE ORTHOCORD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823355 ↗MalfunctionSep 18, 2026Use of Device Problem; Detachment of Device or Device Component
It was reported that during biceps tenodesis surgery, the LUPINE ORTHOCORD device sutures came detached from the loop part of the anchor body, thus resulting in failure. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818355 ↗MalfunctionSep 14, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758121 ↗MalfunctionSep 1, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542585 ↗MalfunctionAug 19, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50330929 ↗MalfunctionJun 17, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE LUPINE BR DS W/ORTHCRD ANCHOR DEVICE TIP OF THE ANCHOR BROKE OFF. REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537202 ↗MalfunctionMay 29, 2026Migration
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY, THE LUPINE ORTHOCORD DEVICE ANCHOR PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330945 ↗MalfunctionMay 1, 2026Material Fragmentation; Device Damaged Prior to Receipt by User; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LUPINE ORTHOCORD DEVICE WAS FRACTURED AND FELL APART. IT WAS NOTED IN THE SERVICE ORDER THAT THE DURING THE SURGERY, THE DEVICE DETACHED FROM THE ANCHOR AND THE ANCHOR WAS DEFORMED INSIDE THE PACKAGE. IT WAS NOTED THAT THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058656 ↗MalfunctionMay 1, 2026Device Damaged Prior to Receipt by User; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LUPINE ORTHOCORD DEVICE FELL APART. IT WAS NOTED IN THE SERVICE ORDER THAT THE DURING THE SURGERY, THE DEVICE DETACHED FROM THE ANCHOR AND THE ANCHOR WAS DEFORMED INSIDE THE PACKAGE. IT WAS NOTED THAT THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058654 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY RECONSTRUCTION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LUPINE ORTHOCORD DEVICE ANCHOR BROKE OFF. ALL BROKE PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956930 ↗MalfunctionApr 21, 2026Product Quality Problem; Material Deformation
IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE LUPINE BR DS W/ORTHCRD DEVICE WAS DEFORMED/BENT. IT WAS INITIALLY REPORTED THAT BEFORE A PATELLAR DISLOCATION SURGERY, THE PACKAGING HAD BEEN OPENED AND NOT USED. THE ANCHOR WAS MISSING. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939967 ↗MalfunctionMar 13, 2026Migration
IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE LUPINE BR DS W/ORTHCRD ANCHOR DEVICE PULLED OUT OF THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 10 MIN DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590744 ↗MalfunctionMar 11, 2026Migration
IT WAS REPORTED THAT DURING A REPAIR OF ANTERIOR TALOFIBULAR LIGAMENT SURGERY, THE LUPINE BR DS W/ORTHCRD ANCHOR WAS PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A FIVE MINUTE DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24575811 ↗MalfunctionMar 11, 2026Break
IT WAS REPORTED THAT DURING A SOFT TISSUE REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LUPINE BR DS W/ORTHCRD DEVICE ANCHOR BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571492 ↗MalfunctionFeb 23, 2026Break
IT WAS REPORTED THAT DURING LABRAL REPAIR SURGERY, THE LUPINE BR DS W/ORTHCRD ANCHOR DEVICE WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24421157 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 reports
- FMS39 models · 3,588 reports
- EXPEDIUM291 models · 3,312 reports
- EXPEDIUM VERSE90 models · 2,686 reports
- EXPRESSEW6 models · 2,459 reports
- OMNISPAN ORTHOCORD3 models · 1,581 reports
- HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
- PROWLER SELECT9 models · 1,066 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page