LUPINE ORTHOCORDRecalls & reported problems across all models

We found 4 models of LUPINE ORTHOCORD by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 112 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2018 and Sep 11, 2025 — classified as 1 injury, 111 malfunctions.

The most frequently reported specific device problem is “Break” (53 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

Most reported LUPINE ORTHOCORD problems

LUPINE ORTHOCORD models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LUPINE ORTHOCORD 210709

  STAPLE, FIXATION, BONE
  56 reports
• LUPINE ORTHOCORD 210708

  STAPLE, FIXATION, BONE
  37 reports
• LUPINE ORTHOCORD 222980

  SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
  11 reports
• LUPINE ORTHOCORD 222981

  SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
  8 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 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 23028250 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE; IT WAS DISCOVERED THAT THE ANCHOR ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 22805959 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE ANCHOR WAS BROKEN, REMOVED ALL THE BROKEN PARTS. 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 22467287 ↗
• MalfunctionJan 6, 2025Break; Break

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE LUPINE LOOPPLUS ANCHOR W/OC DS DEVICE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 21079946 ↗
• MalfunctionJan 6, 2025Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 21079944 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED FROM THE HEALTH AUTHORITY IN CHINA THAT DURING A RIGHT PATELLAR LIGAMENT PLASTY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE BROKE OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21059154 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL PARTS WERE REMOVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250941 ↗
• MalfunctionSep 4, 2024Migration; Migration

  IT WAS REPORTED FROM CHINA THAT DURING A LABRAL REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE PULLED OUT. 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 WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135714 ↗
• MalfunctionMay 24, 2024Break; Material Frayed; Break; Material Frayed

  SUTURE BREAKAGE. IT WAS REPORTED THAT DURING THE LABRAL REPAIR SURGERY, WHEN TIGHTENED THE SUTURE FOR THE LUPINE LOOP PLUS ANCHOR W/OC DEVICE, THE SUTURE WAS BROKEN OFF. 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 19391693 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023 THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476042 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN EXTERNAL ANKLE LIGAMENT PROCEDURE ON (B)(3) 2023, IT WAS OBSERVED THAT WHEN THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD WAS INSERTED, THE ANCHOR WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354949 ↗
• MalfunctionNov 30, 2023Break; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping; Break; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER AND ANKLE ARTHROSCOPY PROCEDURE ON (B)(6) 2023, THE PACKAGING OF THE LUPINE LOOP PLUS DUAL SUTURE (DS) ANCHOR W/ORTHOCORD PLA ABSORBABLE ANCHOR DEVICE WAS OPENED BUT NOT USED, AND IT WAS NOTICED TO BE DEFORMED. SEVEN REPLACEMENTS WERE ATTEMPTED TO PROCEED WITH THE SURGERY; HOWEVER, THE SAME ISSUE RECURRED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION AND WAS FRACTURED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236158 ↗
• MalfunctionNov 14, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON 10/10/2023, IT WAS OBSERVED THAT THE END OF THE SHAFT ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE WAS BROKEN AFTER INSERTION AND COULD NOT BE REMOVED; AND THEREFORE, THE ANCHOR REMAINED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18130153 ↗
• MalfunctionNov 14, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANKLE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DS DEVICE WAS BROKEN OFF THEN, ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129896 ↗
• MalfunctionOct 17, 2023Migration; Migration

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE TWO (X2) LUPINELOOPPLUS ANCHOR W/OC DS DEVICES ANCHOR BROKE AND PULLED OUT. THE ANCHOR WAS BROKEN OFF AND ALL BROKEN PARTS WERE REMOVED. ANOTHER ANCHOR WAS USED AND THAT WAS PULLED OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950808 ↗

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