LUPINE ORTHOCORD 222980Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705008582), received between Jul 26, 2018 and Oct 14, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

17 other recalls cover devices cleared under the same FDA submission (K040827); they may or may not involve this specific model.

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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY SALES REP VIA DISTRIBUTOR VIA COMPLAINT SUBMISSION TOOL THAT 3 LUPINE SUTURE ANCHORS WERE BROKEN (BENT) RIGHT OUT OF THE BOX. THE BOXES WERE SEALED AND IN EXCELLENT CONDITION ACCORDING TO THE NURSE. 3 OTHER LUPINE ANCHORS CAME OUT OF THE BOX WITH THE SUTURE LOOP DISENGAGED FROM THE MOUTH OF THE ANCHORS. THEY ARE ASKING FOR A CREDIT FOR THESE 6 ANCHORS AND A FOLLOW UP REPORT ON WHY THIS OCCURRED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS A SURGERY DELAY OF 5 MINUTES REPORTED. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION

  Patient problems: Not Applicable

  MAUDE report 10681094 ↗
• MalfunctionOct 14, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY SALES REP VIA DISTRIBUTOR VIA COMPLAINT SUBMISSION TOOL THAT 3 LUPINE SUTURE ANCHORS WERE BROKEN (BENT) RIGHT OUT OF THE BOX. THE BOXES WERE SEALED AND IN EXCELLENT CONDITION ACCORDING TO THE NURSE. 3 OTHER LUPINE ANCHORS CAME OUT OF THE BOX WITH THE SUTURE LOOP DISENGAGED FROM THE MOUTH OF THE ANCHORS. THEY ARE ASKING FOR A CREDIT FOR THESE 6 ANCHORS AND A FOLLOW UP REPORT ON WHY THIS OCCURRED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS A SURGERY DELAY OF 5 MINUTES REPORTED. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10681077 ↗
• MalfunctionOct 14, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY SALES REP VIA DISTRIBUTOR VIA COMPLAINT SUBMISSION TOOL THAT 3 LUPINE SUTURE ANCHORS WERE BROKEN (BENT) RIGHT OUT OF THE BOX. THE BOXES WERE SEALED AND IN EXCELLENT CONDITION ACCORDING TO THE NURSE. 3 OTHER LUPINE ANCHORS CAME OUT OF THE BOX WITH THE SUTURE LOOP DISENGAGED FROM THE MOUTH OF THE ANCHORS. THEY ARE ASKING FOR A CREDIT FOR THESE 6 ANCHORS AND A FOLLOW UP REPORT ON WHY THIS OCCURRED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS A SURGERY DELAY OF 5 MINUTES REPORTED. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION

  Patient problems: Not Applicable

  MAUDE report 10681060 ↗
• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING BANKART REPAIR, IT WAS OBSERVED THAT THREE ANCHOR DEVICES WERE BENT RIGHT OUT OF THE BOX. ACCORDING TO THE REPORT, THE BOXES WERE SEALED AND IN EXCELLENT CONDITION. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE FACILITY, IT WAS DETERMINED THAT THE DEVICE WAS BENT. THERE WAS A FIVE MINUTE DELAY IN THE SURGERY TO GET OPEN A NEW IMPLANT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10521260 ↗
• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING BANKART REPAIR, IT WAS OBSERVED THAT THREE ANCHOR DEVICES WERE BENT RIGHT OUT OF THE BOX. ACCORDING TO THE REPORT, THE BOXES WERE SEALED AND IN EXCELLENT CONDITION. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE FACILITY, IT WAS DETERMINED THAT THE DEVICE WAS BENT. THERE WAS A FIVE MINUTE DELAY IN THE SURGERY TO GET OPEN A NEW IMPLANT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10521253 ↗
• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING BANKART REPAIR, IT WAS OBSERVED THAT THREE ANCHOR DEVICES WERE BENT RIGHT OUT OF THE BOX. ACCORDING TO THE REPORT, THE BOXES WERE SEALED AND IN EXCELLENT CONDITION. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE FACILITY, IT WAS DETERMINED THAT THE DEVICE WAS BENT. THERE WAS A FIVE MINUTE DELAY IN THE SURGERY TO GET OPEN A NEW IMPLANT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10521239 ↗
• MalfunctionApr 13, 2020Migration; Migration

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT PRE-OPERATIVELY TO AN UNKNOWN PROCEDURE IT WAS FOUND THAT A LUPINE LOOP ANCHOR- ORTHOCORD CAME WITH THE WIRED REMOVED FROM ANCHOR. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9955209 ↗
• MalfunctionSep 26, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING THE SURGICAL PROCEDURE OF SHOULDER ARTHROSCOPY, AT THE TIME OF OPENING THE ANCHOR LUPINE IMPLANT BOX, THE PHYSICIAN IDENTIFIED THAT THE LOOP OF THE ORTHOCORD THREAD THAT IS IN THE ANCHOR LUPINE WAS LOOSE. ANOTHER LUPINE ANCHOR WAS ASKED BY THE DOCTOR AND DURING OPENING THE SECOND IMPLANT BOX, THE DOCTOR IDENTIFIED THAT THE ORTHOCORD THREAD THAT IS IN THE ANCHOR LUPINE IS ALSO LOOSE, SAYING THAT MATERIAL (ANCHOR LUPINE) COULD HAVE HAD SOME PROBLEM AT THE MANUFACTURING LINE. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9123034 ↗
• MalfunctionSep 13, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING THE SURGICAL PROCEDURE OF SHOULDER ARTHROSCOPY, AT THE TIME OF OPENING THE ANCHOR LUPINE IMPLANT BOX, THE PHYSICIAN IDENTIFIED THAT THE LOOP OF THE ORTHOCORD THREAD THAT WAS IN THE ANCHOR LUPINE WAS LOOSE. ANOTHER LUPINE ANCHOR WAS ASKED BY THE DOCTOR AND DURING OPENING THE SECOND IMPLANT BOX, THE DOCTOR IDENTIFIED THAT THE ORTHOCORD THREAD THAT WAS IN THE ANCHOR LUPINE WAS ALSO LOOSE, SAYING THAT MATERIAL (ANCHOR LUPINE) COULD HAVE HAD SOME PROBLEM AT THE MANUFACTURING LINE. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9031296 ↗
• MalfunctionAug 2, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF LUPINE ANCHOR BROKE IN THE PATIENT AT THE TIME OF INTRODUCTION. IT WAS REPORTED THAT IT WAS REPLACED BY ANOTHER ANCHOR LUPINE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7742610 ↗
• MalfunctionJul 26, 2018Break; Break

  EVENT: IT WAS REPORTED DURING THE PROCEDURE OF DR. PATIENT (B)(6), AT THE HOSPITAL (B)(6), THE LUPINE ANCHOR (CODE: 222980 AND LOT 3874316) BROKE THE WIRE AND HE COULD NOT BE USED IT. PRODUCT INFORMATION: 222980 AND LOT 3874316, FOUR PRODUCTS WERE OPENED, ONE BEING QUOTED ABOVE. NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7722016 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040827. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1167-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop Plus Anchor w/Ethibond Catalog Number: 210710 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1170-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1164-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1171-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1169-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1163-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1166-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS Catalog Number: 210709 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1162-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1168-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1165-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated for use in soft tissue bone fixation.

…and 2 more.