Skip to content

LUPINE ORTHOCORD 210708Recalls & reported problems

Depuy Mitek, LLC · LUPINE Loop Plus Anchor w/ORTHOCORD Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braided Composite Suture, 36 Inches (91cm). Size 2 (5 metric) ORTHOCORD eyelet loop. · Class 2 · Implant

All models of LUPINE ORTHOCORD (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This DePuy Mitek Lupine Loop Plus Anchor with Orthocord suture is a soft-tissue anchor used to tie tendon and ligament repairs to bone during shoulder, knee and ankle procedures. The 37 adverse event reports mostly describe the anchor or the suture breaking, bending, or twisting — often when the package was opened or the suture was tightened — and arriving already damaged. None of the reports describe a death or an injury, and in most cases the surgery was finished with another device. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
37
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886705001064), received between Jun 18, 2018 and May 24, 2024 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

7 other recalls cover devices cleared under the same FDA submission (K062170, K150209); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break14
  • Material Deformation10
  • Material Twisted/Bent10
  • Device Damaged Prior to Use8
  • Bent2
  • Deformation Due to Compressive Stress2
  • Detachment of Device or Device Component1
  • Material Frayed1

Patient problems

  • No Consequences Or Impact To Patient24
  • No Clinical Signs, Symptoms or Conditions12
  • Not Applicable2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

  • 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 ↗
  • 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 ↗
  • MalfunctionJan 25, 2023Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A INSTABILITY OF SHOULDER JOINT PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DEVICE WAS DEFORMED UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION OF THE COMPLAINT SAMPLE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE DEVICE WAS BENT. 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 16240953 ↗
  • MalfunctionDec 22, 2022Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT BEFORE AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DEVICE WAS DEFORMED AND THEN IT BROKE WITH A TOUCH. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR WAS BROKEN AND HAD NO SIGNS OF BENDING. 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 16035813 ↗
  • MalfunctionOct 18, 2022Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE ANCHOR WAS BROKEN. CHANGED ANOTHER TWO 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 NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15627617 ↗
  • MalfunctionOct 18, 2022Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

    THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE ANCHOR WAS BROKEN. CHANGED ANOTHER TWO 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 NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15627546 ↗
  • MalfunctionOct 18, 2022Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE ANCHOR WAS BENT. CHANGED ANOTHER TWO 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 NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15627436 ↗
  • MalfunctionSep 6, 2022Break; Break

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15365120 ↗
  • MalfunctionDec 2, 2021Material Deformation; Material Deformation

    IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE LUPINE LOOP PLUS ANCHOR W/OC DEVICE WAS DEFORMED WHEN OPENING ITS PACKAGE. 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 12919441 ↗
  • MalfunctionSep 27, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT ANCHOR WAS BROKEN UPON OPENING THE PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR WAS BENT AND THE DEVICE HAD RESIDUES OF BIOLOGICAL MATTER. 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 12532696 ↗
  • MalfunctionJan 14, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

    IT WAS REPORTED BY THE AFFILIATE IN CHINA THAT DURING A LIGAMENT REPAIR PROCEDURE ON (B)(6) 2020 FOR THE RIGHT KNEE MEDIAL COLLATERAL LIGAMENT INJURY, IT WAS OBSERVED THAT THE BODY OF THE LUPINE LOOP PLUS ANCHOR W/OC DEVICE WAS DEFORMED UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BENT IN THE MIDDLE SECTION. 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 11171601 ↗
  • MalfunctionDec 22, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A LIGAMENT REPAIR PROCEDURE ON (B)(6) 2020 FOR THE RIGHT KNEE MEDIAL COLLATERAL LIGAMENT INJURY, IT WAS OBSERVED THAT THE BODY OF THE LUPINE LOOP PLUS ANCHOR W/OC DEVICE WAS DEFORMED UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BENT IN THE MIDDLE SECTION. 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 11055889 ↗
  • MalfunctionNov 2, 2020Break; Break

    IT WAS REPORTED THAT DURING THE SURGERY OF MENISCUS REPAIR, THE ANCHOR WAS BROKEN OFF INTO SOME PIECES, REMOVED ALL THE PIECES. CHANGED ANOTHER ONE, THE EVENT RE-HAPPENED. 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 Consequences Or Impact To Patient

    MAUDE report 10775071 ↗
  • MalfunctionNov 2, 2020Break; Break

    IT WAS REPORTED THAT DURING THE SURGERY OF MENISCUS REPAIR ,THE ANCHOR WAS BROKEN OFF INTO SOME PIECES, REMOVED ALL THE PIECES. CHANGED ANOTHER ONE, THE EVENT RE-HAPPENED. 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 Consequences Or Impact To Patient

    MAUDE report 10774758 ↗
  • MalfunctionOct 8, 2020Break; Break

    IT WAS REPORTED THAT THE PATIENT INDICATION IS LEFT KNEE MEDIAL COLLATERAL LIGAMENT INJURY. DURING THE SURGERY OF LIGAMENT REPAIR, WHEN IMPLANTING THE ANCHOR, THE BODY OF ANCHOR WAS BROKEN OFF. ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 Consequences Or Impact To Patient

    MAUDE report 10653056 ↗
  • MalfunctionJun 19, 2020Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED BY AFFILIATE VIA DISTRIBUTOR VIA PHONE THAT DURING THE ROTATOR CUFF REPAIR SURGERY, OPENED THE PACKING(DID NOT USE ON THE PATIENT), NOTED THE ANCHOR( LUPINE LOOP PLUS ANCHOR W/OC) WAS DEFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10174511 ↗
  • MalfunctionNov 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DID NOT HAVE THE SUTURE IN THE ANCHOR; AND THAT THE SUTURE WAS SITTING AT THE TOP OF IT. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF 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 9356144 ↗
  • MalfunctionSep 16, 2019Material Deformation; Material Deformation

    THE SALES REP REPORTED VIA PHONE THAT TWO OF THE CUSTOMER'S LUPINE LOOP PLUS WITH ORTHOCORD WERE BENT AT THE DISTILL TIP PRIOR TO A SHOULDER PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICES ARE BEING RETURNED. THIS IS REPORT 2 FOR 2 (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9069660 ↗
  • MalfunctionSep 12, 2019Material Twisted/Bent; Material Twisted/Bent

    THE SALES REP REPORTED VIA PHONE THAT TWO OF THE CUSTOMER'S LUPINE LOOP PLUS WITH ORTHOCORD WERE BENT AT THE DISTILL TIP PRIOR TO A SHOULDER PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICES ARE BEING RETURNED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9013312 ↗
  • MalfunctionSep 12, 2019Break; Break

    IT WAS REPORTED BY THE SALES REP THAT THREE OF HIS LUPINE LOOP PLUS WITH ORTHOCORD WERE BROKE INSIDE THE PACKAGE AND BEING HELD TOGETHER BY THE SUTURE PRIOR TO A LABRAL REPAIR. ONLY ONE OF THE THREE ANCHORS, THE SUTURE IS OFF FROM THE ANCHOR, DUE TO EXTREME DEFORMITY. THE CASE WAS COMPLETED WITH TWO OTHER LIKE DEVICES. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICES ARE BEING RETURNED. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9005905 ↗
  • MalfunctionSep 12, 2019Break; Break

    IT WAS REPORTED BY THE SALES REP THAT THREE OF HIS LUPINE LOOP PLUS WITH ORTHOCORD WERE BROKE INSIDE THE PACKAGE AND BEING HELD TOGETHER BY THE SUTURE PRIOR TO A LABRAL REPAIR. ONLY ONE OF THE THREE ANCHORS, THE SUTURE IS OFF FROM THE ANCHOR, DUE TO EXTREME DEFORMITY. THE CASE WAS COMPLETED WITH TWO OTHER LIKE DEVICES. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICES ARE BEING RETURNED. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9005891 ↗
  • MalfunctionSep 11, 2019Break; Break

    IT WAS REPORTED BY THE SALES REP THAT THREE OF HIS LUPINE LOOP PLUS WITH ORTHOCORD WERE BROKE INSIDE THE PACKAGE AND BEING HELD TOGETHER BY THE SUTURE PRIOR TO A LABRAL REPAIR. THE SUTURE IS OFF FROM THE ANCHOR, DUE TO EXTREME DEFORMITY. THE CASE WAS COMPLETED WITH TWO OTHER LIKE DEVICES. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICES ARE BEING RETURNED. THIS IS REPORT 1 FOR 1 (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8996824 ↗
  • MalfunctionJun 3, 2019Material Twisted/Bent; Material Twisted/Bent

    ADDITIONAL INFORMATION WAS RECEIVED BY THE AFFILIATE REPORTING THAT EXCESSIVE FORCE WAS NOT USED WHILE WORKING WITH THE IMPLANT. THE BEND OF THE IMPLANT WAS VISIBLE TO THE OPERATING STAFF WHEN THE DEVICE WAS REMOVED FROM IT'S PACKAGING. THE DEFORMITY WAS OBSERVED INTRA-OP AND RESULTED IN A 30 MINUTE SURGICAL DELAY. THE PROCEDURE WAS ABLE TO BE COMPLETED AND THERE IS NO KNOWN PATIENT CONSEQUENCES.

    Patient problems: No Consequences Or Impact To Patient; Not Applicable

    MAUDE report 8663354 ↗
  • MalfunctionJun 3, 2019Material Twisted/Bent; Material Twisted/Bent

    ADDITIONAL INFORMATION WAS RECEIVED BY THE AFFILIATE REPORTING THAT EXCESSIVE FORCE WAS NOT USED WHILE WORKING WITH THE IMPLANT. THE BEND OF THE IMPLANT WAS VISIBLE TO THE OPERATING STAFF WHEN THE DEVICE WAS REMOVED FROM IT'S PACKAGING. THE DEFORMITY WAS OBSERVED INTRA-OP AND RESULTED IN A 30 MINUTE SURGICAL DELAY. THE PROCEDURE WAS ABLE TO BE COMPLETED AND THERE IS NO KNOWN PATIENT CONSEQUENCES.

    Patient problems: No Consequences Or Impact To Patient; Not Applicable

    MAUDE report 8663351 ↗
  • MalfunctionJan 28, 2019Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE LUPINE LOOP PLUS ANCHOR W/OC DEVICE WAS DEFECTIVE. ACCORDING TO THE REPORTER, AFTER DRILLING, THE DEVICE WAS OPENED AND BEFORE INSERTION INTO THE GUIDE IT WAS WHEN THE ISSUE WAS OBSERVED. THE SURGERY DID NOT GET HAMPERED AS EXTRA IMPLANTS WERE AVAILABLE AND A NEW IMPLANT WAS OPENED AND USED. THERE WAS A DELAY OF ABOUT ONE MINUTE IN THE SURGERY. THE SURGEON HAS NOT RAISED ANY CONCERN OR COMPLAINT. 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 8281335 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062170, K150209. One submission often covers many models, so check the product and lot details in each record.

  • 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-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-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-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-0315-2012 · Oct 31, 2011 · Terminated
    DePuy Mitek Lupine Loop Plus w/ Orthocord Catalog #210708 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate posto
  • Z-0316-2012 · Oct 31, 2011 · Terminated
    DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate pos

Other STAPLE, FIXATION, BONE devices

All STAPLE, FIXATION, BONE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page