LUPINE ORTHOCORD 222981Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705008599), received between Jan 29, 2019 and Apr 26, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN RUSSIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT TWO LUPINE LOOP DS W/ORTHOCORD DEVICES BROKE IN A ROW. ALL THE BROKEN FRAGMENTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213577 ↗
• MalfunctionApr 26, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT TWO LUPINE LOOP DS W/ORTHOCORD DEVICES BROKE IN A ROW. ALL THE BROKEN FRAGMENTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213570 ↗
• MalfunctionJan 26, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER JOINT INSTABILITY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LUPINE LOOP DS W/ORTHOCORD DEVICE WAS DEFORMED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 15 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231123 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER JOINT INSTABILITY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LUPINE LOOP DS W/ORTHOCORD DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 15 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231092 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER JOINT INSTABILITY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LUPINE LOOP DS W/ORTHOCORD DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 15 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231085 ↗
• InjurySep 11, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED FROM (B)(6) THAT DURING HIP SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT ONCE THE ANCHOR DEVICE HAD BEEN IMPLANTED, THE DOUBLE SUTURE WAS ALREADY TIED. ACCORDING TO THE REPORT, THE SUTURE HAD TO BE CUT AND WAS LEFT IMPLANTED. A NEW IMPLANT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH A FIVE MINUTE DELAY. THERE WERE NO FRAGMENTS WERE GENERATED. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury; Not Applicable

  MAUDE report 10521354 ↗
• MalfunctionJan 7, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY J&J EMPLOYEE VIA EMAIL, THAT DURING AN UNKNOWN PROCEDURE, THE HEALTHCARE PROFESSIONAL HAD A PROBLEM WITH A LUPINE LOOP DUAL SUTURE ANCHOR - ORTHOCORD. HE COULD NOT PLACE THEM WELL AND THEY WERE RELEASED. THE HEALIX ANCHOR WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS DISCARDED. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9559427 ↗
• MalfunctionJan 29, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING A SHOULDER PROCEDURE THE LUPINE HOOK WAS FOUND TO BE BENT. THE STATUS OF THE PATIENT AND PROCEDURE IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285957 ↗