Arthrex® AR-5511-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867109698), received between Sep 18, 2017 and Apr 25, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT CALLED IN AN INQUIRY ABOUT THE MATERIAL COMPOSITION FOR THE AR-1588AL-CP2 IMPLANT SYSTEM, AR-1588TNT2 FIBERTAG TIGHTROPE II ABS, AR-1588RTT2-IB FIBERTAG® TIGHTROPE® II IMPLANT, AR-5511-CP IMPLANT SYSTEM, AND AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHOR. THERE WAS NO ALLEGATION OF PRODUCT DEFICIENCY OR ADVERSE EVENTS REPORTED WITHIN THIS INQUIRY. ON 04/11/2025, IT WAS REPORTED BY THE PATIENT VIA PHONE THAT SHE UNDERWENT AN ACL RECONSTRUCTION ON (B)(6) 2024 WHERE THE AR-1588AL-CP2 IMPLANT SYSTEM, AR-1588TNT2 FIBERTAG TIGHTROPE II ABS, AR-1588RTT2-IB FIBERTAG® TIGHTROPE® II IMPLANT, AR-5511-CP IMPLANT SYSTEM, AND AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHOR WERE IMPLANTED. THE PATIENT BEGAN TO EXPERIENCE AN ALLERGIC REACTION IN (B)(6) 2024 THE ALLERGIC REACTION WAS CONFIRMED BY A PHYSICIAN. THE PATIENT HAD A VISIBLE RASH, BLISTERS, AND OOZING OUT THE INCISIONS. HER LEG, KNEE, AND ANKLE WERE SWOLLEN WITH FLUID. IT WOULD GO AND COME, THIS HAPPENED UNTIL THE PROCEDURE IN (B)(6) 2024 WHERE THEY WENT IN AND CLEANED SCAR TISSUE. AFTER THIS PROCEDURE, THE REACTION WORSENED IT SPREAD TO THE WHOLE RIGHT LEG. THIS HAS BEEN AN ON AND OFF ISSUE SINCE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21910984 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT AN LCL RECONSTRUCTION PROCEDURE USING AN AR-5511-CP INTERNAL BRACE KNEE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM. POST-OPERATIVE, PATIENT DEVELOPED AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16050820 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT AN MCL PROCEDURE USING AN AR-5511-CP INTERNAL BRACE KNEE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM. POST-OPERATIVE, PATIENT DEVELOPED AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16050797 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT AN MCL PROCEDURE USING AN AR-5511-CP INTERNAL BRACE KNEE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM. POST-OPERATIVE, PATIENT DEVELOPED AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16050773 ↗
• InjuryOct 5, 2020Break

  IT WAS REPORTED THAT DURING A (B)(6) 2020 QUAD TENDON REPAIR PROCEDURE TWO OF THE 4.75 BIO-COMPOSITE SWIVELOCKS BROKE FROM THE AR-5511-CP (INTERNAL BRACE KNEE LIGAMENT AUGMENT REPAIR IMPLANT SYSTEM), LOT 11087908. THE ANCHORS WERE BEING USED FOR ANCHORING TWO LIMBS EACH OF 2MM FIBERTAPE KRAKOW STITCHES THROUGH THE QUAD TENDON AND INTO THE PATELLA. THE 2.4 MM GUIDE PINS WERE PLACED IN THE SUPERIOR ASPECT OF THE PATELLA, ADVANCED 20MM IN. THEY WERE PLACED ROUGHLY 10MM APART FROM ONE ANOTHER. THE PINS WERE CHECKED WITH C-ARM TO CONFIRM THEY WERE CONTAINED WITHIN THE PATELLA. ONCE CONFIRMED ON AP AND LATERAL SHOTS THE PINS WERE OVER-DRILLED WITH THE 4.5MM DRILL FROM THE KIT TO A DEPTH OF 20MM. ONCE FULLY DRILLED THE TUNNELS WERE TAPPED WITH THE GREEN TAP FROM THE KIT ALL THE WAY TO THE LASER LINE. THE LATERAL ANCHOR WAS PLACED FIRST. TENSION ON THE TAPE APPLIED AND EYELET BROUGHT APERTURE WITH TWO TAPED LOADED IN THE ANCHOR. THE ANCHOR WAS LIGHTLY TAPPED WITH A MALLET UNTIL THE WHITE ANCHOR BODY ABUTTED THE BONE. THEN PER TECHNIQUE THE ANCHOR WAS ADVANCED. THE ANCHOR ADVANCED ROUGHLY HALF OF THE WAY IN AND THEN BROKE. THERE APPEARED TO BE 8MM OR SO OF THE ANCHOR BODY IN THE BONE. THE F

  Patient problems: Insufficient Information

  MAUDE report 10630981 ↗
• InjuryJul 31, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN MCL REPAIR IN HER LEFT KNEE ON (B)(6) 2017 WHERE TWO ARTHREX DOUBLE LOADED 3.0 BIOCOMPOSITE SUTURETAKS AND AN MCL INTERNAL BRACE WITH TWO 4.75 BIOCOMPOSITE SWIVELOCKS AND A FIBERTAPE WERE IMPLANTED. HIVES AND ITCHING ALL OVER BODY AND ACCOMPANYING DERMATOGRAPHIA BEGAN HAPPENING THE DAY OF SURGERY UPON RETURN HOME FROM THE PROCEDURE. THIS HAS BEEN CONSTANT SINCE THEN WITH RELIEF ONLY PROVIDED BY ALLEGRA. ALLERGY SCRATCH TEST, COMPREHENSIVE BLOOD-WORK, CHEST X-RAYS, AND CONTACT DERMATITIS PATCH TEST HAVE ALL BEEN DONE AND RETURNED INCONCLUSIVE FOR CAUSE OF REACTION. AFTER NUMEROUS ALLERGEN AND CONTACT DERMATITIS TESTS, MOST COMMON ALLERGENS HAVE BEEN RULED OUT AND A FEW CLINICIANS THE PATIENT HAS SEEN, SUSPECT THAT THE REACTION MAY BE DUE TO THE PARTS USED IN HER SURGERY LAST YEAR.

  Patient problems: Itching Sensation; Reaction

  MAUDE report 7734403 ↗
• InjurySep 18, 2017Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY A REGIONAL MANAGER, THAT A PATIENT IS HAVING COMPLICATIONS FROM A SWIVELOCK IMPLANT. NO FURTHER DETAILS WERE PROVIDED. REP WILL CALL IN WITH THE REST OF INFORMATION. ADDITIONAL INFORMATION RECEIVED 8/30/2017: IT WAS REPORTED TO THE SALES REPRESENTATIVE FROM THE PATIENT THAT SHE IS EXPERIENCING A LOT OF SOFT TISSUE IRRITATION, SORENESS AND SWELLING. THE IRRITATION IS AROUND THE TIBIAL INSERTION. THE PATIENT STATES THAT SHE WAS HEALING FINE UNTIL SHE WALKED EXTENSIVELY IN HIGH HEELS. A MRI HAS BEEN PERFORMED AND CONFIRMED THAT THE IMPLANT IS STILL IN THE BONE. SHE HAS CONTINUED PHYSICAL THERAPY AND HAS BURSITIS FORMATION. ADDITIONAL INFORMATION OBTAINED FROM PATIENT: SURGERY TOOK PLACE (B)(6) 2016, NOT (B)(6) 2017 AS ORIGINALLY REPORTED BY SALES REP. SURGERY WAS A GRADE 3 MCL RUPTURE REPAIR. AT TIME OF PATIENT ADDITIONAL INFORMATION PATIENT STATED IT HAD BEEN SEVEN MONTHS SINCE THE EVENT THAT LED TO WHAT SHE FEELS MAY BE A POSSIBLE INTERNAL BRACE FAILURE. TIME IS NOT HEALING THE NEW PAIN AND INFLAMMATION. WALKING IS LIMITED, FULL EXTENSION IS LIMITED TO BRIEF PERIODS ONLY AND PAIN WITH TRANSITIONS FROM SITTING TO STANDING IS REPORTED TO BE DEBILITATING. THE INSIDE

  Patient problems: Inflammation; Irritation; Swelling

  MAUDE report 6873250 ↗