Arthrex® AR-1592Recalls & reported problems
Arthrex, Inc. · RETROBUTTON, XL · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867019874), received between Jun 7, 2018 and Jun 7, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
Device problems
- Patient-Device Incompatibility1
Patient problems
- Discomfort1
- Hair Loss1
- Irritation1
- Malaise1
- Scar Tissue1
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 7, 2018Patient-Device Incompatibility
IT HAS BEEN REPORTED BY A PATIENT THAT ON (B)(6) 2014 SHE HAD A RIGHT ACL RECONSTRUCTION (USING ARTHREX PRODUCT) AND MENISCAL REPAIR (USING NON-ARTHREX PRODUCTS). AN ARTHREX, AR-1592, RETROBUTTON XL WAS IMPLANTED DURING THE PROCEDURE. ALMOST IMMEDIATELY AFTER THE PROCEDURE THE PATIENT BEGAN TO SUFFER FROM MAJOR HAIR LOSS. SINCE THE SURGERY THE PATIENT HAS HAD ONGOING ISSUES WITH WHAT SHE DESCRIBES AS A PULLING/RUBBING TYPE OF SENSATION IN AND AROUND THE SURGICAL SITE. ALSO REPORTS MALAISE AND SLEEP ISSUES AS WELL AS GENERAL DISCOMFORT WITH REGARD TO THE MECHANICS OF USE OF HER KNEE. PATIENT STATES SHE HAS NO KNOWN ALLERGIES HOWEVER SHE DOES HAVE ISSUES WITH CERTAIN TYPES OF EARRING POSTS CAUSING A BLACK/GREEN COLORING/IRRITATION OF HER SKIN. PATIENT WOULD LIKE TO HAVE THE DEVICE EXPLANTED BUT HAS BEEN UNSUCCESSFUL IN LOCATING A SURGEON WILLING TO REMOVE IT. SEVERAL SURGEONS HAVE TOLD HER THAT THEY DO NOT WANT TO ATTEMPT TO REMOVE THE DEVICE DUE TO SCAR TISSUE. SHE REPORTS THAT SHE HAS BEEN WORKING FOR SOME TIME WITH A PHYSICAL THERAPIST TO WORK ON BREAKING UP ANY SCAR TISSUE THAT MIGHT BE PRESENT IN HOPES OF BEING ABLE TO FIND A SURGEON TO REMOVE THE DEVICE. PATIENT HAS REQUESTED T
Patient problems: Discomfort; Hair Loss; Irritation; Malaise; Scar Tissue; Skin Discoloration
MAUDE report 7577716 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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