Arthrex® AR-7298Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867197435), received between Dec 13, 2018 and Aug 25, 2023 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2023, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED TO A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023 FOR DEVICE EXPLANATION DUE TO THE LOOSENING OF THE IMPLANTS IN THE GLENOID. THE REVISION SURGERY WAS COMPLETED BY IMPLANTING A CEMENT SPACER INTO THE JOINT SPACE. THE ORIGINAL PROCEDURE WHERE THE UNIVERS APEX SYSTEM WAS IMPLANTED WAS PERFORMED ON (B)(6) 2017.

  Patient problems: Failure of Implant

  MAUDE report 17626102 ↗
• InjuryJan 27, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW5091542) THAT THE FOLLOWING INCIDENT OCCURRED: PATIENT WAS HAVING TOTAL SHOULDER PROCEDURE. A DRILL BIT WAS USED. THE TIP BROKE OFF AND WAS NOT NOTICED. POST OP VISIT SHOULDER WAS TENDER AND SWOLLEN. X-RAY FILM SHOWED APPROXIMATELY 1.5 CM DRILL TIP IN SHOULDER. CT SHOWED ABSCESS. THE FDA MEDWATCH LETTER DID NOT CONTAIN ANY FACILITY OR REPORTER NAME OR CONTACT INFORMATION. NO FOLLOW UP IS POSSIBLE AT THIS TIME.

  Patient problems: Abscess; Swelling

  MAUDE report 9631316 ↗
• InjuryDec 13, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT REQUIRED A REVISION FROM AN APEX TOTAL SHOULDER THAT HE HAD IN (B)(6) 2017. THE REVISION WAS NEEDED DUE TO A TORN SUBSCAPULAR. THE ORIGINAL DEVICES WERE REMOVED AND REPLACED WITH AR-9560-24-2 AND AR-9561-30S. UPDATED 11/29/2018: PARTS/LOT PROVIDED BY THE SALES REP. ORIGINAL PROCEDURE SURGEON WAS DIFFERENT THAN THE REVISION SURGEON. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY. EXPLANTED DEVICES WERE AS FOLLOWS: AR-9100-06S, UNIVERS APEX HUMERAL STEM, LOT 10064881; AR-9106-02 , UNIVERS VAULTLOCK GLENOID , LOT 1027261621; AR-7298 , UNIVERS SPEX SUTURE KIT, LOT 10129987; AR-9150-19P, USP II HUMERAL HEAD , LOT 160084018.

  Patient problems: Excessive Tear Production

  MAUDE report 8160817 ↗