Arthrex® AR-7201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867041288), received between Mar 14, 2017 and Sep 19, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem

  THE DISTRIBUTOR REPORTED, PATIENT REACTION IN DATE CHRONOLOGY ORDER: (B)(6) 2017 - TENOPLASTY USING THE PARS SYSTEM. ON (B)(6) 2017- AFTER 1 MONTH AND 23 POSTOPERATIVE DAYS PRESENTED A REACTION PROCESS IN INCISION WITH DEHISCENCE IN THE INCISION, PATIENT DENIES TRAUMA OR EFFORT, USING ARTICULATED VACOPED BOOT. ON (B)(6) 2017- 2 MONTHS AND 14 DAYS PO- REACTION PROCESS IN THE INCISION WITH REMOVAL OF THE WHITE THREAD, IN USE OF THE BOOT TYPE ARTICULATED VACOPED. ON (B)(6) 2017- REACTION PROCESS OF THE INCISION WITH REMOVAL OF THE WHITE / BLACK WIRE, IN USE OF AN ARTICULATED VACOPED BOOT. ON (B)(6) 2017- 3 MONTHS PO- REACTION PROCESS OF THE INCISION WITH REMOVAL OF THE BLUE WIRE, WITHOUT USE OF IMMOBILIZATION. * THREE (3) MONTHS AND 10 DAYS PO- SILVERCEL CURATIVE USE. IMPROVEMENT OF APPEARANCE, WITHOUT PURULENT DISCHARGE, ONLY BLOODY. NO PAIN AND TENDON INTACT WITH GOOD FUNCTION, PATIENT DOING LOW-IMPACT DAILY ACTIVITIES. * PATIENT IS SEEN BY THE DOCTOR 3 TIMES A WEEK. IT IS PRESENTING A NEW REACTIONAL AREA, NOW OF THE DISTAL WIRES, STILL WITH REACTION PROCESS. THE DISTAL SUTURES HAVE NOT YET LEFT.

  Patient problems: Reaction; Wound Dehiscence

  MAUDE report 6875385 ↗
• InjuryMar 14, 2017Device Operates Differently Than Expected

  IT WAS REPORTED BY THE PATIENT THAT APPROX. 6 MONTHS AFTER IMPLANTATION ON (B)(6) 2012 OF THE AR-1929SF-3 ((B)(4)) AND AR-7201 ((B)(4)) INTO PATIENT´S SHOULDER, A REACTION WITH SWOLLEN JOINTS (HIP, KNEE, SHOULDER), PAIN AND GENERAL INDISPOSITION OCCURRED. NO FURTHER DETAILS GIVEN AT THIS TIME.

  Patient problems: Complaint, Ill-Defined; Joint Swelling

  MAUDE report 6401990 ↗