Arthrex® AR-7209TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867041394), received between May 23, 2019 and Jun 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2019 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-1588RT-J, LOT: 10259067; AR-1897S, LOT: 10224925; AR-4030C-10, LOT: 10198681; AR-7209T, LOT: 12863; JRF SPEEDGRAFT ID: 183528-015 (NOT AN ARTHREX PRODUCT). THIS CASE WAS COMPLETED WITH NO ISSUE. THE PATIENT WAS SEEN FOR HIS FIRST POST-OP VISIT ON (B)(6) 2019 AND PER THE PA: ¿SKIN INTACT; PORT AND GRAFT INCISIONS CLEAN, DRY AND INTACT WITH SUTURES. NO ERYTHEMA OR SIGNS OF INFECTION. MILD REDNESS SECONDARY TO SUTURE REACTION.¿ THE PATIENT WAS SEEN FOR A 2ND FOLLOW-UP VISIT AND THE SURGEON REPORTED: ¿35ML OF SEROSANGUINOUS FLUID ASPIRATED FROM THE RIGHT KNEE AFTER ALCOHOL PREP, NO HINT OF TURBIDITY.¿ THIS WAS DONE IN RESPONSE TO INCREASED DWELLING AND DISABILITY FOR THREE DAYS. SURGEON REPORTS: ¿NOT CLINICALLY A DVT; INFECTION A CONCERN, BUT ALSO, CLINICALLY, DOES NOT LOOK LIKE IT.¿ PATIENT WAS PLACED ON BACTRIMDS BY MOUTH TWICE DAILY FOR SEVEN DAYS. THE FLUID WAS SENT FOR CELL COUNT. PER THE REPORT, THE FLUID WAS CLOUDY WITH TOTAL NUCLEATED CELL COUNT AT 6800 AND NEUTROPHILS AT 75. THE PATIENT WAS SEEN FOR HIS THIRD POST-OP FOLLOW UP VISIT ON (B)(6)

  Patient problems: Erythema; Fluid Discharge; Inflammation; Irritation; Loss of Range of Motion; Reaction; Unspecified Infection

  MAUDE report 8734922 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT EXPERIENCED AN INFECTION AFTER HAVING ARTHREX PARTS IMPLANTED. AT THE TIME OF THE CALL THE FACILITY REPORTER WAS LOOKING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE IMPLANTS, AND DID NOT HAVE ANY OTHER AVAILABLE INFORMATION OTHER THAN THE ARTHREX PARTS THAT WERE USED IN THE ORIGINAL PROCEDURE. THE FOLLOWING ARTHREX PARTS WERE USED DURING THE ORIGINAL PROCEDURE: AR-2271 // LOT: F185810, AR-7209T, AND AR-2275. UPDATE (B)(6) 2019: SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITH NO RESPONSE RECEIVED. ADDITIONAL INFORMATION OBTAINED (B)(6) 2019: THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2019. THE PROCEDURE WAS A RIGHT SHOULDER OPEN ARTHROTOMY ACROMIOCLAVICULAR JOINT, ACROMIOCLAVICULAR DISLOCATION REPAIR AND JOINT INJECTION. THE PATIENT BEGAN EXPERIENCING SYMPTOMS SIX WEEKS POST-OP. THE PATIENT UNDERWENT A SURGICAL WOUND WASHOUT (DATE UNKNOWN) AND WAS TREATED WITH IV ANTIBIOTICS AND PROGRESSED TO ORAL ANTIBIOTICS. SINUS TRACK DRAINAGE WAS DONE AND A PICO DRESSING WAS PLACED. ONE WEEK LATER THE WOUND WAS SUTURED CLOSED AND THE ISSUES ARE RESOLVING. CULTURES WERE DONE ON (B)(6) 2019 AND THE PATIENT WAS FOUND TO HAVE

  Patient problems: Unspecified Infection

  MAUDE report 8637000 ↗