Arthrex® AR-13200ST-12.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867009660), received between May 24, 2018 and Jun 14, 2024 — classified as 1 injury, 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 18, 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.

• MalfunctionJun 14, 2024Break; Break

  HTO WAS COMPLETED AND FAILED AFTER 6 MONTHS BREAKING 4 SCREWS.

  Patient problems: Failure of Implant

  MAUDE report 19537690 ↗
• InjuryMay 24, 2018Material Rupture

  IT WAS ORIGINALLY REPORTED THAT THERE WAS A BREAKDOWN OF MATERIAL. FOLLOW-UP INVESTIGATION: PROGRESSIVE PAIN AND DEFORMITY TIBIAL OSTEOTOMY. ON (B)(6) 2017 TIBIA OSTEOTOMY AND ARTHREX LOCKED PLATE SYNTHESIS 4 HOLES. 45 DAYS OF CRUTCHES STARTING PARTIAL LOAD AFTER THREE WEEKS. ON (B)(6) 2017 RADIOLOGICAL EVIDENCE OF PARTIAL CONSOLIDATION. BEGINNING OF (B)(6) 2017, SATISFACTORY EVOLUTION AND SUDDENLY FELT A CRACK AND PAIN IN THE LEFT KNEE WITHOUT RESTING ON LOWER LEFT LIMB. AFTER THIS EPISODE PATIENT BEGAN TO FEEL PAIN INSTABILITY AND NOTICED THAT PATIENT AGAIN HAD THE DEFORMITY IN VARUS. PERFORMED SIMPLE RADIOGRAPHIC EXAMINATION AND TOMOGRAPHY. FOLLOW-UP INVESTIGATION:THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2017; THE RUPTURE OCCURRED 45 DAYS POST OP. DATE THE IMPLANT WAS REMOVED (B)(6) 2017. PATIENT: (B)(6) MALE.

  Patient problems: Pain

  MAUDE report 7540111 ↗