Arthrex® AR-9140-17PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867057661), received between Jan 30, 2023 and Jan 30, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Patient Device Interaction Problem

  ON JANUARY 9TH, 2023, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED OF A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY. PATIENT UNDERWENT TOTAL SHOULDER PROCEDURE ON (B)(6) 2021, IN WHICH THE ARTHREX UNIVERS APEX IMPLANT SET WAS USED. A YEAR LATER, PATENT COMPLAINT OF PAIN AND MOTION LIMITATION. ON (B)(6) 2022, A REVISION TOOK PLACE FOR ARTHROSCOPIC DEBRIDEMENT AND NERVE RELEASE OF THE SUPRASCAPULAR NOTCH. NO ADDITIONAL INFORMATION HAS BEEN REPORTED AS OF NOW. ADDITIONAL INFORMATION RECEIVED ON 1/10/2023: THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE ORIGINAL PROCEDURE: ARTHREX UNIVERS LL HUMERAL HEAD, PART NUMBER: AR-9140-17P, LOT: 170024021. ARTHREX UNIVERSE APEX HUMERAL STEM, PART NUMBER: AR-9100-05S, LOT: 10193799. UNIVERS VAULTLOCK GLENOID SMALL PART NUMBER: AR-9106-01, LOT: 1027262023. ALL REMAIN IMPLANTED IN THE PATIENT, AS NOTHING WAS EXPLANTED DURING THE REVISION SURGERY. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16263244 ↗