Arthrex® AR-9100-11PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867057142), received between May 28, 2020 and May 28, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2020Break; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT ON (B)(6) 2014 A TOTAL SHOULDER PROSTHESIS FROM ARTHREX THE UNIVERSAL-GLENOID WAS IMPLANTED INTO THE PATIENT. DURING THE YEAR 2018 IT WAS SHOWN ON X-RAY PICTURES THAT THE PLASTIC INLAY OF THE IMPLANT WAS WORN OUT. THEREFORE A REVISION SURGERY WAS PERFORMED WHICH CONFIRMED THAT THE PLASTIC INLAY WAS EXFOLIATED, THINNED AND BROKEN. NO FURTHER INFORMATION WERE PROVIDED. UPDATE 18-MAY-2020: FURTHER INFORMATION WERE PROVIDED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. THE INITIAL RESULTS STATED THAT THE PATIENT HAD THE FEELING THAT THE SHOULDER IS JUMPING AND MAKING NOISE. WHICH WAS CONFIRMED DURING THE CLINICAL EVALUATION. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO A LOOSENING SHAFT AND INLAY DEGRADATION ON THE RIGHT SHOULDER. THE PROSTHESIS WAS REPLACED WITH AN INVERSE PROSTHESIS AND THE SHAFT WAS ALSO EXCHANGED.

  Patient problems: No Code Available

  MAUDE report 10096434 ↗