Arthrex® AR-9100-12SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867134706), received between Dec 16, 2019 and Sep 2, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2020Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A SURGICAL OUTCOME SYSTEM PATIENT (146155) HAD UNDERGONE A REVERSE SHOULDER ARTHROPLASTY (B)(6) 2019. THE PATIENT SUFFERED A TRAUMATIC PERIPROSTHETIC FRACTURE REQUIRING AN EXCHANGE TO A LONG STEM. THE PATIENT HAD BEEN SEEN IN CLINIC (B)(6) 2020 FOR A RECENT FALL WITH NO GIVEN DATE. THE REVISION TO PERFORM THE EXCHANGE OOK PLACE (B)(6) 2020. A STANDARD OSTEOTOME WAS USED FOR REMOVAL OF HE AR-9100-12S UNIVERS APEX HUMERAL STEM, WHICH WAS LOOSE BECAUSE OF THE FRACTURE. THE DEVICE LOT NUMBER WAS NOT PROVIDED. THE PATIENT BONE QUALITY WAS REPORTED TO BE AVERAGE. THERE WERE NO COMPLICATIONS DURING REMOVAL.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 10482288 ↗
• InjuryMay 14, 2020Loose or Intermittent Connection

  IT WAS REPORTED VIA THE SURGICAL OUTCOME SYSTEM THAT A PATIENT HAD PREVIOUS SHOULDER PROCEDURE. THE PATIENT EXPERIENCED LOOSENING OF THE IMPLANT ON THE HUMERAL SIDE THAT WAS UNRELATED TO ANY TRAUMA. THE PATIENT UNDERWENT A REVISION TO A DIFFERENT TYPE OF ARTHROPLASTY. PATIENT IS ONGOING AND IMPROVING. NO FURTHER INFORMATION WAS PROVIDED FROM THE SURGICAL OUTCOME SYSTEM. FURTHER INVESTIGATION IS IN PROCESS. ADDITIONAL INFORMATION OBTAINED 4/14/20: PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY AND OPEN BICEPS TENOSIS PROCEDURE ON (B)(6) 2016. PATIENT BEGAN EXPERIENCING PAIN ISSUES IN (B)(6) 2018. ON (B)(6) 2020 THE SAME SURGEON PERFORMED A REVISION PROCEDURE AT THE SAME FACILITY. THE REVISION PROCEDURE WAS AN OPEN SURGERY, REVISION TO REVERSE REPLACEMENT. EXPLANTED PART NUMBERS ARE NOT YET KNOWN. PATIENT STUDY ID IS (B)(6). ADDITIONAL INFORMATION OBTAINED 4/22/20: THE FOLLOWING ARE THE IMPLANT PART NUMBERS FROM THE ORIGINAL (B)(6) 2016 PROCEDURE. ALL OF THE DEVICES LISTED WERE EXPLANTED DURING THE REVISION PROCEDURE ON (B)(6) 2020. THE DEVICE DISPOSITION IS UNKNOWN. AR-9106-03 UNIVERS VAULTLOCK GLENOID (LOT 1027261550}. AR-9150-19P UNIVERS II HUMERAL HEAD (LOT 150084918}. AR-

  Patient problems: Failure of Implant; Pain

  MAUDE report 10055609 ↗
• InjuryDec 16, 2019Loose or Intermittent Connection

  IT WAS REPORTED VIA THE SURGICAL OUTCOME SYSTEM THAT A PATIENT IN THE ARTHREX SHOULDER ARTHROPLASTY STUDY HAD A RIGHT TOTAL SHOULDER ARTHROPLASTY PROCEDURE (B)(6) 2017. THE PATIENT WAS RECENTLY COMPLAINED OF PAIN AND WAS DIAGNOSED WITH LOOSENING OF THE HUMERAL PROSTHESIS. THE PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2019 DURING WHICH ONLY THE HUMERAL COMPONENTS OF THE TOTAL SHOULDER ARTHROPLASTY WERE EXPLANTED. THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED DURING THE 2019 PROCEDURE: AR-9156-22P HUMERAL HEAD (LOT 160084912) AND AR-9100-12S HUMERAL STEM (LOT 10064889). THE HUMERAL COMPONENTS WERE REPLACED WITH ANOTHER MANUFACTURERS PRODUCT. AT THIS TIME THE DISPOSITION OF THE EXPLANTED DEVICES IS UNKNOWN. ADDITIONAL INFORMATION OBTAINED 12/2/2019: FACILITY HAS CONFIRMED THAT THE DEVICE IS NO LONGER AVAILABLE TO RETURN FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 9473272 ↗