Arthrex® AR-9146-18PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867057791), received between Oct 25, 2018 and Dec 27, 2021 — classified as 4 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2021Therapeutic or Diagnostic Output Failure

  ON (B)(6) 2021, IT WAS REPORTED BY A SALE REPRESENTATIVE VIA THE PHONE THAT AR-9100-10S, AR-9146-18P AND AR-9105-03 WERE EXPLANTED (B)(6) 2021 DUE TO PAIN AND ROTATOR CUFF FAILURE CONFIRMED BY IMAGING. THESE DEVICES WERE IMPLANTED ON (B)(6) 2015 @ (B)(6) HOSPITAL . THE CASE WAS COMPLETED USING A COMPETITORS REVERSE TOTAL SHOULDER SYSTEM.

  Patient problems: Pain

  MAUDE report 13087676 ↗
• InjuryApr 7, 2021Material Split, Cut or Torn

  IT WAS REPORTED A PATIENT HAD A REVISION SURGERY. THE ORIGINAL SURGERY DATE WAS (B)(6) 2019. THE PATIENT FELL ON (B)(6) 2020 AND SUFFERED FROM A ROTATOR CUFF TEAR. THIS WAS THE PURPOSE OF THE REVISION. THE FOLLOWING PARTS WERE REMOVED AR-9100-06S, AR-9146-18P AND AR-9106-02. THE TOTAL SHOULDER REPLACEMENT WAS REMOVED AND REPLACED TODAY. MALE PATIENT (B)(6) YEARS OF AGE. THE REVISION CASE WAS COMPLETED AND THE PATIENT IS NOW FINE TO DATE.

  Patient problems: Fall

  MAUDE report 11627257 ↗
• InjuryNov 21, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT THE PATIENT HAD COMPLICATIONS RELATED TO MOTION LOSS. ADDITIONAL INFORMATION WAS OBTAINED THAT THE PATIENT HAD AN ARTHREX APEX UNIVERSE TOTAL SHOULDER SYSTEM IMPLANTED DURING A (B)(6) 2018 PROCEDURE. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE (B)(6) 2018 PROCEDURE: UNIVERSE APEX HUMERAL STEM AR-9100-08S (LOT 10070616), UNIVERSE II HUMERAL HEAD AR-9146-18P (LOT 10129357), UNIVERSE VAULTLOCK GLENOID MEDIUM AR-9106-02 (LOT 1027261721) AND FIBERTAPE TENDON COMPRESSION BRIDGE KIT WITH JUMPSTART DRESSING AR-7297 (LOT 10197428). DURING PATIENT'S (B)(6) 2019 FOLLOW UP WITH SURGEON IT WAS NOTED THAT THE PATIENT HAD A LACK OF HEALING OF HER SUBSCAPULARIS AND HAS BEEN SCHEDULED FOR REVISION SURGERY ON 10/9/2019. SURGEON HAS STATED THAT THE PATIENT HAD AN ANATOMIC ARTHROPLASTY WITH FAILURE OF SUBSCAPULARIS HEALING. WHICH WAS NOT ARTHREX DEVICE RELATED. A FOLLOW UP WILL BE DONE AFTER THE REVISION TAKES PLACES TO CONFIRM IF ANY ARTHREX PRODUCTS ARE EXPLANTED. ADDITIONAL INFO OBTAINED 10/2/2019: THE FOLLOWING PARTS WERE IMPLANTED DURING THE (B)(6) 2019 PROCEDURE: AR-9106-02, UNIVERSE VAULTLOCK GLENOID MEDIUM, LOT 1027261721, AR-9100-08

  Patient problems: Impaired Healing

  MAUDE report 9353217 ↗
• InjuryOct 25, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A REVISION OF HEMI TSA TO REVERS TSA PROCEDURE, THE KNOB ON THE SLAP HAMMER, AR-9202-14, BROKE OFF ON THE FOURTH ATTEMPT FOLLOWING THE EXTRACTION PROCEDURE STEPS. THE BROKEN PIECE WAS DISCARDED. THE SURGEON USED A BONE HOOK RETRACTOR (NON-ARTHREX) AND A SLOTTED MALLET, AR-9231-21, FROM THE BONE PREP TRAY TO COMPLETE THE EXTRACTION. THE INSTRUMENT BROKE CLEANLY INTO TWO PIECES. ADDITIONAL INFORMATION PROVIDED 9/19/2018: THIS WAS A REVISION FROM A HEMI ARTHROPLASTY WITH AN ARTHREX APEX STEM AND HARDWARE. NO GLENOID IMPLANTS. THE SURGERY WAS PERFORMED BECAUSE THE PATIENT FELL AND TORE HER ROTATOR CUFF A FEW MONTHS AGO. THE SURGEON FELT THAT A REVERSE TOTAL SHOULDER ARTHROPLASTY WOULD HAVE THE BEST OUTCOME FOR THE PATIENT. ZIMMER IMPLANTS WERE USED FOR THE REVERSE PROCEDURE. ADDITIONAL INFORMATION PROVIDED 10/2/2018: THE ORIGINAL DOS WAS (B)(6) 2017. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE ORIGINAL SURGERY AND EXPLANTED DURING THE REVISION: APEX HUMERAL STEM: AR-9100-10S/10128790. HUMERAL HEAD: AR-9146-18P/140107415.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8006640 ↗