Arthrex® AR-9555-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867062474), received between Feb 3, 2020 and Apr 8, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 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.

• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 36 CAME LOOSE FROM THE SUTURECUP AND COULD NOT BE SEPARATED. THE TRIAL CA ADAPTER WAS PLACED IN THE SUTURECUP AND THE TRIAL CA HEAD WAS PLACED. AN X-RAY WAS TAKEN, AND IT WAS DETERMINED THAT THE CA HEAD WAS THE APPROPRIATE SIZE. THE TRIALS WERE REMOVED. THE STEM/CUP IMPACTOR HANDLE WAS THREADED INTO THE CA ADAPTER. THE TAB OF THE CA ADAPTER WAS ALIGNED WITH THE LATERAL SLOT OF THE SUTURECUP. THE IMPLANT WAS IMPACTED INTO THE SUTURECUP. THE CA HEAD WAS IMPACTED WITH THE GLENOSPHERE IMPACTOR MAKING SURE THE HOOD OF THE HEAD WAS LATERAL. THE CA ADAPTER CAME LOOSE FROM SUTURECUP. THE SURGEON ASKED FOR A NEW CA ADAPTER AND A CA HEAD AS THEY COULD NOT BE SEPARATED. A SECOND AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER WAS PLACED ON THE IMPACTOR HANDLE AND WAS IMPACTED INTO THE SUTURECUP. THE GLENOSPHERE IMPACTOR WAS USED AS WELL TO SEAT THE ADAPTER INTO THE SUTURECUP BUT WITH LITTLE EFFORT, THE CA ADAPTER COULD BE PULLED FROM THE SUTURECUP. THE SURGEON WAS ABLE TO SEPARATE THE FIRST SET OF IMPLANTS AND TRIED AGAIN TO IMPACT THE CA ADAPTER INTO THE SUTUR

  Patient problems: Failure of Implant

  MAUDE report 19063083 ↗
• InjuryMay 20, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL REVERSE SHOULDER PROCEDURE WITH MODIFIED GLENOID SYSTEM IN (B)(6) 2019. THE PATIENT HAD RECENTLY UNDERGONE A REVISION PROCEDURE ON (B)(6) 2020 DUE TO PAIN AND CONSTRUCT DISLOCATION. AT THE (B)(6) REVISION, THE HUMERAL INSERT WAS EXPLANTED AND A SPACER AND NEW INSERT WERE IMPLANTED. THE (B)(6) 2020 REVISION WAS REPORTED UNDER CASE (B)(4). ON (B)(6) 2020, THE PATIENT HAD A THIRD PROCEDURE DUE TO NEUROPATHY; THE FOLLOWING DEVICES WERE ALL EXPLANTED: IMPLANTS: AR-9503S-03C (LOT 19.00210), AR-9555-06 (LOT 16.01037), AR-9564-2436-LAT (LOT 19.00689) AND AR-9560-24 (LOT 02191932) AND 4 SCREWS: AR-9563-16, AR-9563-28 (QTY2) AND AR-9563-20 TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING DEVICES: AR-9502-36ARCA (LOT 18.00755) AND AR-9550-19RCA (LOT 10071328).

  Patient problems: Joint Dislocation; Neuropathy; Pain

  MAUDE report 10074336 ↗
• InjuryFeb 3, 2020Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION REVERSE TOTAL SHOULDER TOOK PLACE ON (B)(6) 2020. THE REP REPORTED THE REVISION PROCEDURE WAS DUE TO A HIGH SUSPICION OF AN INFECTION, AND THE BASEPLATE LOOSENING. PRIOR TO THE REVISION PROCEDURE THE PATIENT WAS EXPERIENCING PAIN AND SWELLING AROUND THE SURGICAL SITE. X-RAYS WERE TAKEN DURING A FOLLOW-UP VISIT AND REVEALED THE LOOSENED BASEPLATE. CULTURES WERE TAKEN DURING THE REVISION PROCEDURE AND SENT FOR TESTING. AT THIS TIME AN INFECTION HAS NOT BEEN CONFIRMED. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE REP REPORTED AT THIS TIME THE DATE OF THE PRIMARY SURGERY, AND FULL LIST OF ARTHREX PRODUCT IMPLANTED DURING THE PRIMARY PROCEDURE IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE FOLLOWING ARTHREX PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9503-3633-3 / LOT: 18.00158 / QTY.: 1, AR-9501-05P / LOT: UNKNOWN / QTY.: 1, AR-9555-06 / LOT: 18.01505 / QTY.: 1, AR-9502F-36CPC / LOT: 18.00745 / QTY.: 1, AR-9564-2433-LAT / LOT: 17.04762 / QTY.: 1, AR-9563-16 / LOT: 18.00182 / QTY.: 1. AN ARTHREX BASEPLATE AND SCREW WERE ALSO REMOVED. HOWEVER, THE PART AND LO

  Patient problems: Pain; Swelling

  MAUDE report 9659089 ↗
• InjuryFeb 3, 2020Device Slipped

  IT WAS REPORTED THAT A PATIENT WAS ORIGINALLY OPERATED ON USING THE ARTHREX REVERSE SHOULDER ON (B)(6) 2018. THE PATIENT ORIGINALLY HAD A SMALL BASEPLATE, 36 +4 GLENOSPHERE, SIZE 8 STEM, PLUS 6 SPACER, 20 CENTRAL SCREW, 2- 30MM PERIPHERAL SCREWS AND A PLUS 3 POLY INSERT IMPLANTED. IN (B)(6) 2019, THE PATIENT CAME TO THE SURGEON'S OFFICE COMPLAINING OF PAIN AND LACK OF MOTION. THEY DECIDED TO REVISE THE PATIENT. THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2019. THE REP REPORTED DURING THE REVISION PROCEDURE, IT WAS CLEARLY OBVIOUS THAT THE BASEPLATE AND SCREWS HAD PULLED OUT OF THE FACE OF THE GLENOID. THE SURGEON REMOVED THE POLY, SPACER, BASEPLATE, SCREWS AND GLENOSPHERE, AND IMPLANTED AN AUGMENTED EXACTTECH GLENOID IMPLANT AND GLENOSPHERE. ONCE THAT WAS COMPLETED, THE SURGEON IMPLANTED A PLUS 12 ARTHREX SPACER AND A PLUS 3 POLY LINER ONTO THE EXISTING SIZE 8 STEM AND 36 CUP. THE IMPLANTS WENT IN WITHOUT ANY PROBLEM AND THE SURGEON WAS VERY PLEASED WITH THE POST OPERATIVE RESULTS. THE SURGEON CHOSE TO KEEP THE IMPLANTS THAT WERE EXTRACTED AND EXPECTS THE PATIENT TO DO WELL. ADDITIONAL INFORMATION RECEIVED ON 01/06/2020: THE REP REPORTED THEY DO NOT HAVE ACCESS TO THE PART OR LOT N

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9659050 ↗