Arthrex® AR-9165-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867057937), received between Mar 21, 2019 and Aug 11, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN ANATOMICAL SHOULDER PROSTHESIS WITH UNIVERSAL GLENOID THE BASE PLATE COULD NOT BE IMPLANTED COMPLETELY. THE SURGEON REPLACED THE PERIPHER AND CENTRAL SCREW WITHOUT SUCCESS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6) 31-JUL-2025: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED BASE PLATE WAS INITIALLY IMPLANTED FOUR YEARS AGO. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY 3 MONTHS AGO WHERE THE INLAY AR-9121-02 WAS REVISED. THE PATIENT CONTINUED TO HAVE ISSUES AND UNDERWENT THE SECOND REVISION ON (B)(6) 2025. DURING THE REVISION THE INITIALLY REPORTED EVENT HAS BEEN IDENTIFIED AND THE SURGEON REVISED THE BASE PLATE AND 3 SCREWS.

  Patient problems: Failure of Implant

  MAUDE report 22771540 ↗
• InjuryMar 14, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PROSTHESIS HAD TO BE REMOVED AFTER 5 YEARS AS THE GLENOID SPHERE BECAME LOOSENED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 11-MAR-2024: FURTHER INFORMATION WERE PROVIDED THAT ONLY THE GLENOSPHERE BECAME LOOSENED. THE PLATE AND SCREWS DID NOT HAVE ANY ISSUES BUT WERE REPLACED DURING THE REVISION INCLUDING THE INLAY AND THE GLENOSPHERE.

  Patient problems: Failure of Implant

  MAUDE report 18905952 ↗
• InjuryFeb 26, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A REVISION OF AN ECLIPSE WITH UNIVERSAL GLENOID WAS NECESSARY DUE TO WEAR OF THE POLYETHYLENE GLENOID OF THE UNIVERSAL GLENOID BASE PLATE. IT WAS FURTHER REPORTED THAT THE ISSUE CAUSE A STRONG METALLOSIS DUE TO THE METAL TO METAL FRICTION. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: CD-9341-16, ECLIPSE HEAD, SIZE 41/16 TINBN COATED AR-9300-41CPC ECLIPSE TRUNION,41 MM TPS CTD AR-9301-02 ECLIPSE CAGE SCREW M, 35MM AR-9120-01 UNIVERSAL GLENOID - BASEPLATE SMALL AR-9165-20 UNIVERSAL GLENOID - CENTRAL SCREW 20MM 2X UNKNOWN PERIPHERAL SCREWS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18780030 ↗
• InjuryOct 20, 2023Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INITIAL SURGERY ON (B)(6) 2023 THE PATIENT DEVELOPED A SEVERE INFECTION WHICH AFFECTED THE PATIENT FOR 6 MONTHS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE INVOLVED IMPLANTS. . NO FURTHER INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 17976814 ↗
• InjuryMay 9, 2022Degraded

  IT WAS REPORTED THAT ONE YEAR AFTER THE IMPLANTATION OF A RIGHT SHOULDER TOTAL ENDO-PROSTHESIS ECLIPSE ON (B)(6) 2016, POLYETHYLENE DEGRADATION WAS IDENTIFIED POST-OPERATIVELY. THIS RESULTED IN A BONE DEFECT WHICH LED TO A REVISION SURGERY TO CHANGE THE IMPLANT TO AN INVERSE PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14337497 ↗
• InjuryNov 23, 2020Break

  IT WAS REPORTED THAT DURING A (B)(6) 2020 REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE THE FOLLOWING ISSUES OCCURRED WITH TWO ARTHREX INSTRUMENTS: INSTRUMENT 1: THE MEDIUM T-15 DRIVER (AR-9545-T15-02 #8001928) HAS BEEN COMPROMISED. WHEN TRYING TO EXTRACT THE CENTRAL SCREW FROM A UNIVERSAL GLENOID, THE TIP OF THE DRIVER BECAME TWISTED AND A SMALL PIECE BROKE OFF INTO THE HEAD OF THE CENTRAL SCREW. THERE WAS A 5 MINUTE DELAY IN SURGERY AS THE SCREW HEAD COULD NO LONGER BE ACCESSED. THE SURGEON USED OSTEOTOMES AROUND THE PERIPHERY OF THE BASEPLATE TO EVENTUALLY EXTRACT THE BASEPLATE AND CENTRAL SCREW AS ONE PIECE. THE INSTRUMENT BROKE INTO TWO PIECES. BOTH PIECES WERE RECOVERED, BUT THE SMALLER PIECE WAS LODGED INTO THE CENTRAL SCREW IMPLANT WHICH WAS NOT AVAILABLE FOR RETURN. THERE WAS NO UNPLANNED INCISION. A SECOND SURGERY IS NOT NECESSARY. DEVICE WILL BE RETURNING FOR EVALUATION. THE EVENT DID NOT OCCUR DURING THE INITIAL USE OF THE DEVICE. INSTRUMENT 2: THE TRINITY BASEPLATE IMPACTOR (AR-9165CDG #(10)051917) HAS BEEN COMPROMISED. THE SURGEON ENGAGED THE ALREADY IMPLANTED BASEPLATE WITH THE IMPACTOR SO THAT IMPACTION MIGHT DISRUPT THE BONY BOND WITH THE BASEPLATE. AFTER

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10884304 ↗
• InjuryFeb 3, 2020Appropriate Device Problem Term/Code Not Available

  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. THE 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 NU

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9659039 ↗
• InjuryMar 21, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TSA PROCEDURE ON (B)(6) 2018. 9 MONTHS POST-OP, ON (B)(6) 2019, THE PATIENT WAS SEEN BY THEIR SURGEON FOR A FOLLOW-UP VISIT WHERE AN X-RAY WAS TAKEN TO DETERMINE PROGRESS. THE X-RAY SHOWED THAT THE BASEPLATE AND GLENOSPHERE WERE DISLOCATED. THE PATIENT STATED THAT NO TRAUMA HAD OCCURRED. A COPY OF THE X-RAY IS UNABLE TO BE OBTAINED. A REVISION SURGERY TOOK PLACE ON (B)(6) 2019 AND THE FOLLOWING DEVICES WERE ALL EXPLANTED: AR-9145-30 / LOT: 170156313, AR-9145-36 / LOT: 170139313, AR-9504M / LOT: 140119609, AR-9503M-06 / LOT: 160010109, AR-9120-01 / LOT: 170145515, AND AR-9165-20 / LOT: 150008108. THE SURGEON SWITCHED TO AN RTSA AND IMPLANTED THE FOLLOWING: AR-9502-39ARCA / LOT: 261519 AND AR-9550-19RCA / LOT: 10031668. ADDITIONAL INFORMATION PROVIDED 3/29/2019: THE AR-9145-30 SCREW BROKE UPON REMOVAL OF HARDWARE. TIP WAS RETRIEVED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8440419 ↗