Arthrex® AR-9165-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867057920), received between Nov 1, 2016 and Oct 24, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A LOOSENING OF THE ECLIPSE PROSTHESIS LED TO REVISION TO UNIVERS REVERS. THE FOLLOWING DEVICES WERE INITIALLY IMPLANTED: ECLIPSE HEAD, ECLIPSE TRUNION, ECLIPSE CAGE SCREW AND UNIVERSAL GLENOID INLAY. THE UNIVERSAL GLENOID HAD A GOOD ANCHORAGE, SO THE PE WAS REMOVED AND A GLENOSPHERE WAS INSTALLED. ON THE HUMERAL SIDE AN ECLIPSE REMOVED AND UNIVERS REVERS INSTALLED. NO FURTHER INFORMATION RECEIVED. UPDATE 03-OCT-2023: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON THE 20-MAR-2017 AND THE FOLLOWING DEVICES WERE IMPLANTED: AR-9145-30 LOT: 160058310. AR-9165-15 LOT: 160064010. AR-9120-01 LOT: 160061912. AR-9145-36 LOT: 160058410. AR-9121-01 LOT: 160101410. AR-9300-41CPC.

  Patient problems: Failure of Implant

  MAUDE report 17994982 ↗
• MalfunctionSep 21, 2021Break

  IT WAS REPORTED THAT 6 YEARS AFTER THE INITIAL SURGERY, A REVISION SURGERY OF THE ECLIPSE WITH THE UNIVERSAL GLENOID WAS NECESSARY AS THE PATIENT SUFFERED PAIN IN THE SHOULDER JOINT. THE SUB-SCAPULARIS NO LONGER HAD ANY FUNCTION. THEREFORE AN INVERSE PROSTHESIS WAS INDICATED AND A PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. AS THE PATIENT WAS ALLERGIC TO METAL, NO MODULAR CONVERSION OF THE GLENOID COULD BE PERFORMED. THEREFORE THE UNIVERSAL GLENOID AND THE ECLIPSE HAD TO BE REMOVED. THE SURGEON FURTHER REPORTED THAT DARK TRACES WERE IDENTIFIED BELOW THE TRUNION. THE LYSIS FRINGES ARE THE RESULT OF THE PE ABRASION. ONLY SMALL FRAGMENTS OF THE PE INSERT WERE STILL PRESENT. UPDATE 22-FEB-2021: X-RAY PICTURES AND A SURGERY REPORT WAS PROVIDED WITH THE INFORMATION THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017. THE REPORTED EVENT WAS IDENTIFIED ON (B)(6)-2020 VIA SCINTIGRAPHY. UPDATE 26-FEB-2021 : THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Failure of Implant; Foreign Body In Patient; Pain

  MAUDE report 12506414 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO A METALLOSIS THE SHOULDER AND THE ARM OF THE PATIENT TURNED BLACK. THE SURGERY WHICH LED TO THE REPORTED EVENT WAS A SHOULDER PROSTHESIS WHICH WAS PERFORMED ON (B)(6) 2015. ACCORDING TO THE CUSTOMER ARTHREX DEVICES WERE IMPLANTED DURING THE INITIAL SURGERY IN 2015. CURRENTLY IT IS NOT KNOWN IN WHICH HOSPITAL THE INITIAL SURGERY TOOK PLACE. THEREFORE NO FURTHER INFORMATION ABOUT THE DETAILED INCIDENT AND THE USED ARTHREX PART NUMBERS ARE CURRENTLY AVAILABLE. UPDATE 12-OCT-2020: INITIALLY THE LOT NUMBERS WHICH WERE AFFECTED WERE NOT PROVIDED HOWEVER FURTHER INFORMATION WERE NOW PROVIDED THAT THE FOLLOWING PARTS WERE USED DURING THE INITIAL SURGERY 2015: AR-9120-01, LOT: 140113110. AR-9145-30, LOT: 140123108. AR-9504S-04, LOT: 2501212801. AR 9165-15, LOT: 140103207. AR-9145-30, LOT: 2501417704. AR-9502-36CPC, LOT: 140120310. AR -9501-07CPC, LOT: 2501215303. AR-9503S-03, LOT: 140104307. AR-9555-15, LOT:2501215101. AR-7213, LOT: 12812. AR-7200, LOT: 12795. HOWEVER IT COULD NOT BE CONFIRMED WHICH DEVICE HAS LED TO THE REPORTED ISSUE AND IF THE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: Metal Related Pathology; Skin Discoloration

  MAUDE report 10746412 ↗
• InjuryJun 16, 2020Malposition of Device

  IT WAS REPORTED THAT THE SURGEON HAS STATED THAT THE POSITION OF THE IMPLANTED BASE PLATE IS NOT IN A PROPER POSITION AND THEREFORE THE SURGEON DECIDED TO PERFORM A REVISION SURGERY. DURING THE REVISION SURGERY THE SURGEON DECIDED TO MAKE AN EASIER ACCESS TO THE GLENOID TO REPLACE THE WHOLE PROSTHESES. IT WAS FURTHER REPORTED THAT IT WAS FOUND ON THE X-RAY THAT DUE TO THE POSITION OF THE BASE PLATE A SCAPULAR NOTCHING WAS CAUSED. THE FOLLOWING IMPLANTS WERE EXPLANTED: BASE PLATE AR-9500-01 (PART NUMBER UNKNOWN AS THE PROVIDED ONE IS INCORRECT). GLENOSPHERE AR-9504S-04, STOCK AR-9501-08CPC, 2X PERIPHERE SCREWS (LOCKING) (PART NUMBER UNKNOWN), CENTRAL SCREWS (LOCKING) (PART NUMBER UNKNOWN), PE-INLAY (PART NUMBER UNKNOWN). UPDATE 07-JUN-2020: FURTHER INFORMATION WERE PROVIDED THAT THE BASE PLATE WAS NOT OPTIMALLY PLACED AND THE PLATE DID NOT SINK. DURING THE SURGERY IT WAS ALSO DISCOVERED THAT THE PLATE HAD GOOD OSSEOINTEGRATION. THE SIZE THE CENTRAL SCREW IS AN AR-9165-15.

  Patient problems: No Code Available

  MAUDE report 10159980 ↗
• InjuryApr 22, 2020Break; Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2019 A REVERS SHOULDER ARTHROPLASTY WAS PERFORMED. EVERYTHING WENT WELL AND IT WAS FINISHED SUCCESSFULLY. THE SURGEON WAS SATISFIED AFTER THE CASE. THIS WAS ALSO SHOWED ON THE X-RAYS. APPROXIMATELY 6 MONTHS POST-OP THE PATIENT REPORTED SUBSEQUENTLY FAILING WHILE PUTTING ON TROUSERS. HE FELT AN ISSUE. THIS WAS WHEN THE GLENOID SIDE GAVE WAY. IT WAS AN ELECTIVE REVERS AND NOT A FRACTURE REVERS. X-RAYS WERE DONE ON (B)(6) 2020. A REVISION SURGERY IS PLANNED TO BE ON (B)(6) 2020. UPDATE 02-APR-2020: FURTHER INFORMATION WAS RECEIVED: THE REVISION SURGERY WENT AHEAD ON (B)(6) 2020 AFTERNOON. IT WAS REVISED WITH THE NEW MODULAR GLENOID SYSTEM, SUCCESSFULLY USING AN ILIAC CREST GRAFT. EVERYTHING WENT VERY WELL. THE FAILED DEVICES WERE RETRIEVED, HOWEVER BOTH PERIPHERAL SCREWS WERE BROKEN AND THE TIPS REMAIN IN THE PATIENT. BASEPLATE, CENTRAL SCREW & REMAINING PORTION OF PERIPHERAL SCREWS X 2 WILL BE RETURNED ASSEMBLED. ALSO FROM THE HUMERAL SIDE THE CUP AND LINER, WHICH NEEDED TO BE REMOVED FOR ACCESS, WILL BE RETURNED. THERE WAS NO ISSUE WITH THE HUMERAL SIDE, HOWEVER THEY WILL BE RETURNED REGARDLESS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9985425 ↗
• InjuryNov 1, 2016Material Twisted/Bent

  IT WAS REPORTED THAT A MALE PATIENT HAD UNDERGONE A RIGHT REVERSE TOTAL SHOULDER PROCEDURE APPROXIMATELY TWO YEARS PRIOR IN ANOTHER STATE. ON (B)(6) 2016 PATIENT WAS UNDERGOING A PROCEDURE TO REMOVE THE PRIOR IMPLANTS DUE TO INFECTION. DURING THE PROCEDURE SURGEON WAS USING THE AR-8943-10, T15 HEXALOBE SCREWDRIVER ((B)(4)) AND THE THREADS TWISTED MAKING IT NO LONGER USABLE. THEN THE SURGEON USED THE AR-9202-T15H, UNIVERSAL GLENOID T15 LONG DRIVER ((B)(4)) AND FOUND THE THREADS TWISTED RENDERING IT UNUSABLE. THESE DEVICES ARE FROM LOANER SET RAR-9501GS #14. NO PATIENT INJURY REPORTED. THE CASE WAS COMPLETED USING HOSPITAL OWNED SPARE SCREWDRIVERS WHICH WERE ALSO IN BAD CONDITION. INFORMATION OBTAINED 10/13/16: PRIOR TO THE REVISION PROCEDURE PATIENT HAD A NORMAL BLOODWORK IN 2014, ASPIRATION OF 45CC IN (B)(6) 2016 AND POSITIVE TEST FOR PROPIONBACTERIUM ACNES. AT THE TIME OF THE REVISION AN EXTENDED HOLD CULTURE WAS DONE AND READ ON (B)(6) 2016 AS WELL AS (B)(6) 2016 AND IS CURRENTLY ONGOING. NO AEROBES ISOLATED OR ANEROBIC GROWTH OF BACTERIA FOUND. NO EVIDENCE OF MALIGNANCY. THE FOLLOWING PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9504L-04 ((B)(4)), AR-9502-42RCPC ((B)(4

  Patient problems: Unspecified Infection

  MAUDE report 6068926 ↗