Arthrex® AR-9120-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867057357), received between Oct 30, 2019 and Nov 17, 2025 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING OF THE GLENOID COMPONENT AND PERSISTENT PAIN REPORTED BY THE PATIENT. INTRAOPERATIVELY, PRONOUNCED METALLOSIS WAS DETECTED. THE POLYETHYLENE (PE) INLAY EXHIBITED SIGNIFICANT EROSION, AND THE UNIVERSAL BASEPLATE WAS FOUND TO BE PARTIALLY ERODED AS WELL. ALL COMPONENTS AND ASSOCIATED FRAGMENTS WERE REMOVED. SUBSEQUENTLY, A REVERSE SHOULDER PROSTHESIS (UNIVERS REVERS COMBINED WITH THE MODULAR GLENOID SYSTEM) WAS IMPLANTED.

  Patient problems: Metal Related Pathology

  MAUDE report 23569528 ↗
• 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 DW 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 22771546 ↗
• 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 18906168 ↗
• InjuryJan 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER AN INITIAL SHOULDER SURGERY ON (B)(6) 2023 THERE WAS A DISLOCATION OF THE GLENOSPHERE AR-9504M-04 (LOT: 19.00069) FROM THE UNIVERSAL BASEPLATE AR-9120-02 (LOT: 19.04364) AFTER THE SURGERY, WHICH RESULTED IN A REVISION SURGERY ON (B)(6) 2023. DURING THE REVISION SURGERY, THE HUMERAL INLAY AND THE GLENOSPHERE WERE REMOVED AND DISPOSED. THE BASEPLATE WAS LEFT IN THE PATIENT. A NEW GLENOSPHERE AND HUMERAL INLAY WERE IMPLANTED. DURING THE REVISION SURGERY, THE SURGICAL STEPS FOR TISSUE CLEARANCE AROUND THE BASEPLATE WERE ADEQUATELY PERFORMED AND A NEW GLENOSPHERE WAS IMPLANTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 18463580 ↗
• InjuryJan 2, 2024Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth; Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING AN INVERSE PROSTHESIS SURGERY THE SCREWS AR-9145-30 (LOT: 22.02176) AND AR-9165-20NL (LOT: 15019430) COULD NOT BE TIGHTENED WHEN THE BASE PLATE AR-9120-02 (LOT: 22.03081) AND THE GLENOSPHERE AR-9504M-04 (LOT: 22.02710) WERE IMPLANTED. AS A RESULT, THE GLENOID DID NOT HOLD AND HAD TO BE REMOVED AGAIN. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. A SECOND SURGERY WAS REQUIRED ON (B)(6) 2023. UPDATE AVOE 07-DEC-2023. IT WAS CONFIRMED THAT THE SECOND SURGERY WAS REQUIRED DUE TO THE FAILURE OF THE SCREWS, WHICH DIDN`T LOCK LIKE NORMALLY.

  Patient problems: Failure of Implant

  MAUDE report 18429324 ↗
• InjuryApr 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING OF THE BASEPLATE. IT WAS FURTHER REPORTED THAT A CAUDAL SCREW BREAKAGE AND A METALLOSIS OCCURRED. A RESECTION ARTHROPLASTY WAS PERFORMED TO RESOLVE THE ISSUE. 17-APR-2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE BROKEN SCREW HAD THE PART NUMBER AR-9145-36.

  Patient problems: Failure of Implant

  MAUDE report 16838664 ↗
• InjuryApr 28, 2023Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING OF THE BASE PLATE. IT WAS FURTHER REPORTED THAT A SCREW BROKE CAUDAL AND INLAY SHOWED ABRASION. THE GLENOID COMPONENT WAS REMOVED AN A CEREMENT FILLING WAS DONE. NO FURTHER INFORMATION RECEIVED. 17-APR-2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT AN AR-9145-30 WAS THE BROKEN SCREW.

  Patient problems: Failure of Implant

  MAUDE report 16838378 ↗
• InjuryDec 21, 2021Break; Output Problem; Noise, Audible

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2020 DUE TO POLYETHYLENE ABRASION IN COMBINATION WITH METALLOSIS AND OSTEOLYSIS. THE INITIAL SURGERY TOOK PLACE IN (B)(6) 2016. FROM SUMMER 2019 ON THE PATIENT SUFFERED FROM PAIN, RESTRICTION OF SHOULDER MOVEMENT, AND A STRONG SQUEAKING NOISE OCCURRED WHEN MOVING THE SHOULDER. DURING THE REVISION SURGERY IT WAS NOTICED THAT THE DEVICES DIDN`T SHOW ANY SIGN OF LOOSENING AND THE POSITION WAS STILL CORRECT. THE POLYETHYLENE PART OF THE DEVICE SHOWED A HIGH PE CONSUMPTION AND IS MASSIVELY THINNED OUT. IN THE FREE JOINT SPACE, A BROKEN OFF PART OF THE POLYETHYLENE WAS FOUND. OSTEOLYSIS COULD BE OBSERVED AT THE UPPER GLENOID POLE OF APPROX. ONE CUBIC CENTIMETER TO THE PROXIMAL SCREW CAUSED BY THE METALLOSIS. THE PATIENT WAS TREATED BY REPLACING THE POLYETHYLENE INLAY WITH A NEW ONE OF SIZE MEDIUM. REMOVAL OF THE OLD AN APPLICATION OF A NEW ANTI-ALLERGENIC ECLIPSE DOME AS USUAL OF SIZE 47/16. IN ADDITION A RESECTION OF ANY METALLIC ALTERED SOFT TISSUE AS WELL AS SYNOVIAL TISSUE WAS PERFORMED. . THE SURGERY WAS FINISHED SUCCESSFULLY. THE PATIENT REPORTS A PERMANENT LIMITATION OF MOVEMENT SINCE THE INCIDENT.

  Patient problems: Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 13053756 ↗
• 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 12506400 ↗
• InjuryJul 27, 2021Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN ASEPTIC LOOSENING OF THE DEVICE AND A PROGRESSIVE POLYETHYLENE ABRASION WITH PRONOUNCED METALLOSIS. THE COMPLETE SHOULDER PROSTHESIS INCLUDING HUMERUS AND GLENOID COMPONENTS WAS CHANGED TO INVERSE SHOULDER PROSTHESIS.

  Patient problems: Abrasion; Failure of Implant; Metal Related Pathology

  MAUDE report 12231613 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED AFTER THE PRIMARY IMPLANTATION WHICH WAS PERFORMED IN 2015. THE ECLIPSE PROSTHESES WAS REMOVED AND REPLACED WITH A UNIVERS REVERS PROSTHESES. NO FURTHER INFORMATION WERE CURRENTLY PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9659115 ↗
• InjuryDec 4, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN ECLIPSE SURGERY TOOK PLACE ON (B)(6) 2016. ACCORDING TO THE SURGEON, THE PATIENT IS VERY ATHLETIC AND ACTIVE. HE IS BOXING AND PLAYING TENNIS. THE PATIENT HAD PAIN AND MOVEMENT RESTRICTIONS AFTER THE SURGERY. THE GLENOID WAS CONSPICUOUS WITH SUSPICION OF METAL CONTACT WITH THE SPHERICAL CAP. THE SURGEON DECIDED ON A REVISION SURGERY. THE IMPLANTS AND THE PROSTHESIS WERE COMPLETELY REMOVED AND AN INVERSE PROSTHESIS WAS IMPLANTED BY ANOTHER MANUFACTURER. UNFORTUNATELY, THE CUSTOMER CANNOT GIVE US THE PART NUMBER OF THE PE INLAY. THE CUSTOMER HAS FORWARDED THE EXPLANTED PARTS TO A LABORATORY FOR CULTURE TESTING. THE LABORATORY DISCARDED ALL PARTS AFTER THE TESTING. FOLLOWING ARTHREX DEVICES WERE EXPLANTED: AR-9120-02, AR-9121-02, CD-9347-18, AR-9300-47CPC & ARTHREX PE-INLAY (PART NUMBER UNKNOWN). IT IS NOT POSSIBLE FOR THE CUSTOMER TO PROVIDE US THE BATCH NUMBERS, NO FURTHER INFORMATION RECEIVED.

  Patient problems: Pain

  MAUDE report 9409881 ↗
• InjuryDec 2, 2019Noise, Audible

  IT WAS REPORTED THAT IN (B)(6) 2016 THE INITIAL ECLIPSE SURGERY WAS PERFORMED ON A MALE PATIENT. THE ARTHREX HUMERAL HEAD - AR-9349-18 AND THE ARTHREX GLENOID INLAY AR-9121-02 WERE IMPLANTED. THE SURGEON REQUESTED THE PATIENT TO BE CHECKED AFTER 3 YEARS. THE DOCTOR DETERMINED THAT THE PE INLAY WAS ABNORMAL. IN ADDITION, THE PATIENT ALSO HEARD METALLIC CLACKING. THE SURGEON THEREFORE DECIDED ON A REVISION SURGERY. THE INLAY AND THE HEAD WERE REMOVED AND REPLACED BY NEW DEVICES. THE LAXITY WAS GOOD. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED. ACCORDING TO THE SURGEON, THE MALE PATIENT IS ATHLETIC AND REGULARLY GOES TO THE GYM. NEVERTHELESS, HE IS NOT EXCESSIVELY ACTIVE. IN ADDITION THE HUMERAL HEAD WAS NOT THE ISSUE BUT SINCE IT WAS ALSO REMOVED THE CUSTOMER WANTS TO SEND THE DEVICE IN.

  Patient problems: No Code Available

  MAUDE report 9396446 ↗
• InjuryOct 30, 2019Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT HAD A PRIMARY REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2019. THE PATIENT RETURNED TO THE OR FOR A REVISION PROCEDURE ON (B)(6) 2019 DUE TO THE IMPLANTED GLENOSPHERE DISASSOCIATING FROM THE BASEPLATE. DURING THE ORIGINAL PROCEDURE, THE CENTRAL SCREW DEPTH GAUGE WAS USED TO ENSURE THAT THE CENTRAL SCREW WAS FULLY SEATED. AFTER GLENOSPHERE IMPACTION, THE GLENOSPHERE FORCEPS WERE USED IN MULTIPLE PLANES TO ENSURE ENGAGEMENT OF THE MORSE TAPER. DURING THE REVISION PROCEDURE THE ORIGINAL GLENOSPHERE (AR-9120-02 / LOT: 18.01057) AND BASEPLATE (AR-9504L-04 / LOT: 18.00719) WERE EXPLANTED, AND THE SURGEON IMPLANTED A MGS BASEPLATE (AR-9560-28-2 / LOT: 5642) AND GLENOSPHERE (AR-9564-2842-LAT / LOT: 18.00802) IN ITS PLACE. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON, AND TOOK PLACE AT THE SAME FACILITY. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE: AR-9120-02 // LOT: 18.01057 // QTY.: 1, AR-9145-24 // LOT: 18.00674 // QTY.: 1, AR-9145-30 // LOT: 18.01275 // QTY.: 1, AR-9165-20NL // LOT: 10247862 // QTY.: 1, AR-9501-12P // LOT: 18.00906 // QTY/: 1, AR-9502F-42CPC // LOT: 160037703 // QTY.: 1, AR-9503L-03C // LOT

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 9254820 ↗