Arthrex® AR-9121-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867057425), received between Dec 2, 2019 and Dec 30, 2025 — classified as 12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PE INLAY AR-9121-02 OF THE UNIVERSAL GLENOID GOT WORN OFF, RESULTING IN METAL ON METAL CONTACT BETWEEN ECLIPSE HUMERAL HEAD AND THE BASEPLATE OF THE UNIVERSAL GLENOID. THIS RESULTED IN METALLOSE AND RELATED PROBLEMS REQUIRING A REVISION SURGERY WITH A CONVERSION TO A REVERSE PROSTEHSIS. DURING THE REVISION SURGERY THE ECLIPSE HUMERAL COMPONENTS AND THE REMAINING PARTS OF THE INLAY WERE REMOVED AND PROPER SEATING OF THE UNIVERSAL GLENOID BASEPLATE WAS CONFIRMED. THEN A GLENOSPHERE WAS INSERTED ONTO THE BASEPLATE AND THE UNIVERS REVERS HUMERAL COMPONENTS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 23927389 ↗
• InjuryNov 17, 2025Material Fragmentation; Material Fragmentation

  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 23569538 ↗
• InjuryAug 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY 3 MONTHS AGO, THE SPECIFIC DATE IS UNKNOWN, WHERE THE INLAY AR-9121-02 WAS REVISED AS IT BECAME LOOSE. A SECOND REVISION WAS LATER PERFORMED WHICH IS HANDLED IN (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 22772084 ↗
• InjuryJun 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED FROM AN ECLIPSE + UNIVERSAL GLENOID TO UNIVERS LAPEL WITH UNIVERSAL GLENOID GLENOSPHERE. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2019. THE REVISION SURGERY WAS REQUIRED DUE TO HUMERAL LOOSENING OF THE ECLIPSE PROSTHESIS. ACCORDING TO THE SURGEONS STATEMENT THE IMPLANT WAS ORIGINALLY POORLY INSERTED. DURING THE REVISION, HOWEVER, IT WAS NOTED THAT THE GLENOID PE INSERT OF THE UNIVERSAL GLENOID LOOKED UNUSUAL. THE GLENOID INSERT WAS PROBABLY SUBJECTED TO DECENTRALIZED LOADING DUE TO THE POOR POSITIONING OF THE HUMERAL COMPONENT AND THEREFORE SHOWED UNUSUAL WEAR PATTERNS. HOWEVER, IT WAS ALSO NOTICEABLE THAT A KIND OF LAYER HAD COME LOOSE ON THE GLENOID INSERT ("DELAMINATION"). THE AFFECTED DEVICES AR-9121-02, AR-9347-18, AR-9300-47 AND AR-9301-01 WERE REMOVED AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 22211945 ↗
• 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. THE SHOULDER PROSTHESIS WAS CHANGED TO AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16838757 ↗
• 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 16838696 ↗
• InjuryApr 28, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO AN ABRASION OF THE INLAY. THE SHOULDER PROSTHESIS WAS CHANGED TO AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16838632 ↗
• 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 16838371 ↗
• MalfunctionMar 21, 2022Degraded; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A PROGRESSIVE POLYETHYLENE DEGRADATION WITH METALLOSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 13839577 ↗
• 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 13053843 ↗
• InjuryAug 7, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN AR-9121-02 DEVICE BECAME DISLODGED APPROXIMATELY SEVEN (7) MONTHS POST-OP. THE ORIGINAL PROCEDURE WAS AN APEX WITH UG, WHICH TOOK PLACE (B)(6) 2019. EARLY (B)(6) THE PATIENT REPORTED THE A POP WAS FELT AFTER SLEEPING ON THE SHOULDER WRONG AND STRETCHING HIS ARM OUT. X-RAYS WERE TAKEN TO DETERMINE THE AR-9121-02 HAD BECOME DISLODGED. A REVISION PROCEDURE WAS PERFORMED (B)(6) 2020 BY THE SAME SURGEON AT THE SAME FACILITY. THE AR-9121-02, LOT 170139814, WAS EXPLANTED AND THE PATIENT WAS CONVERTED TO A REVERSE SHOULDER. THE EXPLANTED DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 10379188 ↗
• 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 9409853 ↗
• 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 9396458 ↗