Arthrex® AR-9504M-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867061378), received between Mar 29, 2018 and Aug 6, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER A PATIENT WAS TREATED IN 2013 WITH AN UNIVERS REVERS WITH A 36 SUTURE CUP AND A UNIVERSAL GLENOID (39 GLENOSPHERE). THE PATIENT HAD A GUT SURGERY RECENTLY AND STARTED FEELING UNWELL AND HAVING SHOULDER PAIN. THE PATIENT VISITED THE SURGEON WHOM THEN DISCOVERED THAT THERE WAS AN INFECTION IN THE RIGHT SHOULDER AND SAW COMPONENT LOOSENING AND WEAR IN THE CT SCAN. AT FIRST THE SURGEON REMOVED THE GLENOSPHERE AND SUTURE CUP WHICH WERE ALREADY LOOSE ON THE (B)(6), 2025 AND TOOK SAMPLES TO DETERMINE THE SOURCE OF THE INFECTION. THE SURGEON THEN REPORTED ON THE (B)(6) THAT EVERYTHING HAD TO BE REMOVED OUT DUE TO THE PATHOGEN BEING A MORE SERIOUS. UPON REMOVAL, THE SURGEON SAW A SEVERE METALLOSIS AND TISSUE CHANGES AROUND THE IMPLANT AND THE IMPLANT ITSELF WAS COMPLETELY WORN. IT WAS FURTHER REPORTED THAT THERE WAS NO REPORT OF A PATIENT ACCIDENT SUCH AS A FALL OR OTHER INJURY THAT MAY HAVE CAUSED THIS. ***UPDATE DW (B)(6) 2025 FURTHER CLARIFICATION WAS PROVIDED THAT THERE WERE 2 REVISIONS, THE FIRST ONE WAS PERFORMED ON THE (B)(6) AND A SECOND ONE ON (B)(6). THE SECOND REVISION WHICH WAS PERFORMED ON THE (B)(6) 2025 IS HANDLED IN CASE (B)(4). THE FOLLOWING DEVIC

  Patient problems: Metal Related Pathology

  MAUDE report 22730753 ↗
• 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 THE (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 18429336 ↗
• InjuryMay 24, 2021Mechanical Problem; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVERSE TOTAL SHOULDER WAS PERFORMED ON (B)(6), 2021. THE INDEX PROCEDURE WAS WITHOUT COMPLICATIONS AND THE AR-9504M-04 GLENOSPHERE WAS IMPLANTED UTILIZING THE INDICATED TECHNIQUES AND CHECK OF MORSE TAPER ENGAGEMENT. IT WAS DISCOVERED DURING A ROUTINE VISIT VIA A FOLLOW-UP X-RAY THAT THE GLENOSPHERE DID NOT APPEAR TO BE SEATED PROPERLY. ON (B)(6) 2021 THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR A REVISION SURGERY. DURING THE REVISION SURGERY, THE GLENOSPHERE WAS FOUND TO NO LONGER BE ENGAGED. THE SURGEON FELT THAT THE ORIGINAL GLENOSPHERE MAY HAVE WEDGED INTO THE BASEPLATE ON THE ORIGINAL OPERATION. THE DECISION WAS MADE TO IMPLANT A NEW GLENOSPHERE OF THE SAME SIZE. AFTER IMPACTION, THE MORSE TAPER WAS AGAIN CHECKED IN MULTIPLE PLAINS AND FELT TO BE ENGAGED. A NEW SUTURE CUP WAS THEN PLACED ALONG WITH A NEW POLY INSERT AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM WITHOUT COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 11872455 ↗
• InjuryAug 6, 2019Detachment of Device or Device Component

  IT WAS REPORTED AFTER HAVING A PRIMARY REVERSE SHOULDER ARTHROPLASTY PROCEDURE ON 30072843132019, THE PATIENT'S GLENOSPHERE DISASSOCIATED POST-OP. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE: AR-95075 // LOT: 10271054; AR-9165-20NL // LOT: 10260410; AR-9210-02 // LOT: 18.01648; AR-9145-36 // LOT: 18.00922; AR-9145-30 // LOT: 18.01719; AR-9504M-04 // LOT: 18.00869; AR-9501-06P // LOT: 18.01549; AR-9502F-39CPC // LOT: 18.00489; AR-9503M-03C // LOT: 18.00111. THE REP STATED IT IS UNKNOWN IF THE PATIENT WAS EXPERIENCING ANY PAIN OR DISCOMFORT. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. THE REP STATED COPIES OF X-RAY'S ARE NOT AVAILABLE, NOR WERE ANY PICTURES TAKEN. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE FOLLOWING ARTHREX PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9504M-04 // LOT: 18.00869; AR-9502F-39CPC // LOT: 18.00489; AR-9503M-03C // LOT: 18.00111. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE REVISION PROCEDURE: AR-9504M-04 // LOT: 18.01612; AR-9502F-39CPC // LOT: 18.01655; AR-9505-06 // LOT: 18.00982; AR-9503M-03C // LOT: 18.01758/ ADDITIONAL INFORMATION

  Patient problems: Failure of Implant

  MAUDE report 8863837 ↗
• InjuryMar 1, 2019Material Disintegration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERS TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2018 WHERE A UNIVERS GLENOID, AR-9504M-04 AND A HUMERAL INSERT, AR-9503M-06, WERE IMPLANTED. POST-OP, THE GLENOSPHERE DISASSOCIATED FROM THE BASEPLATE AND WAS REVISED WITH A NEW GLENOSPHERE. ADDITIONAL DETAILS PROVIDED (B)(6) 2019: THE REVISION TOOK PLACE ON (B)(6) 2019. THE PATIENT DID NOT REPORT ANY TRAUMA TO THE SURGEON HOWEVER THE SURGEON STATED THAT THE DISASSOCIATION OCCURRED DURING PHYSICAL THERAPY.

  Patient problems: No Information

  MAUDE report 8381724 ↗
• InjuryApr 11, 2018Malposition of Device

  IT WAS REPORTED THAT THE PATIENT HAD A FALL AFTER SURGERY AND THE IMPLANT BACKED OUT OF THE PATIENT'S SHOULDER. A REVISION HAS BEEN SCHEDULED BUT THE DATE HAS NOT YET BEEN CONFIRMED. PLEASE SEE ATTACHED X-RAYS. NO FURTHER DETAILS, ADDITIONAL INFORMATION HAS BEEN REQUESTED. FOLLOW-UP INVESTIGATION: IMPLANTS THAT WERE REMOVED WERE AR-9504M-04, LOT: 170036414 (LINE 225343) AND AR-9503M-03, LOT: 170041310 (LINE: 227698) DATE OF ORIGINAL SURGERY WAS (B)(6) 2018. DATE OF REVISION WAS (B)(6) 2018. THE SURGEON WANTED TO KEEP IMPLANTS. THE PATIENT FELL 6 WEEKS POST-OP.

  Patient problems: Fall

  MAUDE report 7422076 ↗
• InjuryMar 29, 2018Device Operates Differently Than Expected

  THIS IS AN AUTOMATED COMMUNICATION RECEIVED DIRECTLY FROM A PATIENT IN THE SURGICAL OUTCOME SYSTEM STUDY. THE SURGEON ALSO RECEIVES THIS REPORT AND IS INSTRUCTED TO NOTIFY PRODUCT SURVEILLANCE OF ANY ARTHREX PRODUCT INVOLVEMENT. AN EMAIL HAS BEEN SENT TO THE SURGEON REQUESTING FURTHER DETAILS IF PRODUCT RELATED. FOLLOW-UP INVESTIGATION: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE TSA WITH GLENOID GRAFT PROCEDURE ON (B)(6) 2017. THE PATIENT HAD AN EARLY GLENOID AND GRAFT FAILURE AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE SURGEON PERFORMED A SIMPLE REVISION WITH REMOVAL OF THE FRAGMENTED GRAFT AND MEDIALIZATION OF THE BASEPLATE. THE SURGEON STATED THAT WITH THE PATIENT'S MEDIALIZED BASE PLATE HE WILL DEVELOP SOME NOTCHING AND HIS MOTION WILL NOT BE AS GOOD AS IT COULD HAVE BEEN.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7380855 ↗