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

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867061408), received between Nov 1, 2016 and Nov 20, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2024Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DEVICE DISLOCATED AFTER THE SURGERY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THE SURGEON CHANGED THE GLENOSPHERE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 20733694 ↗
• 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 THE (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 10746402 ↗
• InjuryOct 23, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A REVERSE TOTAL SHOULDER ARTHROPLASTY, (B)(6) 2018. THE PATIENT WAS EXPERIENCING PAIN WITH SHOULDER PAIN FROM IMPINGEMENT. CT/MRI WERE PERFORMED BY THE ORIGINAL SURGEON AND A DECISION WAS MADE TO PERFORM A REVISION PROCEDURE, (B)(6) 2020. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE AR-9503S-03 (LOT170137113) AND AR-9504S-04 (LOT 170147116). TO COMPLETE THE PROCEDURE THE SURGEON SWAPPED AN INFERIOR GLENOSPHERE AND PUT IN A NEW POLY THE SAME SIZE. THE SAME SURGEON PERFORMED BOTH PROCEDURES. THE SAME ARTHREX SALES REPRESENTATIVE WAS PRESENT FOR BOTH PROCEDURES. PER FACILITY THE DEVICES WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 10730350 ↗
• InjurySep 2, 2020Break; Corroded; Unstable; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL REVISION SURGERY ON (B)(6) 2018 DURING WHICH THE FOLLOWING DEVICES WERE IMPLANTED: AR-9120-01 (LOT 170115215), AR-9145-36 (LOT 170037012), AR-9145-30 (LOT 170057712), AR-9504S-04 (LOT 170091414), AR-9555-09 (LOT 2501367202), AR-9503S-03C (LOT 2501374603), AR-9165-25 (LOT 2501357504). THE (B)(6) 2018 PROCEDURE WAS A REVISION OF ARTHREX PRODUCTS BECAUSE THE PATIENT HAD GLENOID INSTABILITY DUE TO BASEPLATE PLACEMENT ON THE PRIMARY. IT IS UNKNOWN IF THE 2018 REVISION WAS EVER REPORTED TO ARTHREX AS NO DETAILS FROM THE ORIGINAL SURGERY ARE KNOWN TO SEARCH/MATCH PART NUMBERS. THE IMPLANTS PUT IN ON (B)(6) 2018 WERE DONE SO IN A COMPROMISED GLENOID WITH POOR BONE QUALITY. THE PERIPHERAL SCREWS BROKE AND LED TO BASEPLATE FAILURE. THE GLENOSPHERE REMAINED ENGAGED IN THE BASEPLATE. THERE WAS SIGNIFICANT CORROSION OF THE HUMERAL POLY INSERT. THE GLENOID COMPONENTS FAILED NEARLY TWO YEARS AGO BUT THE PATIENT WAITED UNTIL (B)(6) 2020 TO HAVE A REVISION SURGERY. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON ATTRIBUTED THE FAILURE TO PUTTING THE BASEPLATE ON HER ORIGINAL REVERSE PROCEDURE TOO SUPERIOR ON THE FACE OF THE GLENOID WITH S

  Patient problems: No Code Available

  MAUDE report 10482786 ↗
• InjuryJun 16, 2020Positioning Problem; Appropriate Device Problem Term/Code Not Available

  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 10158194 ↗
• InjuryApr 29, 2020Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A SHOULDER REVISION SURGERY WAS NEEDED AS THE IMPLANT BECAME LOOSE. THE REVISION SURGERY WAS FINISHED SUCCESSFULLY. NO FURTHER INFORMATION PROVIDED. UPDATED INFORMATION OBTAINED 20-APR-2020: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020 AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE REVISION SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.

  Patient problems: No Code Available

  MAUDE report 10010714 ↗
• InjuryApr 22, 2020Break

  ***FOLLOW-UP UPDATE ON 29-APR-2020 : FURTHER INFORMATION WAS PROVIDED THAT THE THE PATIENT WAS ELDERLY AND THE BONE QUALITY WAS NOT IN TOP CONDITION BUT ALSO NOT TOO BAD. THE DAMAGE TO THE IMPLANTS OCCURRED (AS THE PATIENT CLAIMS) WHEN PUTTING ON TROUSERS, THIS NECESSITATED THE REVISION, THEY DID NOT BREAK ON REMOVAL, THEY WERE ALREADY BROKEN FROM WHATEVER TRAUMA THEY SUFFERED. IT WAS FURTHER REPORTED THAT IT IS VERY UNLIKELY THAT JUST PUTTING ON TROUSERS CAUSED BOTH SCREWS TO BREAK.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9985419 ↗
• InjuryFeb 3, 2020Device Slipped

  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 9659049 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROSTHESES FAILED ABOUT 2,5 MONTH AFTER SURGERY. INITIAL SURGERY WAS SUCCESSFULLY COMPLETED ON (B)(6) 2019 AND PATIENT WAS RELEASED TO REHAB. ABOUT 2.5 MONTH AFTER SURGERY, THE GLENOSPHERE OF THE PROSTHESES BECAME LUXATED BECAUSE PATIENT WAS LEANING ON HIS ARMS. AS A CONSEQUENCE OF THE LUXATION, THE PROSTHESES HAD TO BE CHANGED IN A REVISION SURGERY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. NO FURTHER INFORMATION HAD BEEN MADE AVAILABLE. FURTHER QUESTIONS ASKED. UPDATE 17-OCT-2019: PATIENT IS AN ELDERLY LADY ((B)(6) YEARS). NO TRAUMA REPORTED. ACCORDING TO THE HOSPITAL SHE WAS COMPLIANT TO THE POST OP GUIDELINES. XRAYS HAVE BEEN TAKEN BUT NOT BEEN MADE AVAILABLE BY THE HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 9255030 ↗
• InjuryJul 31, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT HAD AN ARTHREX REVERS SYSTEM IMPLANTED ON (B)(6) 2018. IT WAS THEN DISCOVERED IN (B)(6) 2019 THAT THE IMPLANTED GLENOSPHERE (AR-9504S-04 / LOT: 170061914) HAD DISASSOCIATED. A REVISION REVERSE SHOULDER REPLACEMENT PROCEDURE TOOK PLACE ON (B)(6) 2019. DURING THE REVISION PROCEDURE, THE SURGEON ATTEMPTED TO PUT A NEW GLENOSPHERE ON THE ORIGINAL IMPLANTED BASEPLATE (AR-9120-01 / LOT: 170131615), BUT THE GLENOSPHERE WOULD NOT ENGAGE. THE SURGEON THEN REMOVED THE ORIGINAL BASEPLATE, AND PUT IN A NEW BASEPLATE AND THE SAME NEW GLENOSPHERE THAT WAS ATTEMPTED TO USE WITH THE DAMAGED BASEPLATE. THE COMPONENTS ENGAGED NORMALLY AND THE CASE WAS FINISHED. THE REP STATED THAT THE PATIENT HAS A HISTORY OF FALLS AND NON-COMPLIANCE. THE EXPLANTED GLENOSPHERE IS AVAILABLE FOR RETURN, BUT THE ORIGINAL BASEPLATE WAS DISCARDED BY THE FACILITY'S STERILE PROCESSING. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: THE REP CONFIRMED THE PRIMARY AND REVISION PROCEDURES WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE PATIENT HAD A FOLLOW-UP VISIT DUE TO COMPLAINING OF DISCOMFORT AFTER HAVING A REVERSE SHOULDER REPLACEMENT ON (B)(6) 2018. IT IS UNKNO

  Patient problems: Discomfort; Pain

  MAUDE report 8845614 ↗
• InjuryFeb 15, 2019Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT NEEDED TO HAVE A REVISION SURGERY ON A REVERSE TOTAL SHOULDER CASE. THE ORIGINAL CASE WAS (B)(6) 2019; THE REVISION WAS (B)(6) 2019. THE CASES WERE AT DIFFERENT FACILITIES WITH THE SAME DOCTOR. PATIENT IS A (B)(6) MAN; AT THE 2-WEEK FOLLOW UP, HE REPORTED HEARING A ¿NOISE¿ AT THE SITE. POST-OP COMPLIANCE IN UNKNOWN. AN X-RAY SHOWED THAT THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE AND THE INFERIOR SCREW HAD BACKED OUT. REMOVED FROM THE PATIENT WAS AR-9502F-36LCPC (170134308), AR-9504S-04 (18.00715), AR-9503S-03C (170062310), AR-9145-36 (18.00587). AR-9501-09C (18.00233), AR-9503S-03C (170062310). REMAINING IN THE PATIENT FROM THE ORIGINAL SURGERY WAS AR-9120-01, AR-9165-30NL, AR-9145-24. INSERTED INTO THE PATIENT AT THE REVISION WAS AR-9145-36, AR-9504S-04, AR-9501-09P, AR-9502F-36LCPC, AR-9555-06, AR-9555-09.

  Patient problems: No Information

  MAUDE report 8344187 ↗
• InjuryDec 4, 2018Device Dislodged or Dislocated

  IT WAS REPORTED BY THE SALES REP THAT THERE WAS A REVISION OF A RIGHT TOTAL SHOULDER CASE ON JULY 3, 2018. THE ORIGINAL DATE OF SURGERY WAS MAY 7, 2015. THE REVISION WAS DUE TO LIMITED RANGE OF MOTION AND PAIN. SEVEN DEVICES WERE REMOVED FROM THE PATIENT; THERE WAS PROXIMAL METALOSIS IN THE SHOULDER JOINT AND THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE. THE FOLLOWING ARTHREX REPLACEMENT DEVICES WERE IMPLANTED: AR-9504L-04, UNIVERS REVERSE GLENOSPHERE, LOT 170142415; AR-9502F-42CPC, UNIVERS REVERSE SUTURECUP, LOT 170117105; AND AR-9503L-06, UNIVERS REVERSE HUMERAL INSERT, LOT 170170513. ADDITIONAL INFORMATION OBTAINED 11/8/18: SALES REP HAS CONFIRMED THAT HIS ORIGINAL REPORT STATING 7 DEVICES WERE EXPLANTED WAS INCORRECT. ONLY THE FOLLOWING THREE DEVICES WERE EXPLANTED: AR-9503S-06 HUMERAL INSERT (LOT 2601221201), AR-9502-36CPC CUP (LOT 2501407907) AND AR-9504S-04 GLENOSPHERE (LOT 2501346003). ALL THREE DEVICES ARE BEING RETURNED TO ARTHREX FOR EVALUATION. ACCORDING TO THE MEDICAL RECORDS DURING THE REVISION SURGERY THE SURGEON DISCOVERED THE GLENOSPHERE TO BE COMPLETELY DISASSOCIATED FROM THE BASEPLATE. THE SURGEON ALSO NOTED A SIGNIFICANT AMOUNT OF WEAR ON THE INFERIOR AS

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

  MAUDE report 8129841 ↗
• InjurySep 19, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD REVERSE TOTAL SHOULDER ON (B)(6) 2016. THE PATIENT SUPPOSEDLY FELL IN (B)(6) WHICH DISLODGED THE BASEPLATE/GLENOSPHERE. REVISION SURGERY WAS COMPLETED ON (B)(6) 2017, CONVERTING TO HEMI. **ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017: THE DEVICES EXPLANTED DURING REVISION: AR-9120-01 LOT 160012712 (LINE 204892), AR-9165-15NL LOT 1444855 (LINE 205048), AR-9145-30 LOT 160024110 (LINE 205049), AR-9504S-04 LOT 160036711 (LINE 205050), AR-9503S-06 LOT 160010209 (LINE 205051), AR-9145-30 LOT 160009610 (LINE 205056). THE DEVICES IMPLANTED DURING THE REVISION WERE AR-9950-19RCA AND AR-9502-36ARCA. QUALITY OF BONE WAS REPORTED TO BE POOR. MALE, (B)(6)..

  Patient problems: No Code Available

  MAUDE report 6876253 ↗
• InjuryJun 2, 2017Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A UNIVERS REVERS SHOULDER PROCEDURE IN (B)(6) 2016. PER EVENT REPORTER THE PATIENT IS PRE-DIABETIC, HAS LONG TERM SYSTEMIC STEROID USE, AND VERY POOR TISSUE QUALITY. THE GLENOSPHERE BECAME DISASSOCIATED AND A REVISION SURGERY WAS DONE ON (B)(6) 2017. THE HUMERAL STEM AND BASEPLATE WERE INTACT AND SOLID. THE GLENOSPHERE, AR-9504S-04, LOT 150033709 ((B)(4)) AND HUMERAL CUP AR-9502-36CPC, LOT 2501495810 ((B)(4)) WERE EXTRACTED FROM THE PATIENT AND REPLACED WITH THE SAME SIZES AS USED PREVIOUSLY, HOWEVER, THE SURGEON REPLACED THE +3 UNIVERS REVERS HUMERAL INSERT AR-9503S-03, LOT 140115507 ((B)(4)) WITH A +6 CONSTRAINED LINER TO INCREASE STABILITY.

  Patient problems: No Code Available

  MAUDE report 6607838 ↗
• InjuryNov 1, 2016Migration or Expulsion of Device

  IT WAS REPORTED THAT THE 36 +4 LAT ARTHREX UNIVERS REVERS GLENOSPHERE, AR-9504S-04 ((B)(4)), WAS USED IN A RIGHT REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2016. DURING THE INITIAL REVERSE TSA, THERE WAS SOME QUESTION WHETHER OR NOT THE MORSE TAPER HAD ENGAGED. THE SURGEON VERIFIED THAT IT HAD ENGAGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A FEW DAYS LATER, THE SURGEON TOOK AN X-RAY OF THE SURGICAL SITE AND REVEALED THAT THE GLENOSPHERE HAD MIGRATED. DURING THE REVISION SURGERY, ON (B)(6) 2016 THERE WAS NO EVIDENCE OF GLENOID FRACTURE. IN ORDER FOR THE SURGEON TO DISTRACT THE SHOULDER AND COMPLETE THE REVISION IT WAS NECESSARY TO DAMAGE THE ORIGINAL POLY, AR-9503S-03 ((B)(4)) WHICH WAS REMOVED ALONG WITH THE GLENOSPHERE, AR-9504S-04. THE SURGEON ALSO DECIDED TO REMOVE THE SPACER, AR-9555-06 ((B)(4)), AND ULTIMATELY OPTED FOR ONLY THE POLY FOR THE REVISION. THIS CHANGE TOOK THE CUP BUILD UP FROM A +9 TO A +6 TOTAL. A NEW GLENOSPHERE AND POLY INSERT WERE OPENED AND USED TO COMPLETE THE REVISION SURGERY SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 6068913 ↗