Arthrex® AR-9560-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867296411), received between May 20, 2020 and Dec 1, 2025 — classified as 10 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A REVERS SHOULDER ARTHROPLASTY ON INSERTION, USING THE CANNULATED INSERTER, THE BASEPLATE DETACHED FROM THE POST AND THE POST REMAINED IN THE GLENOID VAULT. THE INITIAL IMPLANT ASSEMBLY WAS OBSERVED BY THE REP, AND SEEMED TO BE AS PER INSTRUCTIONS. BASEPLATE & POST SEEMED TO BE ALIGNED AND FULL COMPRESSION WAS ACHIEVED USING THE DEVICE. IT WAS SUCCESSFULLY REMOVED USING A 4MM HEX AND A NEW BASEPLATE & POST WERE ASSEMBLED AND INSERTED SUCCESSFULLY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681264 ↗
• MalfunctionJul 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 06/17/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-9560-24 ARTHREX® UNIVERS REVERS¿ MODULAR GLENOID SYSTEM MODULAS BASEPLATE 24 MM AND AN AR-9561-25S UNIVERS REVERS¿ MODULAR GLENOID SYSTEM CENTRAL SCREW CAME APART FROM EACH OTHER. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE THE TWO DEVICES MATE TOGETHER AS ALWAYS AND DURING IMPLANTATION THE SCREW COMPLETELY DISASSOCIATED FROM THE PLATE. ALL THE FRAGMENTS WERE RETRIEVED. AN THE CASE WAS COMPLETED USING ANOTHER AR-9560-24 ARTHREX® UNIVERS REVERS¿ MODULAR GLENOID SYSTEM MODULAS BASEPLATE 24 MM AND AN AR-9561-25S UNIVERS REVERS¿ MODULAR GLENOID SYSTEM CENTRAL SCREW. THIS DELAYED THE PROCEDURE 3-4 MINUTES, WHERE MINIMAL ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485151 ↗
• MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9560-24 BASEPLATE 24 MM AND AN AR-9561-30S CENTRAL SCREW 30 MM WERE BEING IMPLANTED WHEN THE SCREW DISASSOCIATED FROM THE BASEPLATE. BEFORE PRESSING THE TWO IMPLANTS TOGETHER IT WAS CONFIRMED THAT THE SCREW WAS CORRECTLY SEATED ONTO THE BASEPLATE, AND THE COMPONENTS WERE PRESSED TOGETHER PROPERLY. DURING IMPLANTATION, THEY ATTEMPTED AN ADJUSTMENT, AND WHEN THE BASEPLATE CAME OUT, THE SCREW STAYED IN. BOTH COMPONENTS APPEARED STRIPPED. THE CASE WAS COMPLETED, AND NO FURTHER DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 06/27/2025: DURING THE PROCEDURE, THE SCREW AND BASEPLATE APPEARED TO DISASSOCIATE WHILE BEING IMPLANTED. BOTH COMPONENTS WERE SUCCESSFULLY EXTRACTED USING THE APPROPRIATE REMOVAL INSTRUMENTS, AND THE CASE PROCEEDED WITHOUT COMPLICATION. THE BASEPLATE WAS REPLACED WITH PART NUMBER AR-9560-24, AND THE SCREW WAS REPLACED WITH PART NUMBER AR-9561-30S. THERE WAS A MINIMAL CASE DELAY AND A LIMITED TIME REQUIRED TO REMOVE AND REPLACE THE COMPONENTS. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455726 ↗
• MalfunctionApr 2, 2025Defective Device; Defective Device

  ON 3/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9560-24 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM BASEPLATE WOULD NOT ENGAGE WITH AN AR-9561-25S UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL SCREW. THE SURGEON ENSURED HAVING PAST THE MINIMUM LINE AND EVERYTHING APPEARED AS IT SHOULD, BUT THE IMPLANTS DID NOT MATE PROPERLY. THE CASE WAS COMPLETED WITH A NEW IMPLANT. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 3/18/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751157 ↗
• MalfunctionFeb 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INVERSE SHOULDER PROSTHESIS SURGERY WITH MGS THE THREAD OF THE GLENOSPHERE SCREW DID NOT HOLD INSIDE THE BASE PLATE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458697 ↗
• InjuryOct 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 9/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-24 UNIVERS REVERS MODULAR GLENOID BASEPLATE AND AN AR-9561-20P MODULAR GLENOID CENTRAL POST WERE LOOSE AND FLOATING IN THE PATIENT'S JOINT. THE IMPLANTS WERE FLIPPED LATERALLY. THIS WAS DISCOVERED ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20449726 ↗
• MalfunctionMay 23, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9561-20S UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL SCREW DID NOT ACQUIRE THE PURCHASE ON AN AR-9560-24 UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE. THEY FUSED TOGETHER WHEN ATTEMPTING TO REMOVE THE CENTRAL SCREW, SO THE SURGEON HAS TO REMOVE THE BASEPLATE AS WELL. THE CASE WAS COMPLETED WITH A DIFFERENT BASEPLATE AND CENTRAL SCREWS. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/29/2024: THE PROCEDURE WAS COMPLETED USING A NEW AR-9560-24 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE AND AN AR-9561-30S UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL SCREW. THE CASE WAS DELAYED AS THE SURGEON HAD TO REMOVE THE FAULTY IMPLANTS AND INSERT THE NEW ONES.

  Patient problems: Insufficient Information

  MAUDE report 19380376 ↗
• MalfunctionMay 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 5/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-24 UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE, AND AN AR-9561-30S UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL SCREW, DISSOCIATED DURING IMPLANTATION. ON THE ASSEMBLY PRESS, PROPER HEX ALIGNMENT BETWEEN BASEPLATE AND CENTRAL SCREW WAS FOUND VIA GENTLE ROTATION OF SCREW UNTIL IT FELL FLUSH TO THE BACK OF THE BASEPLATE. THE BASEPLATE WAS ALIGNED ON THE CORRECT SMALL/LARGE PEGS. THE PRESS WAS CRANKED DOWN/PRESSURED THE MORSE TAPE TOGETHER UNTIL THE LASER LINE WAS BETWEEN MIN/MAX. IMPLANT WAS THREADED ONTO INSERTER AND PLACED INTO GLENOID. DURING ROTATION OF SCREWING THE IMPLANT INTO GLENOID, THE BASEPLATE POPPED OFF THE CENTRAL SCREW, LEAVING THE SCREW IN THE GLENOID. IT WAS REMOVED CLEANLY WITH THE HEX DRIVER FROM THE MGS 2 TRAY. ADDITIONAL INFORMATION RECEIVED ON 5/23/2022: CASE WAS COMPLETED USING A NEW BASEPLATE AND CENTRAL SCREW, NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19338393 ↗
• MalfunctionApr 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 5/5/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9561-25S UNIVERS REVERS CENTRAL SCREW AND AN AR-9560-24 UNIVERS REVERS BASEPLATE DISASSOCIATED WHEN SURGEON ATTEMPTED TO INSERT IT INTO THE PATIENT'S GLENOID. SURGEON ASSEMBLED THEM BUT FELL APART AGAIN DURING INSERTION. ANOTHER BASEPLATE AND CENTRAL SCREW WERE OPENED, AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 5/6/2022: THIS WAS DISCOVERED DURING A RTSA PROCEDURE ON (B)(6) 2022. NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 19073111 ↗
• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 36 CAME LOOSE FROM THE SUTURECUP AND COULD NOT BE SEPARATED. THE TRIAL CA ADAPTER WAS PLACED IN THE SUTURECUP AND THE TRIAL CA HEAD WAS PLACED. AN X-RAY WAS TAKEN, AND IT WAS DETERMINED THAT THE CA HEAD WAS THE APPROPRIATE SIZE. THE TRIALS WERE REMOVED. THE STEM/CUP IMPACTOR HANDLE WAS THREADED INTO THE CA ADAPTER. THE TAB OF THE CA ADAPTER WAS ALIGNED WITH THE LATERAL SLOT OF THE SUTURECUP. THE IMPLANT WAS IMPACTED INTO THE SUTURECUP. THE CA HEAD WAS IMPACTED WITH THE GLENOSPHERE IMPACTOR MAKING SURE THE HOOD OF THE HEAD WAS LATERAL. THE CA ADAPTER CAME LOOSE FROM SUTURECUP. THE SURGEON ASKED FOR A NEW CA ADAPTER AND A CA HEAD AS THEY COULD NOT BE SEPARATED. A SECOND AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER WAS PLACED ON THE IMPACTOR HANDLE AND WAS IMPACTED INTO THE SUTURECUP. THE GLENOSPHERE IMPACTOR WAS USED AS WELL TO SEAT THE ADAPTER INTO THE SUTURECUP BUT WITH LITTLE EFFORT, THE CA ADAPTER COULD BE PULLED FROM THE SUTURECUP. THE SURGEON WAS ABLE TO SEPARATE THE FIRST SET OF IMPLANTS AND TRIED AGAIN TO IMPACT THE CA ADAPTER INTO THE SUTUR

  Patient problems: Failure of Implant

  MAUDE report 19063266 ↗
• MalfunctionApr 5, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A UNIVERS REVERS MGS SURGERY SCREW WHICH IS PRESSED INTO THE PLATE DID NOT HOLD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053658 ↗
• MalfunctionApr 5, 2024Defective Device; Defective Device

  ON 12/13/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-4 BASEPLATE AND AN AR-9561-30S CENTRAL SCREW WERE NOT IMPLANTED CORRECTLY BECAUSE THE MORSE TAPER FELL APART. THIS WAS DISCOVERED DURING A PROCEDURE. SURGEON COMPLETED CASE SUCCESSFULLY WITHOUT FURTHER ISSUE BY USING A NEW BASEPLATE AND CENTRAL SCREW. AFTER RECEIVING ADDITIONAL INFORMATION ON 12/14/2021, SALES REPRESENTATIVE HAS CONFIRMED THAT CASE WAS COMPLETED USING AN AR-9560-24 FROM LOT NUMBER 12732669 AND AN AR-9561-30S FROM LOT NUMBER 9549. NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19052767 ↗
• MalfunctionApr 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN UNIVERS REVERS MGS SURGERY THE CENTRAL SCREW HAS LOOSENED DURING INSERTION OF THE BASE PLATE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020527 ↗
• MalfunctionMar 29, 2024Defective Device; Defective Device

  IT WAS REPORTED ON 08/05/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9561-30S AND AR-9560-24 SCREW AND BASEPLATE WOULD NOT FIT TOGETHER AND WERE STRIPPED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008527 ↗
• InjuryJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9501-06P HUMERAL STEM, AN AR-9502F-36CPC SUTURE CUP, AN AR-9503S-03 HUMERAL INSERT, AN AR-9564-2436-LAT GLENOSPHERE, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, (2)AR-9563-28 PERIPHERAL SCREW, AND (2) AR-9563-20 PERIPHERAL SCREW, WERE EXPLANTED DURING A REVISION SHOULDER ARTHROPLASTY SURGERY ON (B)(6) 2023. ON (B)(6) 2022, THE PATIENT UNDERWENT ORIGINAL SURGERY. THEN IN (B)(6) OF 2023, THE PATIENT STARTED TO EXPERIENCE PAIN. RADIOGRAPHS APPEARED TO SHOW SOME RADIOLUCENT LINES AROUND THE BASEPLATE. THE PATIENT DID NOT REPORT ANY FALLS OR NOTABLE EVENTS. THE INFECTION TYPE HAS NOT BEEN CONFIRMED. DURING THE REVISION SURGERY, AN AR-9150-21 CA HUMERAL HEAD AND AN AR-9100-05P MONOBLOCK STEM WERE IMPLANTED AS FUNCTIONAL ANTIBIOTIC SPACERS. BOTH PROCEDURES WERE PERFORMED BY THE SAME SURGEON BUT AT DIFFERENT FACILITIES.

  Patient problems: Unspecified Infection

  MAUDE report 17111890 ↗
• MalfunctionApr 21, 2023Break; Break

  ON 3/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9560-24 24MM BASEPLATE, MODULAR HAD AN ISSUE. DURING A REVERSE SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023.WHEN THE SURGEON TRIED TO USE THE BASEPLATE, THE SCREWS SEPARATED/BROKE OFF FROM THE BASEPLATE INSIDE THE PATIENT, AND THE IMPLANT COULD NOT BE USED. THE SCREWS WERE SOLVABLE. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT, AND A NEW BASEPLATE WITH LOT NUMBER 14996909 WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16785336 ↗
• InjuryJun 2, 2022Break; Unstable; Naturally Worn

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A RIGHT SHOULDER RTSA ON (B)(6) 2019. PATIENT UNDERWENT A REVISION SURGERY DUE TO CHRONIC INSTABILITY OF THE GLENOID, WHICH APPEARED TO BE WORN OUT. HOWEVER, SALES REPRESENTATIVE COULD NOT CONFIRM IF ANY OF THE ARTHREX IMPLANTED DEVICES HAD BROKEN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THE ORIGINAL PROCEDURE OCCURRED ON 5/24/52019 AND PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON. ON (B)(6) 2019, AN AR-9501-05P HUMERAL STEM, AN AR-9502F-36CPC SUTURE CUP, AN AR-9503-3633-3 HUMERAL INSERTER, (2) AR-9560-24 BASEPLATE, FROM DIFFERENT LOT NUMBERS, AN AR-9561-20S CENTRAL SCREW, AN AR-9561-25S CENTRAL SCREW, (3) AR-9563-16 PERIPHERAL LOCKING SCREWS, ONE BEING FROM A DIFFERENT LOT NUMBER, AND AND AR-9564-2433 GLENOSPHERE WERE IMPLANTED. SALES REPRESENTATIVE CANNOT CONFIRM WHICH DEVICES WERE EXPLANTED DURING REVISION SURGERY ON (B)(6) 2020. HOWEVER, DURING REVISION SURGERY ON 7/17/2020, AN AR-9503-3633-3C HUMERAL INSERTER, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AND AR-9563-16 PERIPHERAL LOCKING SCREW

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14573473 ↗
• InjuryJun 2, 2022Break; Unstable; Naturally Worn

  ON 5/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A RIGHT SHOULDER RTSA ON (B)(6) 2019. PATIENT UNDERWENT A REVISION SURGERY DUE TO CHRONIC INSTABILITY OF THE GLENOID, WHICH APPEARED TO BE WORN OUT. HOWEVER, SALES REPRESENTATIVE COULD NOT CONFIRM IF ANY OF THE ARTHREX IMPLANTED DEVICES HAD BROKEN. ADDITIONAL INFORMATION RECEIVED ON 5/12/2022: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2019 AND PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON. ON (B)(6) 2019, AN AR-9501-05P HUMERAL STEM, AN AR-9502F-36CPC SUTURE CUP, AN AR-9503-3633-3 HUMERAL INSERTER, (2) AR-9560-24 BASEPLATE, FROM DIFFERENT LOT NUMBERS, AN AR-9561-20S CENTRAL SCREW, AN AR-9561-25S CENTRAL SCREW, (3) AR-9563-16 PERIPHERAL LOCKING SCREWS, ONE BEING FROM A DIFFERENT LOT NUMBER, AND AND AR-9564-2433 GLENOSPHERE WERE IMPLANTED. SALES REPRESENTATIVE CANNOT CONFIRM WHICH DEVICES WERE EXPLANTED DURING REVISION SURGERY ON (B)(6) 2020. HOWEVER, DURING REVISION SURGERY ON (B)(6) 2020, AN AR-9503-3633-3C HUMERAL INSERTER, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AND AR-9563-16 PERIPHERAL LOCKING SCREW,

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14573302 ↗
• InjuryJun 8, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE POST-OP IMAGES SHOW EITHER THE AR-9560-24 GLENOSPHERE NOT FULLY ENGAGED ON THE AR-9564-2433-LAT BASEPLATE (EVEN THOUGH THE LOCKING SCREW FULLY ENGAGED TO 4NM), OR THE BASEPLATE IS A +4 LATERALIZED BASEPLATE AND WAS MISLABELED. SEE SOURCE DATA AND X-RAY IMAGE ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 5/17/2021: THE REP REPORTED THE THERE WERE NO ISSUES/DEVIATIONS DURING THE PROCEDURE WHEN ATTEMPTING TO ENGAGE THE GLENOSPHERE AND BASEPLATE AND EVERYTHING ENGAGED AS IT NORMALLY WOULD. THE ISSUE WAS NOTICED ON THE SAME DAY THE PRODUCTS WERE IMPLANTED WHILE TAKING POST-OP IMAGES. THE REP REPORTED THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED ON 5/17/2021: THE REP REPORTED ONLY THE GLENOSPHERE SCREW WAS EXPLANTED. THE SURGEON RE-IMPACTED THE GLENOSPHERE TO ENSURE TAPPER SEEDING, THEN REPLACED THE GLENOSPHERE SCREW. THE ONLY AVAILABLE X-RAY COPIES ARE PRE-REVISION. THERE ARE NO POST REVISION IMAGES AVAILABLE. PENDING CONFIRMATION ON PART/LOT NUMBER OF EXPLANTED GLENOSPHERE SCREW.

  Patient problems: Failure of Implant

  MAUDE report 11956394 ↗
• MalfunctionJun 1, 2021Break; Device Dislodged or Dislocated

  IT WAS REPORTED, DURING A REVERSE TOTAL SHOULDER AS THE SURGEON WAS INSERTING THE AR-9560-24, PLATE, THE AR-9561-20S SCREW CAME OFF FROM THE PLATE, THE SCREW WAS IN THE PATIENTS GLENOID AND THE PLATE BECAME DISENGAGED. THE BROKEN PLATE AND SCREW WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED BY OPENED A SECOND AR-9560-24 AND AR-9561-20S, NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11912218 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVERSE SHOULDER CASE DONE IN (B)(6) 2020. DUE TO INFECTIONS, ALL THE DEVICES WERE REMOVED ON (B)(4) 2021. AN ANTIBIOTIC SPACER WAS PLACED AT THE SITE; THERE MAY BE A SHOULDER REVISION DONE IN THE FUTURE. REMOVED AR-9501-05P, AR-9502F-36RCPC, AR-9564-2433-LAT, AR-9503-3633-3C, AR-9560-24, AR-9561-30S.

  Patient problems: Unspecified Infection

  MAUDE report 11872002 ↗
• InjuryMar 15, 2021Loose or Intermittent Connection

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO THE LOOSENING OF AN ARTHREX PROSTHETIC JOINT. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2020. THE COMPLICATION WAS REPORTED ON (B)(6) 2020; INDICATING LOOSENING OF PROSTHETIC JOINT AND A REVISION REQUIRED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021. THE FOLLOWING ARTHREX PRODUCT WAS EXPLANTED DURING THE REVISION SURGERY; AR-9560-24 (LOT: 5655). AR-9561-20P (LOT: 7038). AR-9562-36NL (LOT: 2018005757). AR-9562-40NL (LOT: 2018001457). AR-9563-20 (LOT: 2019003063). AR-9564-2436-LAT (LOT: 19.03388). AR-9502F-36RCPC (LOT: 19.00394). AR-9503S-06 (LOT: 170052510). THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE REVISION SURGERY; AR-9502F-36RCPC (LOT: 20.01053). AR-9555-06 (LOT: 170143213). AR-9503S-06 (LOT: 20.01369).

  Patient problems: Failure of Implant

  MAUDE report 11485611 ↗
• InjuryOct 28, 2020Loose or Intermittent Connection

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A ISSUE POSSIBLY RELATED TO AN ARTHREX PRODUCT TOOK PLACE. UPON FURTHER INVESTIGATION THE FOLLOWING WAS DISCOVERED: A PATIENT HAD UNDERGONE A REVERSE TOTAL SHOULDER ARTHROPLASTY (B)(6) 2019. IT WAS DIAGNOSED VIA X-RAY AND CT SCAN (B)(6) 2020 THAT THE PATIENT WAS EXPERIENCING LOOSENING OF THE IMPLANT GLENOID SIDE. A REVISION OF GLENOID AND HUMERAL COMPONENTS WITH ALLOGRAFT SURGERY WAS PERFORMED (B)(6) 2020 DURING WHICH TIME THE FOLLOWING ORIGINAL ARTHREX IMPLANTS WERE EXPLANTED: ARTHREX UNIVERS REVERS MGS PERIPHERAL SCREW NL 4.5X24 MM; LOT # 170182004; CATALOG # AR-9562-24NL, ARTHREX UNIVERS REVERS MGS PERIPHERAL SCREW 4.5X32 MM; LOT # 2018001455; CATALOG # AR-9562-32NL; QTY 2, ARTHREX CENTRAL SCREW MODULAR 30 MM; LOT # 5652; CATALOG # AR-9561-30S, ARTHREX GLENOSPHERE 39 +4 LAT/24; LOT # 18.00656; CATALOG # AR-9564-2439-LAT, ARTHREX CUP UNIVERS REVS SUTURE 39MM NTRL +2 LEFT; LOT # 170074105; CATALOG # AR-9502F-39LCPC, ARTHREX BASEPLATE 24 M MODULAR; LOT # 5362; CATALOG # AR-9560-24. AFTER REMOVAL OF THE ABOVE DEVICES THE SURGEON PERFORMED A CONVERSION TO HEMIARTHROPLASTY WITH GLENOID BONE GRAFT.

  Patient problems: Failure of Implant

  MAUDE report 10747440 ↗
• InjuryMay 20, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL REVERSE SHOULDER PROCEDURE WITH MODIFIED GLENOID SYSTEM IN (B)(6) 2019. THE PATIENT HAD RECENTLY UNDERGONE A REVISION PROCEDURE ON (B)(6) 2020 DUE TO PAIN AND CONSTRUCT DISLOCATION. AT THE (B)(6) REVISION, THE HUMERAL INSERT WAS EXPLANTED AND A SPACER AND NEW INSERT WERE IMPLANTED. THE (B)(6) 2020 REVISION WAS REPORTED UNDER CASE (B)(4). ON (B)(6) 2020, THE PATIENT HAD A THIRD PROCEDURE DUE TO NEUROPATHY; THE FOLLOWING DEVICES WERE ALL EXPLANTED: IMPLANTS: AR-9503S-03C (LOT 19.00210), AR-9555-06 (LOT 16.01037), AR-9564-2436-LAT (LOT 19.00689) AND AR-9560-24 (LOT 02191932) AND 4 SCREWS: AR-9563-16, AR-9563-28 (QTY2) AND AR-9563-20 TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING DEVICES: AR-9502-36ARCA (LOT 18.00755) AND AR-9550-19RCA (LOT 10071328).

  Patient problems: Neuropathy; Pain

  MAUDE report 10074349 ↗