Arthrex® AR-9563-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888867296824), received between May 20, 2020 and Apr 16, 2026 — classified as 20 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (10 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INVERSE SHOULDER PROSTHESIS SURGERY ON (B)(6) 2026 THE PATIENT HAS DEVELOPED AN INFECTION. ON (B)(6) 2026 ALL IMPLANTS WERE REMOVED AND THE AFFECTED AREAS WERE CLEANSED AND TREATED. A NEW PROSTHESIS WILL BE IMPLANTED IN 6-8 WEEKS.

  Patient problems: Unspecified Infection

  MAUDE report 24903218 ↗
• InjuryApr 16, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INVERSE SHOULDER PROSTHESIS SURGERY ON (B)(6) 2026 THE PATIENT HAS DEVELOPED AN INFECTION. ON (B)(6) 2026 ALL IMPLANTS WERE REMOVED AND THE AFFECTED AREAS WERE CLEANSED AND TREATED. A NEW PROSTHESIS WILL BE IMPLANTED IN 6-8 WEEKS.

  Patient problems: Unspecified Infection

  MAUDE report 24895153 ↗
• InjuryMar 4, 2026Break

  ON 28-JAN-2026, THE PATIENT REPORTED VIA EMAIL THAT, FOLLOWING A REVERSE TOTAL SHOULDER SURGERY, THEY EXPERIENCED INCREASING POSTOPERATIVE PAIN. X-RAYS REPORTEDLY SHOWED A BROKEN SCREW, AND A CT SCAN DEMONSTRATED A LOOSE IMPLANT. THE PATIENT IS NOW SCHEDULED FOR A CORRECTIVE SURGICAL PROCEDURE. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE FROM THE PATIENT'S RELATIVE ON (B)(6) 2026: THE PATIENT IS SCHEDULED TO UNDERGO A REVISION LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2026. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. OVER TIME, THE PATIENT DEVELOPED SIGNIFICANT LEFT SHOULDER PAIN. THE PATIENT¿S SPOUSE REPORTED PROGRESSIVE DISCOMFORT IN THE PATIENT¿S LEFT ARM. DIAGNOSTIC IMAGING WAS PERFORMED, INCLUDING AN X-RAY ON (B)(6) 2025, WHICH IDENTIFIED A FRACTURED SCREW, FOLLOWED BY A CT SCAN ON (B)(6) 2025 THAT DEMONSTRATED LOOSENING OF THE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE FROM THE PATIENT'S RELATIVE ON 10-FEB-2026: THE PATIENT'S SPOUSE REPORTED THAT THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, ALL COMPONENTS OF THE LEFT SHOULDER WERE R

  Patient problems: Discomfort; Pain

  MAUDE report 24512848 ↗
• InjuryNov 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 10/28/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 COMPONENTS COULD NOT BE SECURED DURING SURGERY. THE PROCEDURE WAS A REVISION REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2025. DURING THE OPERATION, THE ORIGINAL LINER WAS REMOVED FROM THE PATIENT. WHEN ATTEMPTING TO PLACE BOTH AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 INTO THE 39 SUTURE CUP, NEITHER ADAPTER WOULD SNAP INTO PLACE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/03/2025: THE PATIENT UNDERWENT A REVISION REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2025 FOLLOWING A FALL-RELATED INCIDENT. DURING THE PROCEDURE, ATTEMPTS TO IMPLANT TWO COMPONENTS, AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 AND AR-9556-22RCA UNIVERS REVERS CA HUMERAL HEAD 56/22, WERE UNSUCCESSFUL AS THEY COULD NOT BE SECURED. THIS ISSUE EXTENDED THE SURGICAL TIME BY APPROXIMATELY 30 MINUTES. AS PART OF THE REVISION, ALL IMPLANTS FROM THE ORIGINAL REVERSE SHOULDER ARTHROPLASTY PERFORMED IN (B)(6) 2023 WERE EXPLANTED. THE ORIGINAL SURGERY WAS PERFORMED AT THE SAME FACILITY BY THE SAME SURGEON AND HAD NO REPORTED INTRAOPERATIVE COMPLICATIONS. THE ARTHREX PRODUCTS IMPLANTED

  Patient problems: Insufficient Information

  MAUDE report 23586413 ↗
• MalfunctionJun 20, 2025Positioning Failure; Positioning Failure

  ON 05/29/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9563-20 PERIPHERIAL SCREW WOULD NOT FULLY SEAT. SURGEON USED APPROPRIATE LOCKING GUIDE AND DRILL FOR USING THE SCREW BUT COULDN¿T GET THE SCREW TO FULLY SEAT. HE BACKED THE SCREW OUT, RE DRILLED, AND THEN ATTEMPTED TO PUT THE SAME SCREW IN WITH THE SAME RESULT. HE THEN BACKED IT OUT AND NOTICED THAT THE SCREW APPEARED TO BE CROSS THREADED AND/OR DEFECTIVE. WE PUT IN A SHORTER 16 MM SCREW IN ITS PLACE, AND IT SAT FLUSH. NO HARM WAS DONE TO PATIENT AND THE ALTERNATIVE SOLUTION WAS SHORTER SCREW. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296688 ↗
• MalfunctionMay 13, 2025Defective Device; Defective Device

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9563-20 PERIPHERAL SCREW FAILED TO THREAD INTO THE BASEPLATE. A SECOND SCREW WAS ATTEMPTED AND SUCCESSFULLY THREADED, AND THE CASE WAS COMPLETED WITHOUT ISSUE. NO COMPONENTS BROKE IN THE PATIENT. THIS WAS DISCOVERED DURING A REVERSE SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009234 ↗
• InjuryMar 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 2/10/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A LOOSENING OF THE GLENOID SIDE IMPLANTS. AN X-RAY ON (B)(6) 2024, SHOWED LOSS OF FIXATION OF THE BASEPLATE. THE PATIENT WAS REVISED ON (B)(6) 2024. THE EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 3/7/2025: AR-9580-2410 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE, AN AR-9582-25 MODULAR POST FOR AUGMENTED MGS BASEPLATE, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, THREE AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9564-2433-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AND AN AR-9503XS-03 UNIVERS REVERS MODULAR GLENOID SYSTEM, HUMERAL INSERT WERE EXPLANTED DURING THE REVISION SURGERY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21700303 ↗
• InjuryMar 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 2/10/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A LOOSENING OF THE GLENOID SIDE IMPLANTS. AN X-RAY ON (B)(6) 2024, SHOWED LOSS OF FIXATION OF THE BASEPLATE. THE PATIENT WAS REVISED ON (B)(6) 2024. THE EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 3/7/2025: AR-9580-2410 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE, AN AR-9582-25 MODULAR POST FOR AUGMENTED MGS BASEPLATE, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, THREE AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9564-2433-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AND AN AR-9503XS-03 UNIVERS REVERS MODULAR GLENOID SYSTEM, HUMERAL INSERT WERE EXPLANTED DURING THE REVISION SURGERY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21700297 ↗
• InjuryMar 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 2/10/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A LOOSENING OF THE GLENOID SIDE IMPLANTS. AN X-RAY ON (B)(6)2024, SHOWED LOSS OF FIXATION OF THE BASEPLATE. THE PATIENT WAS REVISED ON (B)(6) 2024. THE EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 3/7/2025: AR-9580-2410 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE, AN AR-9582-25 MODULAR POST FOR AUGMENTED MGS BASEPLATE, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, THREE AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9564-2433-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AND AN AR-9503XS-03 UNIVERS REVERS MODULAR GLENOID SYSTEM, HUMERAL INSERT WERE EXPLANTED DURING THE REVISION SURGERY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21700215 ↗
• MalfunctionMar 20, 2025Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  ON (B)(6)2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW HAD AN ISSUE. DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6)2025, WHEN THE SURGEON WAS TRYING TO USE THE SCREW, THE SCREW WOULD NOT LOCK INTO AN AR-9580-2410S UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASE PLATE INSIDE THE PATIENT. THE SCREW WAS REMOVED FROM THE PATIENT IN ONE PIECE, NOTHING BROKE, AND THERE WAS NO HARM. ANOTHER AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW WITH A DIFFERENT UNKNOWN LOT NUMBER WAS SCREWED INTO THE SAME AR-9580-2410S UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASE PLATE INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO COMPLAINT ALLEGATION AGAINST THE BASE PLATE. THE CASE WAS NOT DELAYED AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650797 ↗
• MalfunctionJan 14, 2025Failure to Advance; Failure to Advance

  ON 12/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06737971 THAT AN AR-9563-20 PERIPHERAL SCREW WOULD NOT ENGAGE THE BASEPLATE. THIS EVENT OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21151556 ↗
• InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9564-2442-LAT GLENOSPHERE AND GLENOSPHERE SET SCREW DISENGAGED FROM THE BASEPLATE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 FOR A REVERSE SHOULDER ARTHROPLASTY. POSTOPERATIVELY THE PATIENT EXPERIENCED PAIN AND A CT SCAN REVEALED GLENOSPHERE AND GLENOSPHERE SET SCREW DISENGAGED FROM THE BASEPLATE. ON (B)(6) 2023 THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH A NEW GLENOSPHERE ALONG WITH HUMERAL COMPONENTS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 11/4/2024: DURING THE REVISION SURGERY, THE AR-9502F-39LCPC SUTURECUP, THE AR-9503-3942-3 HUMERAL INSERT, THE AR-9501-07P HUMERAL STEM, THE AR-9582-20 MODULAR POST, THE AR-9563-28 PERIPHERAL LOCKING SCREW, THE AR-9563-16 PERIPHERAL LOCKING SCREW, THE AR-9563-20 PERIPHERAL LOCKING SCREW, THE AR-9562-40NL PERIPHERAL LOCKING SCREW, THE AR-9580-2010-2S BASEPLATE, AND AR-9564-2442-LAT GLENOSPHERE WAS REMOVED. BOTH PROCEDURES WERE PERFORMED BY THE SAME SURGEON AND AT THE SAME FACILITY.

  Patient problems: Pain

  MAUDE report 20725602 ↗
• InjuryAug 22, 2024Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED ON 5/14/2025: THE REVISION SURGERY WAS RESCHEDULED PER PATIENT REQUEST TO (B)(6) 2025. IT WAS LATER RESCHEDULED TO (B)(6) 2025 DUE TO SURGEON AVAILABILITY. AND THEN, RESCHEDULED AGAIN PER PATIENT REQUEST TO (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection; Loss of Range of Motion; Pain

  MAUDE report 20026974 ↗
• InjuryAug 5, 2024Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED ON 11/4/2024: ON 8/2/2024, THE PATIENT'S IMPLANTS WERE CONVERTED FROM FAILED REVERS TO A HEMIARTHROPLASTY DUE TO THE DISPLACED GLENOID COMPONENTS FROM THE BROKEN SCREWS. AT THIS TIME, IT IS UNKNOWN WHICH ARTHREX PRODUCTS FROM THE ORIGINAL SURGERY ON (B)(6) 2023 WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2024.

  Patient problems: Pain

  MAUDE report 19907179 ↗
• MalfunctionMar 5, 2024Defective Device; Defective Device

  ON 02/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-9563-20 UNIVERS REVERS¿ MODULAR GLENOID SYSTEM LOCKING THREADS WERE DEFECTIVE. THIS OCCURRED DURING A PROCEDURE WHERE ANOTHER LOCKING SCREW WAS USED IN ITS PLACE, AND THERE WERE NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835353 ↗
• InjuryFeb 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06459681 THAT AN AR-9660-R CENTRAL POST EXTRACTOR GOT STUCK IN THE IMPLANT DURING IMPLANT REMOVAL. THIS WAS DISCOVERED DURING A REVISION REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 1/31/2024: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2021. DUE TO PAIN, THE PATIENT UNDERWENT REVISION SURGERY. DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9503S-03 HUMERAL INSERT, AN AR-9555-09 UNIVERS REVERS SPACER, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, AN AR-9563-24 PERIPHERAL LOCKING SCREW, AN AR-9563-28 PERIPHERAL LOCKING SCREW, AN AR-9564-2436 GLENOSPHERE, AN AR-9580-2410-2 BASEPLATE, AND AN AR-9582-25 MODULAR POST WERE EXPLANTED. ONLY AN AR-9501-10S UNIVERS REVERS APEX STEM AND AN AR-9502F36RCPC SUTURE CUP REMAINED FROM THE ORIGINAL SURGERY. TO COMPLETE THE REVISION SURGERY, AN AR-9503S-03C HUMERAL INSERT, AN AR-9555-12 UNIVERS REVERS SPACER, AN AR-9560-24-4 BASEPLATE, AN AR-9561-30S CENTRAL SCREW, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, (2) AR-9563-28 PERIPHERAL LOCKING

  Patient problems: Implant Pain

  MAUDE report 18695208 ↗
• InjuryJul 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023 DUE TO AN INFECTION AND LOOSENED BASEPLATE. ON (B)(6) 2023, THE PATIENT COMPLAINED OF PAIN AFTER THE ORIGINAL PROCEDURE ON (B)(6) 2023. DURING THE POST-OPERATIVE VISIT, RADIOGRAPHS INDICATED A LOOSENED BASEPLATE, BUT THE INFECTION TYPE WAS NOT YET CONFIRMED. DURING THE REVISION SURGERY, AN AR-9564-2433-LAT GLENOSPHERE, AN AR-9580-2420 BASEPLATE, AN AR-9582-20 MODULAR POST, AN AR-9501-10S HUMERAL STEM, AN AR-9502F-33CPC SUTURE CUP, AN AR-9503XS-03 HUMERAL INSERT, AN AR-9504-06 HUMERAL SPACER, AN AR-9562-24NL PERIPHERAL NON-LOCKING SCREW, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, AND AR-9563-24 PERIPHERAL LOCKING SCREW WERE EXPLANTED. THE CASE WAS COMPLETED BY TAKING CULTURES FOR FURTHER TESTING AND PLACING ANTIBIOTIC SPACERS. NO ADDITIONAL ARTHREX PRODUCTS WERE IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17364065 ↗
• InjuryJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 5/19/2023, 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 17112095 ↗
• 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) 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 17112055 ↗
• InjuryApr 18, 2023Unexpected Therapeutic Results; Patient Device Interaction Problem; Unexpected Therapeutic Results; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A REVISION SHOULDER ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2023 DUE TO AN INFECTION. THE SURGEON REMOVED AN AR-9580-2420 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE, AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE, AN AR-9562-32NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 32 MM, AN AR-9562-24NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 24 MM, AN AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 20 MM, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 16 MM, AN AR-9564-2436-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9503S-06 ARTHREX UNIVERS REVERS HUMERAL INSERT, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AND AN AR-9501-05P UNIVERS REVERS HUMERAL STEM.ADDITIONAL INFORMATION RECEIVED ON 3/23/2023:THE ORIGINAL PROCEDURE OCCURRED ON 3/22/2021. ABOUT TEN MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE SYMPTOMS OF INFECTION. A CULTURE WAS TAKEN OFF THE INFECTED AREAS, BUT RESULTS ARE STILL PENDING. THE SAME SURGEON AT THE SA

  Patient problems: Unspecified Infection

  MAUDE report 16762939 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 3/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A SHOULDER ARTHROPLASTY REVISION SURGERY TOOK PLACE ON (B)(6) 2023 DUE TO AN INFECTION. THE SURGEON REMOVED AN AR-9560-28 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAR BASEPLATE, AN AR-9502F-42LCPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9564-2842 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9503L-03 ARTHREX UNIVERS REVERS HUMERAL INSERT, (2) AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9562-28NL UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL NON-LOCKING SCREW, AN AR-9562-40NL UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL NON-LOCKING SCREW, AN AR-9561-25P UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL POST MODULA, AND AN AR-9501-05P UNIVERS REVERS HUMERAL STEM.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16582124 ↗
• MalfunctionAug 18, 2022Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2022, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT SHE UNDERWENT A REVERSE SHOULDER REPLACEMENT ON (B)(6) 2021, AND IS NOW EXPERIENCING SUDDEN PAIN TO HER RIGHT SHOULDER WHEN RAISING HER ARM OVERHEAD. X-RAYS SUGGEST A STRESS FATIGUE FRACTURE THROUGH THE INFERIOR SCREW. THIS DEMONSTRATES LOOSENING OF THE LEFT GLENOSHPERE/BASEPLATE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 01/22/2021: IMPLANTED DEVICES ARE AS FOLLOWS: RIGHT REVERSE TSR, ARTHREX UNIVERS 6MM STEM WITH 36/+2 RIGHT SUTURE CUP, SMALL 33/+3 HUMERAL INSERT, 24MM MONOBLOCK BASE PLATE WITH 3 LOCKING SCREWS, +4/33MM GLENOPHERE. A CT SCAN OF THE RIGHT SHOULDER OBTAINED AT (B)(6) HOSPITAL IS AVAILABLE FOR REVIEW. THIS DEMONSTRATES APPROPRIATE POSITIONING OF REVERSE TSR COMPONENTS. A MINIMAL AMOUNT OF FLUID IS SEEN. THERE IS DEGENERATIVE CHANGE A.C. JOINT. NO LUCENCY AROUND THE IMPLANTS. DUE TO THE ARTIFACT THE SCREW FRACTURE IS NOT VISIBLE. AT THIS TIME A REVISION SURGERY WILL NOT TAKE PLACE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Bone Fracture(s); Failure of Implant; Pain

  MAUDE report 15249306 ↗
• InjuryMay 24, 2021Break

  IT WAS REPORTED THAT A REVERSE TOTAL SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2020. SEE ATTACHED PRE-OPERATIVE X-RAYS IMAGES. THE FOLLOWING ARTHREX PRODUCT WAS EXPLANTED DURING THE REVISION SURGERY; AR-9502F-36CPC (LOT: 19.02550), AR-9503-3633-3 (LOT: 19.00009), AR-9560-24-2 (LOT: 6364), AR-9561-20S (LOT: 7039), AR-9562-36NL (LOT: 18.01681 / THIS SCREW WAS BROKEN), AR-9563-20 (LOT: 19.00617), AR-9563-24 (LOT: 2018005452), AR-9564-2433-LAT (LOT: 19.00014). THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE REVISION SURGERY; AR-9502F-36CPC (LOT: 19.04723), AR-9503S-03C (LOT: 19.00504).

  Patient problems: Insufficient Information

  MAUDE report 11872374 ↗
• InjuryMay 10, 2021Break; Fracture; Malposition of Device

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A UNIVERS REVERS APEX AND MODULAR GLENOID SYSTEM (MGS) CONSTRUCT DURING A PRIMARY RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY CASE. THE PATIENT INCREASED ACTIVITY PER THE STANDARD PROTOCOL. AT 19 MONTHS POST-OP, THE PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE. AT THE TIME OF REVISION FOR THE PERIPROSTHETIC FRACTURE, THE PATIENT HAD A STABLE MODULAR GLENOID SYSTEM IMPLANT CONSTRUCT. THE REVERS APEX HUMERAL IMPLANTS WERE REMOVED. THE WRIGHT MEDICAL REVIVE REVISION HUMERAL STEM WAS IMPLANTED DUE TO THE PERIPROSTHETIC FRACTURE. AT 26 MONTHS POST-OP FROM THE INITIAL INDEX REVERSE TOTAL SHOULDER PROCEDURE, THE PATIENT PRESENTED WITH NO FUNCTION. X-RAYS SHOWED A FAILED MODULAR GLENOID SYSTEM IMPLANT CONSTRUCT. THE INFERIOR SCREW WAS BROKEN AND THE IMPLANTS HAD SHIFTED. ON (B)(6) 2021, A SECOND REVISION WAS PERFORMED TO REMOVE THE MODULAR GLENOID SYSTEM IMPLANTS. THE GLENOID IMPLANTS WERE REMOVED IN ONE PIECE WITH NO BONE ON GROWTH. A WRIGHT MEDICAL REVERSE GLENOID CONSTRUCT WAS IMPLANTED IN PLACE. NO INFECTION. ADDITIONAL INFORMATION RECEIVED ON 4/27/2021: THE REP REPORTED THE PRIMARY REVERS TOTAL SHOULDER SURGERY WAS DONE ON (B)(6) 2019. THE RE

  Patient problems: Fall

  MAUDE report 11798452 ↗
• InjuryMar 15, 2021Loosening of Implant Not Related to Bone-Ingrowth

  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: Insufficient Information

  MAUDE report 11485346 ↗