Arthrex® AR-9563-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867296862), received between May 6, 2020 and Mar 4, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Break

  ON (B)(6) 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 02-DEC-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 (B)(6) 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: Pain

  MAUDE report 24512380 ↗
• 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 23586422 ↗
• InjuryMar 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 2/11/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A BONE FRACTURE IN THE TARGETED SHOULDER. ABOUT SEVEN MONTHS POST OPERATION, THE PATIENT MADE A QUICK TURN AROUND AND ENDED UP FRACTURING THE GLENOID CAVITY OF RIGHT SCAPULA. THIS WAS CONFIRMED VIA A CT SCAN ON (B)(6) 2024. THE PATIENTS PAIN BEGAN TO IMPROVE AS OF (B)(6) 2024. THE PATIENT REPORTED DECREASED RANGE OF MOTION ON (B)(6) 2024 AND SHARP PAIN ON (B)(6) 2025. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS SYSTEM IMPLANTED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 2/21/2025: DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD, AN AR-9501-04-135R UNIVERS REVERS STEM, AN AR-9503-3336-3 UNIVERS REVERS MODULAR GLENOID SYSTEM HUMERAL INSERT, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL SCREW, AN AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9563-28 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9564-2436 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOS

  Patient problems: Insufficient Information

  MAUDE report 21559779 ↗
• MalfunctionDec 4, 2024Break; Break

  ON 11/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06704164 THAT AN AR-9625 3.0 MM HEX DRIVER TIP BROKE OFF WHEN TIGHTENING THE LOCKING SCREW INTO THE MGS BASEPLATE. IT WAS RETRIEVED FROM THE SCREW HEAD. THE SURGEON WAS NOT USING THE TORQUE INDICATOR AS PER THEIR PREFERENCE WHEN THE DRIVER BROKE, A REPLACEMENT SCREWDRIVER WAS ATTACHED TO THE TORQUE INDICATOR, AND THE SCREW WAS CONFIRMED TO BE TORQUED DOWN. NO DELAY IN THE CASE AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 11/08/2024: THE TORQUED DOWN SCREW WAS PART NUMBER AR-9563-28 LOT 15202638.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843726 ↗
• InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 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 20726860 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 7/18/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED BONE FRACTURES IN THE TARGET SHOULDER. THIS EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS DEVICES IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT STARTED TO EXPERIENCE PAIN. IT WAS SUSPECTED THE PATIENT SUFFERED AN ACROMIAL FRACTURE, WHICH WAS CONFIRMED IN (B)(6) 2024 VIA CT SCAN. THE PATIENT WAS IMMOBILIZED IN A SLING FOR SIX WEEKS. ON (B)(6) 2024, THE PATIENT REPORTED NO PAIN; X-RAY IMAGES REVEALED A HEALED FRACTURE. THE PATIENT DID NOT SUFFER A FALL OR HAVE AN INJURY. THE PAIN BEGAN AFTER PHYSICAL THERAPY. THE IMPLANTS ARE NOT LOOSE OR BROKEN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19940593 ↗
• MalfunctionJul 5, 2024Damaged Thread; Damaged Thread

  ON 6/6/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9563-28 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW THREADING WAS A BIT OFF AND WOULD NOT GO ALL THE WAY DOWN INTO THE 20-DEGREE AUGMENT BASEPLATE. A LOCKING GUIDE AND A 3.0 DRILL BIT WERE USED. THE SCREW WAS INSERTED WITH A HAND DRIVER, AND WHEN IT GOT TO THE LOCKING PORTION, IT WOULD NOT SIT ALL THE WAY. THE CASE WAS COMPLETED USING A NEW AR-9563-28 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19684185 ↗
• InjuryApr 8, 2024Break; Break

  ON (B)(6) 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 SUT

  Patient problems: Failure of Implant

  MAUDE report 19061933 ↗
• 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 18695275 ↗
• 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 17112132 ↗
• 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 17111953 ↗
• InjuryMay 31, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDER WENT A PRIMARY REVERSE PROCEDURE AND FELL 14 MONTHS LATER, POST OPERATIVE. IMMEDIATELY AFTER THE FALL, PATIENT EXPERIENCE SHOULDER PAIN RADIOGRAPHS SHOWED EVIDENCE OF A BROKEN AR-9563-32 PERIPHERAL LOCKING SCREW, A SHIFTER BASEPLATE AND GLENOSPHERE. A REVISION SURGERY TOOK PLACE ON (B)(6) 2022 FOR REMOVAL OF AR-9563-32 PERIPHERAL LOCKING SCREW, WHICH WAS ONLY PARTIALLY REMOVED, SURGEON MADE THE DECISION TO LEAVE A PORTION OF THE BROKEN SCREW, AS ATTEMPTING TO RETRIEVE IT MAY HAVE RESULTED IN ADDITIONAL BONE LOSS. AN AR-9563-28 PERIPHERAL LOCKING SCREW, AN AR-9561-25S CENTRAL SCREW, AN AR-9560-24-2 BASEPLATE, AN AR-9564-2436-LAT GLENO SPHERE, AND AN AR-9503S-06 HUMERAL INSERT WERE ALL EXPLANTED DURING REVISION REVERSE TSA PROCEDURE ON (B)(6) 2022. SURGEON COMPLETED CASE IMPLANTING NEW GLENOID IMPLANTS.

  Patient problems: Fall; Foreign Body In Patient; Pain

  MAUDE report 14547392 ↗
• InjuryJun 7, 2021Loose or Intermittent Connection; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO DO A 10 DEGREE AUGMENTED MGS GLENOID WITH A 35MM CENTRAL POST. AFTER IMPACTING THE GLENOSPHERE ONTO THE BASEPLATE, THE PATIENT'S GLENOID FRACTURED AND THE ENTIRE CONSTRUCT CAME LOOSE (SEE ATTACHED PICTURE). THE SURGEON WAS NOT SURE IF THEY WERE TOO ANTERIOR WITH THEIR INITIAL GUIDE PIN AND SUBSEQUENT REAMING, POSSIBLY WEAKENING THE BONE ANTERIORLY. THE SURGEON ALSO WENT BI-CORTICAL IN THE VAULT WITH THE CENTRAL POST ((B)(4)) AND DID NOT KNOW IF THIS ULTIMATELY LED TO THE FAILURE. THE SURGEON WAS ABLE TO USE BONE GRAFT FROM THE PATIENT'S RESECTED HUMERAL HEAD TO ADDRESS THE GLENOID FRACTURE AND THEN IMPLANTED A NON-AUGMENTED MGS BASEPLATE AND FINISHED THE PROCEDURE WITHOUT FURTHER ISSUE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11946771 ↗
• InjuryApr 27, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT EXPERIENCED AN INFECTION AFTER UNDERGOING A SHOULDER ARTHROPLASTY PROCEDURE CAUSING THE NEED FOR IMPLANT REMOVAL. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE PRIMARY AND TOOK PLACE AT THE SAME FACILITY AS THE ORIGINAL SURGERY. THE REVISION TOOK PLACE ON (B)(6) 2021. THE PART AND LOT NUMBERS OF EXPLANTED ARTHREX MATERIAL IS CURRENTLY UNKNOWN. THE PATIENT WAS REVISED WITH HEMI-ARTHROPLASTY, USING ARTHREX APEX. ADDITIONAL INFORMATION RECEIVED ON 4/9/2021: THE REP PROVIDED THE PART/LOT NUMBERS OF EXPLANTED ARTHREX PRODUCT THAT WAS REMOVED DURING THE REVISION SURGERY. SEE EXPLANTED MATERIAL LISTED BELOW; AR-9561-25P / LOT: 8013 AR-9560-28-4 / LOT: 6807. AR-9501-06S / LOT: 19.03511. AR-9502F-39LCPC / LOT: 19.02275. AR-9564-2839-LAT / LOT: 19.01015. AR-9564-2839 / LOT: 19.00603. AR-9562-28NL / LOT: 18.00143. AR-9503M-03 / LOT: 18.01724. AR-9505-06 / LOT: 19.03720. AR-9563-28 / LOT: 2019003486 (X 2). AR-9562-28NL / LOT: 2019001689.

  Patient problems: Unspecified Infection

  MAUDE report 11730945 ↗
• MalfunctionApr 1, 2021Improper or Incorrect Procedure or Method; Defective Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO RETRIEVE THE PROSTHESIS. IT WAS FURTHER REPORTED THAT THE DEFECTIVE PROSTHESIS WAS CAUSED DUE TO THE POST OPERATIVE ACTIONS BY THE PATIENT. THE PATIENT DID NOT FOLLOW THE POST OP GUIDELINES AND WAS OVERLOADING THE PROSTHESIS TOO EARLY IN THE GYM.

  Patient problems: Insufficient Information

  MAUDE report 11602446 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT MAY HAVE HAD AN ISSUE AS A RESULT OF SURGERY INVOLVING ARTHREX IMPLANTS. UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT A PATIENT HAD A (B)(6) 2019 REVERSE SHOULDER REPLACEMENT PROCEDURE. AFTER THE NERVE BLOCK HAD WORN OFF, APPROXIMATELY 24 HOURS POST SURGERY THE PATIENT WAS EXPERIENCING NUMBNESS IN THE SURGICAL ARM'S PALM, HALF OF RING FINGER AND THE PINKIE FINGER. THE PATIENT WAS DIAGNOSED WITH ULNAR NERVE PALSY AND TOLD IT MAY TAKE A YEAR TO RESOLVE. PATIENT CONSULTED WITH A NEUROLOGIST, WHO SAID NOTHING COULD BE DONE. THE ULNAR NERVE WAS DAMAGED. NO SECOND SURGERY HAS BEEN PERFORMED. THE FOLLOWING ARE THE ARTHREX PRODUCTS THAT WERE IMPLANTED (B)(6) 2019: AR-9560 28-4, LOT: 6094, AR-9561-25P, LOT: 5685, AR-9502F-39RCPC, LOT: 19.00275, AR-9501-105, LOT: 18.0037, AR-9564-2839-LAT, LOT: 18.02027, AR-9562-28NL,LOT: 2018005880, AR-9503M-06, 19.00667, AR-9563-28, LOT: 2019001687, AR-9563-24, LOT: 19.02242, AR-9562-28NL, LOT: 2018005880.

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

  MAUDE report 10763770 ↗
• 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: Failure of Implant; Neuropathy; Pain

  MAUDE report 10074680 ↗
• InjuryMay 6, 2020Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED DURING A REVISION REVERSE SHOULDER TO A CLOSED REDUCTION PROCEDURE ON (B)(6) 2020, THE SURGEON WAS CHECKING IF THE PERIPHERAL SCREWS OF THE 24MM +2 MGS BASEPLATE WERE LOOSE. WHEN THE SURGEON TIGHTENED THE SCREWS, THE BLUE HANDLE OF THE AR-1999HH, RATCHETING HANDLE WAS CLICKING AND DID NOT HAVE A POSITIVE STOP. THE SURGEON DETERMINED THAT THE MGS BASEPLATE WAS LOOSE, SO THEY PROCEEDED TO EXPLANT THE SCREWS AND BASEPLATE WITHOUT ANY ISSUES. THE MGS BASEPLATE WAS IMPLANTED PRIOR TO THE REVISION SURGERY. THE IMPLANTS WERE CONVERTED TO TORNIER. AT THE TIME OF INITIAL REPORT TO ARTHREX NO FURTHER DETAILS WERE AVAILABLE. ADDITIONAL INFORMATION OBTAINED 04/13/2020 AND 04/15/2020: THE INITIAL REPORT PROVIDED WAS NOT A COMPLETE DESCRIPTION AND FURTHER, MORE DETAILED, INFORMATION HAS BEEN OBTAINED TO CLARIFY THE ENTIRE PATIENT RELATED EVENTS. THE FEMALE PATIENT UNDERWENT A PRIMARY REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A FALL (DATE UNKNOWN) WHICH RESULTED IN A PERIPROSTHETIC HUMERAL FRACTURE. THE PATIENT UNDERWENT A FIRST REVISION ON (B)(6) 2020 WHERE THE SURGEON EXPLANTED THE FOLLOWING DEVICES AND REPLACED THEM WITH ANOT

  Patient problems: No Code Available

  MAUDE report 10028347 ↗