Arthrex® AR-9561-25SRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867296565), received between Feb 7, 2022 and Dec 9, 2025 — classified as 5 injuries, 11 malfunctions.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CONNECTION BETWEEN THE SCREW AND THE BASEPLATE IS BROKEN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. FURTHER INFORMATION RECEIVED WITH A REGARDING CRM CASE: IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CONNECTION BETWEEN THE SCREW AND THE BASEPLATE IS BROKEN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT 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 23759344 ↗
• 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 23681164 ↗
• 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 22485370 ↗
• 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 21751155 ↗
• MalfunctionSep 25, 2024Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  ON 9/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9561-25S UNIVERS REVERS MODULAR CENTRAL SCREW AND AN AR-9560-24-2 ARTHREX UNIVERS REVERS MODULAS BASEPLATE FAILED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

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

  MAUDE report 20300904 ↗
• InjuryAug 21, 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 20017167 ↗
• MalfunctionMay 24, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9561-25S CENTER SCREW AND AR-9560-24-2 MODULES BASEPLATE DID NOT SEAL TOGETHER ON THE BACK TABLE USING THE MORSE TAPER. THE CASE WAS COMPLETED BY OPENED A NEW BASEPLATE AND SCREW.

  Patient problems: Insufficient Information

  MAUDE report 19398019 ↗
• MalfunctionApr 22, 2024Fitting Problem; Fitting Problem

  ON 10/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9561-25S 25MM CENTRAL SCREW, MODULAR HAD AN ISSUE. DURING A TOTAL REVERSE SHOULDER PROCEDURE ON (B)(6) 2022, WHEN THE SURGEON WAS TRYING TO INSERT THE SCREW INTO THE BASEPLATE ON THE BACK TABLE, IT WOULD NOT SIT FLUSH. THERE WAS NO DAMAGE VISIBLE TO THE EYE, THE SCREW DID NOT LOOK DAMAGED OR BENT IN ANY WAY. AS THE COMPLAINT DEVICE WOULD NOT SIT FLUSH, IT WAS NOT USED IN THE SURGERY. THEY DID NOT HAVE ANOTHER SCREW AT HAND, SO AN AR-9561-25P UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL POST, MODULAR 25 MM WITH LOT NUMBER 14968556 WAS USED TO COMPLETE THE CASE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT, THAT DEVICE DID FIT WELL. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154507 ↗
• MalfunctionApr 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-24-2 MODULAS BASEPLATE DISASSOCIATED FROM AN AR-9561-25S CENTRAL SCREW DURING INSERTION. THIS WAS DISCOVERED DURING A RTSA PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19151813 ↗
• 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 19020587 ↗
• MalfunctionMar 29, 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 ASSEMBLE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008426 ↗
• MalfunctionOct 11, 2022Output Problem

  IT WAS REPORTED ON 09/22/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-28-2 BASEPLATE AND AR-9561-25S MODULAR SCREW WOULD NOT COMPRESS TOGETHER WITH THE MORSE TAPER USING THE TAPER ASSEMBLY PRESS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. PER FACILITY: " IT WAS CONFIRMED THAT THE COMPRESSION LINE BETWEEN MAXIMUM AND MINIMUM WAS ACHIEVED BUT UP INSTERTING THE IMPLANT THE TWO PIECES BECAME DISASSEMBLED. WE WERE ABLE TO RETRIEVE BOTH PARTS SAFELY WITHOUT HARMING THE PATIENT. WE THEN ASSEMBLED TWO NEW PARTS, SAME SIZES, AND IN THE SAME FASHION WITHOUT ISSUES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576790 ↗
• InjuryJun 2, 2022Unstable; 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 14573574 ↗
• 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 14547406 ↗
• InjuryMay 23, 2022Naturally Worn; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A LEFT SHOULDER RTSA ON (B)(6) 2020. ON (B)(6) 2022, 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. DURING THE REVISION SURGERY ON (B)(6) 2022, AN AR-9560-24 UNIVERS REVERS BASEPLATE, AR-9561-25S UNIVERS REVERS CENTRAL SCREW, AN AR-9563-16 UNIVERS REVERS PERIPHERAL SCREW, AN AR-9563-24 UNIVERS REVERS PERIPHERAL LOCKING SCREW, AN AR-9564-2433-LAT UNIVERS REVERS GLENOSPHERE, AN AR-9502F-36CPC UNIVERS REVERS SUTURE CUP, AND AN AR-9503-3633-3C UNIVERS REVERS CONSTRAINED COMBO HUMERAL INSERT WERE REMOVED. SURGEON DID NOT REMOVE THE UNIVERS REVERS STEM THAT WAS IMPLANTED DURING ORIGINAL PROCEDURE ON (B)(6) 2022. TO COMPLETE THE REVISION SURGERY, AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER AND AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD WERE IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14469403 ↗
• InjuryFeb 7, 2022Fracture; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO A DEEP INFECTION. THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2017 FOR A LEFT REVERSE TOTAL SHOULDER REPLACEMENT WERE AN UNIVERS REVERS, GLENOSPHERE SIZE (36MM), GLENOSPHERE OFFSET (4MM LATERAL), STEM FIXATION (PRESSFIT), STEM SIZE (6), AND SUTURECUP (NEUTRAL) WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 1/20/2022: THE FIRST COMPLICATION WAS REPORTED ON (B)(6) 2018 FOR A SHOULDER INFECTION. THE DATE OF THE REVISION PROCEDURE WAS (B)(6) 2019 FOR A REVERSE ARTHROPLASTY WITH REMOVAL OF ANTIBIOTIC SPACER. AN AR-9560-24-4 AND AN AR-9561-25S WERE EXPLANTED. DEVICE(S) WERE DISCARDED. A SECOND COMPLICATION WAS REPORTED ON (B)(6) 2019 DUE TO A PATIENT FALL, RESULTING IN A PERIPROSTHETIC FRACTURE. THIS COMPLICATION WAS TREATED WITH A BRACE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 13471412 ↗