Arthrex® AR-9561-20PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867296510), received between Nov 18, 2020 and Oct 15, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 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 20449806 ↗
• MalfunctionApr 26, 2024Fitting Problem; Fitting Problem

  ON 10/28/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9105-03 GLENOID DIDN'T FIT AND THE AR-9561-20P CENTRAL POST WOULD NOT ENGAGE. THIS WAS DISCOVERED DURING USE IN A REVERSE ARTHROPLASTY ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-9105-03 AND AR-9561-20P.

  Patient problems: Insufficient Information

  MAUDE report 19195442 ↗
• 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 11798518 ↗
• 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: Failure of Implant

  MAUDE report 11484738 ↗
• InjuryNov 18, 2020Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT HAD UNDERGONE A SHOULDER PROCEDURE (B)(6) 2020. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED AT THE TIME OF ORIGINAL SURGERY: PART NUMBER, LOT NUMBER: AR-9560-24-2, 7266; AR-9561-20P, 7181; AR-9562-20NL, 2018001453; AR-9562-24NL, 2019001012; AR-9563-16, 2019004170; AR-9563-16, 2019003483; AR-9564-2436-LAT, 19.03388. THE PATIENT IS SCHEDULED TO HAVE A SECOND SURGERY (B)(6) 2020. UPDATED INFORMATION PROVIDED (B)(6) 2020: THE PATIENT BEGAN EXPERIENCING PAIN APPROXIMATELY 4 WEEKS PRIOR TO THE REPORT TO ARTHREX. SERIAL X-RAYS DIAGNOSED GLENOID BASEPLATE LOOSENING. THE REVISION SURGERY TOOK PLACE (B)(6) 2020 AS SCHEDULED. DURING THE REVISION SURGERY ALL ORIGINAL ARTHREX PRODUCTS, LISTED IN THE INITIAL REPORT, WERE EXPLANTED. ONCE THE BASEPLATE WAS REMOVED, ANOTHER MANUFACTURER'S BASEPLATE, PERIPHERAL SCREWS AND GLENOSPHERE WERE IMPLANTED. SEVERAL CULTURE WERE TAKEN AND SENT FOR RAPID TEST TO THE LAB. RAPID TEST RESULTS RETURNED INDICATING LESS THAN 1 NEUTROPHIL. ARTHREX SALES REP WHO WAS PRESENT STATES THE SURGEON DID VOICE CONCERN OF THE LACK OF BONY INGROWTH ON THE BACKSIDE OF THE BASEPLATE. UPDATED INFORMATION PROVIDE

  Patient problems: Pain

  MAUDE report 10861653 ↗