Arthrex® AR-9145-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867057715), received between Nov 1, 2016 and Jun 26, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/2/2023, IT WAS REPORTED BY A PATIENT THAT AN ARTHREX ECLIPSE STEMLESS HUMERAL IMPLANT AND CONVERTIBLE UNIVERSAL GLENOID PRODUCTS WERE IMPLANTED DURING A SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2023. THE PATIENT IS EXPERIENCING A POSSIBLE UNSPECIFIED REACTION. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17199225 ↗
• InjuryDec 21, 2020Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD A REVERSE SHOULDER REPLACEMENT PERFORMED ON (B)(6) 2015. THE PERIPHERAL SCREWS ON THE BASEPLATE HAD BROKEN REQUIRING THE PATIENT TO HAVE A REVISION SURGERY (B)(6) 2020 AT A DIFFERENT FACILITY. THE GLENOID COMPONENTS WERE REVISED AND THE IMPLANT WAS REPLACED WITH AN MGS GLENOID BASEPLATE. EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY AT TIME OF PROCEDURE. THE FOLLOWING ORIGINAL IMPLANTS WERE EXPLANTED: AR-9120-01, GLENOID BASEPLATE, LOT 140122110. AR-9145-30, UNI GLENOID PERIPHERAL LOCKING SCREW, LOT 150018908. AR-9145-24, UNI GLENOID PERIPHERAL LOCKING SCREW, LOT 140123008. ADDITIONAL INFORMATION OBTAINED 12/1/2020: THE PATIENT DID NOT SUFFER ANY TRAUMA OR FALL PRIOR TO THE REVISION. THE SURGEON NOTED THE PATIENT WAS AN ACTIVE GOLFER AND TENNIS PLAYER.

  Patient problems: Failure of Implant

  MAUDE report 11046553 ↗
• InjuryMay 20, 2020Break; Unstable

  IT WAS REPORTED THAT ON (B)(6) 2019 A REVERS SHOULDER ARTHROPLASTY WAS PERFORMED. EVERYTHING WENT WELL AND IT WAS FINISHED SUCCESSFULLY. THE SURGEON WAS SATISFIED AFTER THE CASE. THIS WAS ALSO SHOWED ON THE X-RAYS. APPROXIMATELY 6 MONTHS POST-OP THE PATIENT REPORTED SUBSEQUENTLY FAILING WHILE PUTTING ON TROUSERS. HE FELT AN ISSUE. THIS WAS WHEN THE GLENOID SIDE GAVE WAY. IT WAS AN ELECTIVE REVERS AND NOT A FRACTURE REVERS. X-RAYS WERE DONE ON (B)(6) 2020. A REVISION SURGERY IS PLANNED TO BE ON (B)(6) 2020. UPDATE SWIT: 02-APR-2020: FURTHER INFORMATION WAS RECEIVED: THE REVISION SURGERY WENT AHEAD ON (B)(6) 2020 AFTERNOON. IT WAS REVISED WITH THE NEW MODULAR GLENOID SYSTEM, SUCCESSFULLY USING AN ILIAC CREST GRAFT. EVERYTHING WENT VERY WELL. THE FAILED DEVICES WERE RETRIEVED, HOWEVER BOTH PERIPHERAL SCREWS WERE BROKEN AND THE TIPS REMAIN IN THE PATIENT. BASEPLATE, CENTRAL SCREW & REMAINING PORTION OF PERIPHERAL SCREWS X 2 WILL BE RETURNED ASSEMBLED. ALSO FROM THE HUMERAL SIDE THE CUP AND LINER, WHICH NEEDED TO BE REMOVED FOR ACCESS, WILL BE RETURNED. THERE WAS NO ISSUE WITH THE HUMERAL SIDE, HOWEVER THEY WILL BE RETURNED REGARDLESS. FOLLOW-UP UPDATE ON 29-APR-2020: FURTHER INFORMATIO

  Patient problems: Failure of Implant

  MAUDE report 10074745 ↗
• InjuryApr 22, 2020Break

  IT WAS REPORTED THAT ON (B)(6) 2019 A REVERS SHOULDER ARTHROPLASTY WAS PERFORMED. EVERYTHING WENT WELL AND IT WAS FINISHED SUCCESSFULLY. THE SURGEON WAS SATISFIED AFTER THE CASE. THIS WAS ALSO SHOWED ON THE X-RAYS. APPROXIMATELY 6 MONTHS POST-OP THE PATIENT REPORTED SUBSEQUENTLY FAILING WHILE PUTTING ON TROUSERS. HE FELT AN ISSUE. THIS WAS WHEN THE GLENOID SIDE GAVE WAY. IT WAS AN ELECTIVE REVERS AND NOT A FRACTURE REVERS. X-RAYS WERE DONE ON (B)(6) 2020. A REVISION SURGERY IS PLANNED TO BE ON (B)(6) 2020. UPDATE ON 02-APR-2020: FURTHER INFORMATION WAS RECEIVED: THE REVISION SURGERY WENT AHEAD ON (B)(6) 2020 AFTERNOON. IT WAS REVISED WITH THE NEW MODULAR GLENOID SYSTEM, SUCCESSFULLY USING AN ILIAC CREST GRAFT. EVERYTHING WENT VERY WELL. THE FAILED DEVICES WERE RETRIEVED, HOWEVER BOTH PERIPHERAL SCREWS WERE BROKEN AND THE TIPS REMAIN IN THE PATIENT. BASEPLATE, CENTRAL SCREW & REMAINING PORTION OF PERIPHERAL SCREWS X 2 WILL BE RETURNED ASSEMBLED. ALSO FROM THE HUMERAL SIDE THE CUP AND LINER, WHICH NEEDED TO BE REMOVED FOR ACCESS, WILL BE RETURNED. THERE WAS NO ISSUE WITH THE HUMERAL SIDE, HOWEVER THEY WILL BE RETURNED REGARDLESS.

  Patient problems: Device Embedded In Tissue or Plaque; Fall

  MAUDE report 9985431 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A TOTAL REVERSE SHOULDER PROCEDURE ON (B)(6) 2018 DURING WHICH THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: AR-9502F-36RCPC (LOT 170027905); AR-9502F-36CPC (LOT 170018606); AR-9501-06P (LOT 170088903); AR-9503S-03 (170085610); AR-9504S-INF (LOT 160071710); AR-9120-01 (LOT 170115115); AR-9165-20 (LOT 170056412); AR-9145-24 (LOT 170101712). PATIENT ALSO UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DURING WHICH THE AR-9503S-03 WAS EXPLANTED AND AN AR-9503S-06 (LOT 170150113)WAS IMPLANTED. THE REVISION SURGERY IS BEING REPORTED UNDER CASE (B)(4). PATIENT HAS RECENTLY BEEN ADMITTED TO THE HOSPITAL DUE TO A SHOULDER INFECTION. THE INFECTION IS BEING REPORTED UNDER THE FOLLOWING: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8483595 ↗
• InjuryNov 1, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT A MALE PATIENT HAD UNDERGONE A RIGHT REVERSE TOTAL SHOULDER PROCEDURE APPROXIMATELY TWO YEARS PRIOR IN ANOTHER STATE. ON (B)(6) 2016 PATIENT WAS UNDERGOING A PROCEDURE TO REMOVE THE PRIOR IMPLANTS DUE TO INFECTION. DURING THE PROCEDURE SURGEON WAS USING THE AR-8943-10, T15 HEXALOBE SCREWDRIVER ((B)(4)) AND THE THREADS TWISTED MAKING IT NO LONGER USABLE. THEN THE SURGEON USED THE AR-9202-T15H, UNIVERSAL GLENOID T15 LONG DRIVER ((B)(4)) AND FOUND THE THREADS TWISTED RENDERING IT UNUSABLE. THESE DEVICES ARE FROM LOANER SET RAR-9501GS #14. NO PATIENT INJURY REPORTED. THE CASE WAS COMPLETED USING HOSPITAL OWNED SPARE SCREWDRIVERS WHICH WERE ALSO IN BAD CONDITION. INFORMATION OBTAINED 10/13/16: PRIOR TO THE REVISION PROCEDURE PATIENT HAD A NORMAL BLOODWORK IN 2014, ASPIRATION OF 45CC IN (B)(6) 2016 AND POSITIVE TEST FOR PROPIONBACTERIUM ACNES. AT THE TIME OF THE REVISION AN EXTENDED HOLD CULTURE WAS DONE AND READ ON (B)(6) 2016 AS WELL AS (B)(6) 2016 AND IS CURRENTLY ONGOING. NO AEROBES ISOLATED OR ANEROBIC GROWTH OF BACTERIA FOUND. NO EVIDENCE OF MALIGNANCY. THE FOLLOWING PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9504L-04 ((B)(4)), AR-9502-42RCPC ((B)(4

  Patient problems: Bacterial Infection

  MAUDE report 6068939 ↗