Arthrex® AR-9556-22RCARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867229594), received between Aug 5, 2020 and Apr 17, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 36 UNIVERS REVERS CA HUMERAL HEAD ADAPTER AND A CA HUMERAL HEAD DISENGAGED FROM AN AR-9502F-39CPC ARTHREX UNIVERS REVERS SUTURECUP AND HUMERAL STEM. THEN, THE 36 UNIVERS REVERS CA HUMERAL HEAD ADAPTER AND THE CA HUMERAL HEAD COULD NOT BE TAKEN APART. SIZING WAS THOUGHT TO BE AN ISSUE, SO THE SURGEON ATTEMPTED TO ENGAGE A 39 SUTURECUP AND AN AR-9502-39ARCA 39 HUMERAL HEAD ADAPTER ON THE BACK TABLE, BUT THEY KEPT COMING APART. THE CASE WAS COMPLETED USING A 36 HUMERAL HEAD ADAPTER. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2025. THIS ISSUE ADDED AN ADDITIONAL HOUR AND A HALF TO THE CASE WHICH ALREADY NEEDED A TIME LIMIT DUE TO THE PATIENT'S HEALTH AND WAS AT A HIGHER RISK FOR SURGERY. AT THIS TIME, IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. ADDITIONAL INFORMATION WAS RECEIVED ON 3/31/2025: THE SALES REPRESENTATIVE PROVIDED THE PART NUMBER: AR-9501-10P FOR THE ARTHREX UNIVERS REVERS HUMERAL STEM, AR-9550-19RCA FOR THE ARTHREX UNIVERS REVERS CA HUMERAL HEAD, AND AR-9556-22RCA UNIVERS REVERS CA HUMERAL HEAD. THE AR-9501-10P FOR THE ARTHREX UNIVERS REVERS HUMERAL STEM WAS NOT EXCHANGED AND WAS THE SAME

  Patient problems: Insufficient Information

  MAUDE report 21858059 ↗
• InjuryMar 6, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE FOLLOWING ARTHREX PARTS (QTY. 2) OF AN AR-9502-42ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 42, AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39, AR-9556-22RCA UNIVERS REVERS CA HUMERAL HEAD 56/22, AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURE CUP, 42, AR-9502F-39CPC ARTHREX UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL), AR-9501-10P ARTHREX UNIVERS REVERS HUMERAL STEM, SIZE 10 WERE UNSUCCESSFUL IN SEATING THE 42 ADAPTER INTO THE 42 CUP. A 39 ADAPTER AND A 39 CUP WERE ALSO ATTEMPTED BUT UNSUCCESSFUL IN PROPERLY SEATING. NOTHING BROKE INSIDE THE PATIENT. THE PROCEDURE WAS ABORTED. THIS WAS DISCOVERED DURING A REVISION REVERSE SHOULDER PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 21536289 ↗
• InjuryJun 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON MAY 1ST, 2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED, RESULTING IN REVISION SURGERY TO A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023 WITH CTA HEAD AND GLENOID GRAFTING. ADDITIONAL INFORMATION RECEIVED ON 5/16/2024. THE ORIGINAL TSA PROCEDURE WAS PERFORMED ON (B)(6) 2009. THE IMPLANTS USED IN THE ORIGINAL PROCEDURE WERE PRODUCTS FROM ANOTHER MANUFACTURING COMPANY. ON (B)(6) 2023, THE PATIENT WAS SEEN BY THE SURGEON DUE TO SEVERAL YEARS OF PAIN, AND IT WAS CONFIRMED VIA CT ARTHROGRAM THAT THE IMPLANTS HAD LOOSENED, AND THE PATIENT HAD SEVERAL ROTATOR CUFF TEARS. ON (B)(6) 2023, THE PATIENT WAS REVISED FROM A TSA TO A HEMIARTHROPLASTY IN WHICH THE SURGEON IMPLANTED A CTA HEAD AND GLENOID BONE GRAFT. SOON AFTER THE SURGERY, THE PATIENT STILL EXPERIENCED PAIN AND THE SURGEON SUGGESTED THE PATIENT MIGHT BE A CANDIDATE FOR A STATE PROCEDURE TO PUT IN A BASEPLATE. ON (B)(6) 2024, THE PATIENT UNDERWENT A SECOND REVISION SURGERY TO CONVERT THE HEMIARTHROPLASTY TO A REVERS TSA WITH A REPLANT OF THE GLENOID BASEPLATE. ADDITIONAL INFORMATION RECEIVED ON 5/29/2024: DURING THE REVISION

  Patient problems: Pain

  MAUDE report 19605838 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNIVERS REVERS TOTAL SHOULDER PROCEDURE (B)(6) 2019. THE PATIENT WAS EXPERIENCING POST OP PAIN AND AN INFECTION. THE ORIGINAL SURGEON PERFORMED A SECOND SURGERY AT THE SAME FACILITY (B)(6) 2020. DURING THE SECOND SURGERY THE FOLLOWING ORIGINAL ARTHREX PRODUCTS WERE EXPLANTED: AR-9501-06P, UNIVERS REVERS STEM, LOT 18.01910, AR-9502F-42CPC, UNIVERS REVERS SUTURE CUP, LOT 170095605, AR-9502-42ARCA, REVERS ADAPTER ASSEMBLY, LOT 241624, AR-9556-22RCA, REVERS CA HUMERAL HEAD, LOT 10165385. THE EXPLANTED DEVICES WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION OBTAINED 07/22/2020: THE GLENOID IMPLANTS FROM THE ORIGINAL PROCEDURE WERE LEFT IN THE PATIENT. THE ONLY DEVICES EXPLANTED WERE THE ABOVE LISTED IMPLANTS. THE SPECIFIC TYPE OF INFECTION OR ANY CULTURE RESULTS ARE NOT BEING PROVIDED TO THE SALES REP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10366826 ↗