Arthrex® AR-9550-19RCARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867229532), received between Aug 12, 2020 and Apr 17, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 6 most recent of 6 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 21858700 ↗
• 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. TWO WEEKS AFTER THE SURGERY, 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 ON (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 GLENOSPHE

  Patient problems: Bone Fracture(s); Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 21559761 ↗
• InjuryMay 10, 2024Connection Problem; Connection Problem

  ON 6/23/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT DURING A REVISION PROCEDURE, BOTH THE AR-9502-29ARCA, REVERS 39MM CA ADAPTER ASSEMBLY AND, AR-9550-29RCA, REVERS CA HUMERAL HEAD, 50/19, WERE HAVING ISSUES SEATING. THE SURGEON HAD THEM IN THE SUTURE CUP AND THEN AFTER TRIAL REDUCTION, THEY WERE AUGMENTING THE SUBS CAP AND DID AN INTERNAL ROTATION. THE ADAPTOR AND HEAD, BOTH, POPPED OUT OF THE CUP. THE HEAD BECAME STUCK ON THE POST AND THE ADAPTOR WOULD NOT SIT IN THE CUP. IN ORDER TO BE SAFE IT WAS AGREED THAT A NEW IMPLANT BE USED TO COMPLETE THE CASE. THE SURGEON HAD NO ISSUES AFTER SWAPPING OUT THE IMPLANTS, HOWEVER, IT DID ADD TIME TO THE CASE. THE REVISION WAS A CONVERSION FROM A REVERS TOTAL SHOULDER PROCEDURE TO A HEMI DUE TO THE MGS BEING LOOSE AND NOT HOLDING IN THE GLENOID.

  Patient problems: Insufficient Information

  MAUDE report 19290044 ↗
• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/19/2024, 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 SUTUR

  Patient problems: Failure of Implant

  MAUDE report 19061901 ↗
• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/19/2024, 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 SUTUR

  Patient problems: Failure of Implant

  MAUDE report 19061820 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem

  AN ARTHREX EMPLOYEE HAS REPORTED THAT A PATIENT DEVELOPED A INFECTION IN THE SURGICAL AREA. THE PROSTHESIS WAS EXCHANGED. IT WAS FURTHER REPORTED THAT THE CUSTOMER IS LOOKING FOR GERMS ON THE PROSTHESIS. NO FURTHER INFORMATION RECEIVED. UPDATE 30-JULY-2020: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED IN (B)(6) 2019. THE REPORTED PRODUCT WAS REPLACED DURING THE REVISION. THE INFECTION WAS IDENTIFIED ON (B)(6) AND THE REVISION WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 10395113 ↗