Arthrex® AR-9502-36ARCARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867230378), received between Aug 18, 2021 and Apr 8, 2024 — classified as 2 injuries, 3 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 19061714 ↗
• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 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 SUT

  Patient problems: Failure of Implant

  MAUDE report 19061603 ↗
• MalfunctionMar 12, 2024Failure to Advance; Failure to Advance

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 36 WAS ATTEMPTED TO BE ATTACHED TO THE CUP. UNABLE TO MARRY THE TWO PRODUCTS SUCCESSFULLY. THIS WAS DISCOVERED DURING A RTSA REVISION CASE WHERE A CA HEAD WAS IMPLANTED. THE CASE WAS COMPLETED WITH ANOTHER AR-9502-36ARCA WITH NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED 2/28/24: THE REASON FOR THE REVISION SURGERY WAS THAT THE PATIENT HAD STRYKER HARDWARE IN FROM A PREVIOUS RTSA WHICH WAS INFECTED. THE CASE WAS DELAYED ROUGHLY 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889987 ↗
• MalfunctionAug 18, 2021Mechanical Problem; Unstable

  ON (B)(6) 2021, IT WAS REPORTED BY SALES REPRESENTATIVE VIA PHONE THAT AR-9502-36ARCA REVERS 36MM CA ADAPTER ASSEMBLY (LINE #1) WOULD NOT ENGAGE WITH THE AR-9544-17RCA REVERS 36MM CA ADAPTER ASSEMBLY(LINE # 2) THE SURGEON COULD NOT ACHIEVE THE DESIRED STABILITY. A SECOND AR-9502-36ARCA (LINE #3) WAS OPENED AND THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED USING THE UNIVERSAL 2 STEM AND HEAD SYSTEM WITHOUT ISSUE. THE CASE WAS DELAYED 45 MINUTES. ADDITIONAL INFORMATION 8/2/2021: PER THE SALES REPRESENTATIVE, THE CASE WAS ON JULY 20TH. NO ADDITIONAL ANESTHESIA WAS REQUIRED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12335677 ↗
• MalfunctionAug 18, 2021Failure to Advance

  ON (B)(6) 2021, IT WAS REPORTED BY SALES REPRESENTATIVE VIA PHONE THAT AR-9502-36ARCA REVERS 36MM CA ADAPTER ASSEMBLY (LINE #1) WOULD NOT ENGAGE WITH THE AR-9544-17RCA REVERS 36MM CA ADAPTER ASSEMBLY(LINE # 2) THE SURGEON COULD NOT ACHIEVE THE DESIRED STABILITY. A SECOND AR-9502-36ARCA (LINE #3) WAS OPENED AND THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED USING THE UNIVERSAL 2 STEM AND HEAD SYSTEM WITHOUT ISSUE. THE CASE WAS DELAYED 45 MINUTES. ADDITIONAL INFORMATION 8/2/2021: PER THE SALES REPRESENTATIVE, THE CASE WAS ON (B)(6). NO ADDITIONAL ANESTHESIA WAS REQUIRED TO COMPLETE THE CASE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12335673 ↗