Arthrex® AR-9501-08CPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867061026), received between Feb 10, 2017 and Jun 16, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2020Malposition of Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON HAS STATED THAT THE POSITION OF THE IMPLANTED BASE PLATE IS NOT IN A PROPER POSITION AND THEREFORE THE SURGEON DECIDED TO PERFORM A REVISION SURGERY. DURING THE REVISION SURGERY THE SURGEON DECIDED TO MAKE AN EASIER ACCESS TO THE GLENOID TO REPLACE THE WHOLE PROSTHESES. IT WAS FURTHER REPORTED THAT IT WAS FOUND ON THE X-RAY THAT DUE TO THE POSITION OF THE BASE PLATE A SCAPULAR NOTCHING WAS CAUSED. THE FOLLOWING IMPLANTS WERE EXPLANTED: BASE PLATE AR-9500-01 (PART NUMBER UNKNOWN AS THE PROVIDED ONE IS INCORRECT), GLENOSPHERE AR-9504S-04, STOCK AR-9501-08CPC, 2X PERIPHERE SCREWS (LOCKING) (PART NUMBER UNKNOWN), CENTRAL SCREWS (LOCKING) (PART NUMBER UNKNOWN), PE-INLAY (PART NUMBER UNKNOWN). UPDATE 07-JUN-2020 : FURTHER INFORMATION WERE PROVIDED THAT THAT THE BASE PLATE WAS NOT OPTIMALLY PLACED AND THE PLATE DID NOT SINK. DURING THE SURGERY IT WAS ALSO DISCOVERED THAT THE PLATE HAD GOOD OSSEOINTEGRATION. THE SIZE THE CENTRAL SCREW IS AN AR-9165-15.WN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10158315 ↗
• InjuryFeb 10, 2017Loose or Intermittent Connection

  IT WAS REPORTED BY PATIENT THAT SHE HAD UNDERGONE A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2015. PER THE SALES REP, AT THE TIME OF THE INITIAL SURGERY SURGEON CHOSE NOT TO USE CEMENT. PATIENT REPORTED THE SHOULDER WAS LOOSE AND ON (B)(6) 2016 THE PATIENT UNDERWENT A REVISION PROCEDURE. PER THE SALES REP, DURING THE REVISION IT WAS CONFIRMED THAT THE STEM WAS LOOSE. THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED: UNIVER REVERS STEM, AR-9501-08CPC, LOT: 2501426109 ((B)(4)), UNIVERS REVERS CUP, AR-9502-36CPC, LOT: 2501467210 ((B)(4), AND UNIVERS REVERS HUMERAL INSERT, AR-9503S-06, LOT: 2501337303 ((B)(4)). THE PROCEDURE WAS COMPLETED BY IMPLANTING THE FOLLOWING ARTHREX PRODUCTS: UNIVERS REVERS CUP, AR-9502-36CPC, LOT: 2501496310, UNIVERS REVERS STEM, AR-9501-08CPC, LOT: 2501493110, UNIVERS REVERS HUMERAL INSERT SMALL, AR-9503S-03, LOT: 140104207 AND UNIVERS REVERS SPACER, AR-9555-06, LOT: 2501476207. DURING THE REVISION PROCEDURE THE SURGEON CHOSE TO USE CEMENT. PATIENT INDICATED THAT SHE MAY REQUIRE A THIRD SURGERY AS SHE FEELS THE SAME LOOSENESS IS OCCURRING AGAIN. PATIENT IS PLANNING TO SEE A NEW SURGEON TO ADDRESS THIS POSSIBILITY. PATIENT INQUIRED AS TO WHETHER ANY OF HER IM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6321861 ↗