Arthrex® AR-9501-06PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867249264), received between Sep 24, 2018 and Jun 12, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 5/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9501-06P HUMERAL STEM, AN AR-9502F-36CPC SUTURE CUP, AN AR-9503S-03 HUMERAL INSERT, AN AR-9564-2436-LAT GLENOSPHERE, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, (2)AR-9563-28 PERIPHERAL SCREW, AND (2) AR-9563-20 PERIPHERAL SCREW, WERE EXPLANTED DURING A REVISION SHOULDER ARTHROPLASTY SURGERY ON (B)(6) 2023. ON (B)(6) 2022, THE PATIENT UNDERWENT ORIGINAL SURGERY. THEN ON (B)(6) 2023, THE PATIENT STARTED TO EXPERIENCE PAIN. RADIOGRAPHS APPEARED TO SHOW SOME RADIOLUCENT LINES AROUND THE BASEPLATE. THE PATIENT DID NOT REPORT ANY FALLS OR NOTABLE EVENTS. THE INFECTION TYPE HAS NOT BEEN CONFIRMED. DURING THE REVISION SURGERY, AN AR-9150-21 CA HUMERAL HEAD AND AN AR-9100-05P MONOBLOCK STEM WERE IMPLANTED AS FUNCTIONAL ANTIBIOTIC SPACERS. BOTH PROCEDURES WERE PERFORMED BY THE SAME SURGEON BUT AT DIFFERENT FACILITIES.

  Patient problems: Unspecified Infection

  MAUDE report 17111492 ↗
• InjuryOct 11, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT SHE UNDERWENT A REVERSE SHOULDER REPLACEMENT ON (B)(6) 2021, AND IS NOW EXPERIENCING SUDDEN PAIN TO HER RIGHT SHOULDER WHEN RAISING HER ARM OVERHEAD. X-RAYS SUGGEST A STRESS FATIGUE FRACTURE THROUGH THE INFERIOR SCREW. THIS DEMONSTRATES LOOSENING OF THE LEFT GLENOSHPERE/BASEPLATE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021: IMPLANTED DEVICES ARE AS FOLLOWS: RIGHT REVERSE TSR, ARTHREX UNIVERS 6MM STEM WITH 36/+2 RIGHT SUTURE CUP, SMALL 33/+3 HUMERAL INSERT, 24MM MONO-BLOCK BASE PLATE WITH 3 LOCKING SCREWS,+4/33MM GLENOPHERE. A CT SCAN OF THE RIGHT SHOULDER OBTAINED AT LEHIGH VALLEY HOSPITAL IS AVAILABLE FOR REVIEW. THIS DEMONSTRATES APPROPRIATE POSITIONING OF REVERSE TSR COMPONENTS. A MINIMAL AMOUNT OF FLUID IS SEEN. THERE IS DEGENERATIVE CHANGE TO THE AC JOINT. NO LUCENCY AROUND THE IMPLANTS. DUE TO THE ARTIFACT THE SCREW FRACTURE IS NOT VISIBLE. AT THIS TIME A REVISION SURGERY WILL NOT TAKE PLACE. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 09/21/2022: IMPLANTED DEVICES ARE AS FOLLOWS: AR-9560-24P, BATCH 8164; AR-9502F-36RCPC,

  Patient problems: Failure of Implant; Pain

  MAUDE report 15576605 ↗
• InjuryAug 5, 2020Appropriate Device Problem Term/Code Not Available

  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 10366801 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A TOTAL REVERSE SHOULDER PROCEDURE ON 3/21/2018 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 8483547 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A NURSE AT AN ALLERGIST'S OFFICE THAT A PATIENT HAD RIGHT SHOULDER-REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2017. DURING THE SURGERY THE FOLLOWING PRODUCTS (LOT NUMBERS UNKNOWN) WERE IMPLANTED IN THE PATIENT: AR-9501-06P UNIVERSAL REVERSE HUMERAL STEM, AR-9502-36RCPC UNIVERSAL REVERSE CUP, AR-9145-30 UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW (QTY UNKNOWN) AND AR-9120-01 UNIVERSAL GLENOID BASEPLATE SMALL. IT HAS BEEN REPORTED THAT PATIENT BEGAN HAVING REACTION TYPE SYMPTOMS, LOW GRADE TEMPERATURE - PAIN - RASH, ALMOST IMMEDIATELY AFTER THE PROCEDURE WHICH HAS PERSISTED. NO CULTURES HAVE BEEN TAKEN HOWEVER BLOOD WORK TAKEN SHOWED NO INFECTION INDICATED. PATIENT IS BEING SEEN BY AN ALLERGIST TO ATTEMPT TO DETERMINE IF PATIENT MAY HAVE AN ALLERGY TO THE ARTHREX IMPLANTS. MATERIAL COMPOSITION OF THE PRODUCTS HAS BEEN PROVIDED TO THE REPORTER.

  Patient problems: Fever; Pain; Rash

  MAUDE report 7901906 ↗