Arthrex® AR-9501-05PRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867247628), received between Feb 3, 2020 and Feb 11, 2025 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Break; Break

  ON (B)(6) 2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY EXPERIENCED LOOSENING OF THE GLENOID SIDE IMPLANTS ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE THE BASEPLATE REMOVED AND HAD A CTA HEAD IMPLANTED. THIS EVENT WAS INDICATED TO BE RELATED TO THE UNIVER REVERS IMPLANT SYSTEM IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 1/15/2025: THE PATIENT'S INITIAL PROCEDURE WAS ON (B)(6) 2023, AND AN ARTHREX UNIVERS REVERS SYSTEM WAS IMPLANTED. THE PATIENT SUFFERED A FALL AROUND (B)(6) 2023, RESULTING IN A MEDIAL BODY SCAPULAR FRACTURE. AN ORIF PROCEDURE WAS PERFORMED ON (B)(6) 2024. NO INFORMATION WAS PROVIDED REGARDING THE SURGERY ON (B)(6) 2024. A POST-OPERATIVE X-RAY AND CT ON (B)(6) 2024 CONFIRMED THAT THE MEDICAL ASPECT OF THE DURAL PLATING WAS INTACT, BUT THE PATIENT HAD A FRACTURE DISTALLY OVER THE ACROMION, WHICH HAD NOT HEALED. X-RAYS ON (B)(6)2024 ALSO CONFIRMED PROGRESSIVE LOOSENING OF THE PATIENT'S REVERSE PROSTHESIS, WITH A MARKEDLY ANTEVERTED GLENOID BASEPLATE. THE ACROMION BROKE OFF AND WAS SITTING IN THE SOFT TISSUES OF

  Patient problems: Failure of Implant

  MAUDE report 21357525 ↗
• MalfunctionJan 20, 2025Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION RECEIVED ON 1/13/2025: THE PART NUMBER FOR THE UNIVERS REVERS SUTURECUP 33 USED WITH THE NEW HUMERAL STEM IS AR-9502F-33CPC. THIS ISSUE OCCURRED WHEN THE IMPLANTS WERE BEING ASSEMBLED TOGETHER ON THE BACK TABLE BEFORE ANY OF THE IMPLANTS TOUCHED THE PATIENT. THE CASE WAS NO DELAYED IN THE CASE AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

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

  MAUDE report 21190871 ↗
• MalfunctionOct 29, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-9501-05P UNIVERS REVERS HUMERAL STEM AND TWO AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUPS ENGAGED CORRECTLY, BUT THEY WERE LOOSE, ALONG WITH THE TWO AR-9503S-03 UNIVERS REVERS HUMERAL INSERT IN BETWEEN. THE SURGEON COULD WIGGLE THE IMPLANTS AND MAKE THEM MOVE. THE SCREW OF THE TWO AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUPS WAS NOT ENGAGING WITH BOTH AR-9501-05P UNIVERS REVERS HUMERAL STEM. THE CASE WAS COMPLETED BY OPENING A DIFFERENT AR-9501-05P UNIVERS REVERS HUMERAL STEM, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AND AN AR-9503S-03 UNIVERS REVERS HUMERAL INSERT FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED WHEN PUTTING THE PRODUCTS TOGETHER BEFORE INSERTION IN THE PATIENT DURING A RTSA PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED FIFTEEN MINUTES; HOWEVER, IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 20560122 ↗
• MalfunctionOct 29, 2024Positioning Failure; Positioning Failure

  ON 10/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-9501-05P UNIVERS REVERS HUMERAL STEM AND TWO AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUPS ENGAGED CORRECTLY, BUT THEY WERE LOOSE, ALONG WITH THE TWO AR-9503S-03 UNIVERS REVERS HUMERAL INSERT IN BETWEEN. THE SURGEON COULD WIGGLE THE IMPLANTS AND MAKE THEM MOVE. THE SCREW OF THE TWO AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUPS WAS NOT ENGAGING WITH BOTH AR-9501-05P UNIVERS REVERS HUMERAL STEM. THE CASE WAS COMPLETED BY OPENING A DIFFERENT AR-9501-05P UNIVERS REVERS HUMERAL STEM, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AND AN AR-9503S-03 UNIVERS REVERS HUMERAL INSERT FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED WHEN PUTTING THE PRODUCTS TOGETHER BEFORE INSERTION IN THE PATIENT DURING A RTSA PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED FIFTEEN MINUTES; HOWEVER, IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 20560091 ↗
• InjuryAug 20, 2024Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ON 7/24/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY HAS BEEN EXPERIENCING ONGOING AND UNCHANGED ISSUES. THE PATIENT HAS EXPERIENCED INCREASED PAIN IN THE TARGET SHOULDER AND A DECLINE IN RANGE OF MOTION AND STRENGTH OVER SEVERAL MONTHS. A CT ARTHROGRAM RESULTS FROM 1/28/24 WERE INCONCLUSIVE, NOTING POSSIBLE BASEPLATE ETIOLOGY. LAB WORK, PERFORMED ON 1/28/2024, HAS RULED OUT INFECTION. THE SYMPTOMS HAVE BEEN MANAGED WITH SLING USE, CONCOMITANT MEDICATION, AND ACTIVITY MODIFICATION. THE PATIENT IS TO BE SCHEDULED FOR AN EXPLORATORY SURGERY FOR DIAGNOSIS, WITH LIKELY REVISION. IT IS UNKNOWN IF THESE ISSUES ARE RELATED TO THE UNIVERS REVERS APEX DEVICES IMPLANTED ON (B)(6) 2023. THE ARTHREX DEVICE IMPLANTED IN THE PATIENT ARE AN AR-9560-24-2 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE 24 MM +2 LAT, AN AR-9503S-06 ARTHREX UNIVERS REVERS HUMERAL INSERT SMALL / 36 / +6, AN AR-9561-25S UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL SCREW, MODULAR 25 MM, AN AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 24 MM, AN AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPH

  Patient problems: Bacterial Infection; Loss of Range of Motion; Pain

  MAUDE report 20000452 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 7/18/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED BONE FRACTURES IN THE TARGET SHOULDER. THIS EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS DEVICES IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT STARTED TO EXPERIENCE PAIN. IT WAS SUSPECTED THE PATIENT SUFFERED AN ACROMIAL FRACTURE, WHICH WAS CONFIRMED IN APRIL VIA CT SCAN. THE PATIENT WAS IMMOBILIZED IN A SLING FOR SIX WEEKS. ON (B)(6) 2024, THE PATIENT REPORTED NO PAIN; X-RAY IMAGES REVEALED A HEALED FRACTURE. THE PATIENT DID NOT SUFFER A FALL OR HAVE AN INJURY. THE PAIN BEGAN AFTER PHYSICAL THERAPY. THE IMPLANTS ARE NOT LOOSE OR BROKEN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19943965 ↗
• MalfunctionJun 10, 2024Positioning Failure; Positioning Failure

  ON 5/14/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9501-05P UNIVERS REVERS HUMERAL STEM DID NOT ACQUIRE ADEQUATE FIXATION. THIS WAS DISCOVERED DURING A PROXIMAL HUMERUS FRACTURE PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19501595 ↗
• MalfunctionMar 20, 2024Inadequacy of Device Shape and/or Size; Loosening of Implant Not Related to Bone-Ingrowth; Inadequacy of Device Shape and/or Size; Loosening of Implant Not Related to Bone-Ingrowth

  ON 03/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-9502F-33LCPC UNIVERS REVERS SUTURE CUP, AR-9503XS-03C HUMERAL INSERT, AND AN AR-9501-05P UNIVERS REVERS¿ HUMERAL STEM FAILED IN A CASE. THIS OCCURRED DURING A REVERS TOTAL SHOULDER PROCEDURE ON (B)(6) 2024 WHEN THE SURGEON DECIDED TO CHANGE THE POLY SIZE WHEN TRYING TO EXTRACT THE IMPLANT, THE REST OF THE CONSTRUCT BECAME LOOSE. THEY THEN HAD TO EXCHANGE FOR A BIGGER STEM, A NEW SUTURE CUP, AND THE CORRECTLY SIZED POLY.

  Patient problems: Insufficient Information

  MAUDE report 18943703 ↗
• InjuryApr 18, 2023Unexpected Therapeutic Results; Patient Device Interaction Problem; Unexpected Therapeutic Results; Patient Device Interaction Problem

  ON 3/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A REVISION SHOULDER ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2023 DUE TO AN INFECTION. THE SURGEON REMOVED AN AR-9580-2420 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE, AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE, AN AR-9562-32NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 32 MM, AN AR-9562-24NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 24 MM, AN AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 20 MM, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 16 MM, AN AR-9564-2436-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9503S-06 ARTHREX UNIVERS REVERS HUMERAL INSERT, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AND AN AR-9501-05P UNIVERS REVERS HUMERAL STEM. ADDITIONAL INFORMATION RECEIVED ON 3/23/2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2021. ABOUT TEN MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE SYMPTOMS OF INFECTION. A CULTURE WAS TAKEN OFF THE INFECTED AREAS, BUT RESULTS ARE STILL PENDING. THE SAME SURGEON AT THE

  Patient problems: Unspecified Infection

  MAUDE report 16762610 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ON 3/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A SHOULDER ARTHROPLASTY REVISION SURGERY TOOK PLACE ON (B)(6) 2023 DUE TO AN INFECTION. THE SURGEON REMOVED AN AR-9560-28 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAR BASEPLATE, AN AR-9502F-42LCPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9564-2842 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9503L-03 ARTHREX UNIVERS REVERS HUMERAL INSERT, (2) AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9562-28NL UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL NON-LOCKING SCREW, AN AR-9562-40NL UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL NON-LOCKING SCREW, AN AR-9561-25P UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL POST MODULA, AND AN AR-9501-05P UNIVERS REVERS HUMERAL STEM.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16582114 ↗
• MalfunctionNov 21, 2022Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT HAS UNDERGONE REVISION SURGERY DUE TO AN AR-9501-05P UNIVERS REVERS HUMERAL STEM BECOMING LOOSE FROM THE SUTURE CUP. NO FURTHER DETAILS HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 15834790 ↗
• InjuryMay 23, 2022Naturally Worn; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A RIGHT SHOULDER RTSA ON (B)(6) 2019. PATIENT UNDERWENT A REVISION SURGERY DUE TO CHRONIC INSTABILITY OF THE GLENOID, WHICH APPEARED TO BE WORN OUT. HOWEVER, SALES REPRESENTATIVE COULD NOT CONFIRM IF ANY OF THE ARTHREX IMPLANTED DEVICES HAD BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 14468928 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVERSE SHOULDER CASE DONE IN (B)(6) 2020. DUE TO INFECTIONS, ALL THE DEVICES WERE REMOVED ON (B)(6) 2021. AN ANTIBIOTIC SPACER WAS PLACED AT THE SITE; THERE MAY BE A SHOULDER REVISION DONE IN THE FUTURE. REMOVED AR-9501-05P, AR-9502F-36RCPC, AR-9564-2433-LAT, AR-9503-3633-3C, AR-9560-24, AR-9561-30S.

  Patient problems: Unspecified Infection

  MAUDE report 11871873 ↗
• InjuryApr 1, 2020Failure to Advance; Positioning Problem

  IT WAS REPORTED THAT DURING AN ARTHROPLASTY PROCEDURE, WHEN THE SURGEON WAS ATTEMPTING TO SCREW THE SPACER (AR-9555-06) INTO THE SUTURECUP, AR-9502F-36CPC, THE SCREW WOULD NOT ADVANCE FULLY. IT WOULD GO IN FOR ABOUT 3 FULL SCREW DRIVER TWISTS, THEN SQUEAK LOUDLY AND SEEMINGLY BOTTOM OUT BUT REMAIN A FEW MILLIMETERS PROUD. IT WAS SO PROUD THAT THE SURGEON COULD NOT FIT THE POLY LINER (AR-9503S-03C) IN TO THE SPACER. AFTER MANY TRIES, DIFFERENT SCREW DRIVERS AND ANGLES THE SURGEON DECIDED TO TRY A +6 (AR-9503S-06C) LINER IN FEAR THAT THE CUP WAS STRIPPED AND UNABLE TO ACCEPT A SPACER. ONCE THE +6 WAS PUT IN AND INITIAL REDUCTION AND RANGE OF MOTION WAS CARRIED OUT THE SURGEON WAS NOT AT ALL SATISFIED WITH THE FIT. THE SURGEON THEN DECIDED TO TRY THE SPACER AGAIN, THIS TIME A +9 SPACER (AR-9555-09). THIS SPACER SCREWED IN PROPERLY AND PERFECTLY ON THE FIRST TRY WITHOUT RESISTANCE. THE SURGEON USED THE ORIGINAL +3 POLY IN THE SPACER AND REDUCED THE SHOULDER. FURTHER INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 02/18/2020: PROCEDURE BEING PERFORMED WAS A REVISION REVERSE TOTAL SHOULDER FOR AN ORIGINAL PROXIMAL HUMERUS FRACTURE. SPECIFICALLY A HUMERAL STEM CHANGE AND ADDITION O

  Patient problems: Failure of Implant

  MAUDE report 9910259 ↗
• InjuryFeb 3, 2020Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION REVERSE TOTAL SHOULDER TOOK PLACE ON (B)(6) 2020. THE REP REPORTED THE REVISION PROCEDURE WAS DUE TO A HIGH SUSPICION OF AN INFECTION, AND THE BASEPLATE LOOSENING. PRIOR TO THE REVISION PROCEDURE THE PATIENT WAS EXPERIENCING PAIN AND SWELLING AROUND THE SURGICAL SITE. X-RAYS WERE TAKEN DURING A FOLLOW-UP VISIT AND REVEALED THE LOOSENED BASEPLATE. CULTURES WERE TAKEN DURING THE REVISION PROCEDURE AND SENT FOR TESTING. AT THIS TIME AN INFECTION HAS NOT BEEN CONFIRMED. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE REP REPORTED AT THIS TIME THE DATE OF THE PRIMARY SURGERY, AND FULL LIST OF ARTHREX PRODUCT IMPLANTED DURING THE PRIMARY PROCEDURE IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE FOLLOWING ARTHREX PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9503-3633-3 / LOT: 18.00158 / QTY.: 1, AR-9501-05P / LOT: UNKNOWN / QTY.: 1, AR-9555-06 / LOT: 18.01505 / QTY.: 1, AR-9502F-36CPC / LOT: 18.00745 / QTY.: 1, AR-9564-2433-LAT / LOT: 17.04762 / QTY.: 1, AR-9563-16 / LOT: 18.00182 / QTY.: 1. AN ARTHREX BASEPLATE AND SCREW WERE ALSO REMOVED. HOWEVER, THE PART AND LO

  Patient problems: Pain; Swelling

  MAUDE report 9659084 ↗
• InjuryFeb 3, 2020Fracture

  IT WAS REPORTED THAT A REVISION REVERSE TOTAL SHOULDER TOOK PLACE ON (B)(6) 2020. THE REP REPORTED THE REVISION PROCEDURE WAS DUE TO A DISPLACED GREATER TUBEROSITY FRACTURE THAT NEEDED TO BE RETRIEVED. PRIOR TO THE REVISION PROCEDURE THE PATIENT WAS EXPERIENCING PAIN AND A LACK OF RANGE OF MOTION. THE PATIENT HAD A FOLLOW-UP VISIT WITH THEIR SURGEON. X-RAYS TAKEN DURING THE FOLLOW UP VISIT REVEALED A DISPLACED GREATER TUBEROSITY FRACTURE. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE REP REPORTED AT THIS TIME THE DATE OF THE PRIMARY SURGERY, AND FULL LIST OF ARTHREX PRODUCT IMPLANTED DURING THE PRIMARY PROCEDURE IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE FOLLOWING ARTHREX PARTS WERE EXPLANTED DURING THE REVISION; AR-9503S-03 / LOT: 19.00085 / QTY.: 1, AR-9564-2436-LAT / LOT: 18.01595 / QTY.: 1, AR-9502F-36CPC / LOT: 18.01518 / QTY.: 1, AR-9501-05P / LOT: 18.00881 / QTY.: 1. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE REVISION; AR-9564-2436 / LOT: 19.00917 / QTY.: 1. THE REP STATED THE HUMERAL COMPONENTS IMPLANTED DURING THE REVISION PROCEDURE WERE FROM A DIFFERENT MANUFACTURER. ADDI

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9659063 ↗