Arthrex® AR-9503-3633-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867296596), received between Feb 3, 2020 and Oct 10, 2022 — classified as 6 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2022Fracture; Loose or Intermittent Connection

  ON 08/04/2022, 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 01/22/2021: 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 (B)(6) 2022: IMPLANTED DEVICES ARE AS FOLLOWS: AR-9560-24P, BATCH 8164; AR-9502F-36RCPC, B

  Patient problems: Pain

  MAUDE report 15569651 ↗
• InjuryJun 2, 2022Unstable; Naturally Worn

  ON 5/4/2022, 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. ADDITIONAL INFORMATION RECEIVED ON 5/12/2022: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2019 AND PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON. ON (B)(6) 2019, AN AR-9501-05P HUMERAL STEM, AN AR-9502F-36CPC SUTURE CUP, AN AR-9503-3633-3 HUMERAL INSERTER, (2) AR-9560-24 BASEPLATE, FROM DIFFERENT LOT NUMBERS, AN AR-9561-20S CENTRAL SCREW, AN AR-9561-25S CENTRAL SCREW, (3) AR-9563-16 PERIPHERAL LOCKING SCREWS, ONE BEING FROM A DIFFERENT LOT NUMBER, AND AR-9564-2433 GLENOSPHERE WERE IMPLANTED. SALES REPRESENTATIVE CANNOT CONFIRM WHICH DEVICES WERE EXPLANTED DURING REVISION SURGERY ON (B)(6) 2020. HOWEVER, DURING REVISION SURGERY ON (B)(6) 2020, AN AR-9503-3633-3C HUMERAL INSERTER, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AND AR-9563-16 PERIPHERAL LOCKING SCREW, AR-9

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

  MAUDE report 14573294 ↗
• InjuryOct 26, 2021Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2021, IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO THE LOOSENING OF THE PROSTHETIC JOINT. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 10/5/2021: THE DATE OF PRIMARY PROCEDURE WAS ON (B)(6) 2019 FOR A REVERSE TOTAL SHOULDER REPLACEMENT. THIS PROCEDURE TOOK PLACE AT (B)(6) MEDICAL CENTER, ARTHREX ACCOUNT # (B)(4). THE DATE OF THE REVISION SURGERY WAS ON (B)(6) 2020 FOR A POLY SWAP AND GLENOSPHERE EXCHANGE. THIS REVISION TOOK PLACE AT (B)(6) MEDICAL CENTER, ARTHREX ACCOUNT #(B)(4). THE PART AND LOT NUMBER(S) OF ALL ARTHREX PART(S) THAT WERE EXPLANTED DURING THE REVISION ARE AS FOLLOWED: ON (B)(6) 2020: GLENOSPHERE (AR-9564-2433-LAT, LOT 19.00014 (2024-04-30)), INSERT (AR-9503-3633-3, LOT 19.00010 (2024-04-30)), UNSURE WHICH SPECIFIC SCREW REPLACED. THE PART AND LOT NUMBER(S) OF ALL ARTHREX PART(S) IMPLANTED DURING THE REVISION ARE AS FOLLOWED: ON (B)(6) 2020: UNIV. REV MGS GLENOSPHERE, UNIV. REV. HUMERAL INSERT, UNIV. REV. MGS PERIPHERAL SCREW, (QTY. 1). THIS PATIENT UNDERWENT TWO SEPARATE REVISION(S). CASE NUMBER(S) (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12696687 ↗
• MalfunctionJun 7, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A REVERSE SHOULDER DONE ON (B)(6) 2019. SHE WAS HAVING INFLAMMATION PROBLEMS AT THE SITE; THERE WAS ANOTHER CASE DONE ON (B)(6) 2021 TO REMOVE THE DEVICES. THEY CHECKED FOR INFECTION; TESTS WERE NEGATIVE. THE SURGEON DETERMINED THAT THE STEM AND CUP WERE LOOSE; THEY WERE REMOVED FROM THE PATIENT. A SIZE 8 STEM AND CUP WERE INSERTED INTO THE PATIENT FOR A TOTAL SHOULDER REPAIR.

  Patient problems: Inflammation

  MAUDE report 11947518 ↗
• InjuryMay 24, 2021Break

  IT WAS REPORTED THAT A REVERSE TOTAL SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2020. THE FOLLOWING ARTHREX PRODUCT WAS EXPLANTED DURING THE REVISION SURGERY; AR-9502F-36CPC (LOT: 19.02550), AR-9503-3633-3 (LOT: 19.00009), AR-9560-24-2 (LOT: 6364), AR-9561-20S (LOT: 7039), AR-9562-36NL (LOT: 18.01681 / THIS SCREW WAS BROKEN), AR-9563-20 (LOT: 19.00617), AR-9563-24 (LOT: 2018005452), AR-9564-2433-LAT (LOT: 19.00014). THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE REVISION SURGERY; AR-9502F-36CPC (LOT: 19.04723), AR-9503S-03C (LOT: 19.00504).

  Patient problems: Insufficient Information

  MAUDE report 11872344 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PULMONARY EMBOLISM RESULTING IN INPATIENT HOSPITALIZATION OCCURRED DURING A SHOULDER ARTHROPLASTY PROCEDURE IN WHICH ARTHREX PRODUCT WAS BEING USED. THE PATIENT WAS TREATED WITH CONCOMITANT MEDICATION. THE FACILITY REPORTED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS RECOVERING.

  Patient problems: Pulmonary Embolism

  MAUDE report 11484454 ↗
• 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 9659076 ↗