Arthrex® AR-9562-32NLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867296718), received between Oct 28, 2020 and Apr 4, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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.

• InjuryApr 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED LOOSENING OF HUMERAL SIDE IMPLANTS. THE PATIENT SUFFERED AN INJURY AFTER LIFTING A FIVE-POUND BOX. THE X-RAYS INDICATED A SMALL NON-DISPLACED FRACTURE AND LOOSE HUMERAL COMPONENTS. THE PATIENT UNDERWENT A REVISION RSA AND OFIF PROCEDURE ON (B)(6) 2022. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERSE REVERSE SYSTEM IMPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 3/19/2025: DURING THE REVISION SURGERY ON (B)(6) 2022 AN AR-9564-2842-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, AN AR-9563-16 UNIVERS REVERS PERIPHERAL SCREW, TWO AR-9563-24 UNIVERS REVERS PERIPHERAL SCREW, AN AR-9562-32NL UNIVERS REVERS PERIPHERAL SCREW, AN AR-9502F-42RCPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9501-11P ARTHREX UNIVERS REVERS HUMERAL STEM, AN AR-9550-15 ARTHREX UNIVERS REVERS SPACER, AND AN AR-9503L-06C ARTHREX UNIVERS REVERS HUMERAL INSERT WAS REMOVED. THE CASE WAS COMPLETED WITH NEW ARTHREX UNIVERS REVERS IMPLANTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 21774148 ↗
• InjuryAug 5, 2024Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  ON 7/3/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY HAS BEEN SCHEDULED FOR REVISION SURGERY ON (B)(6) 2024 DUE TO FAILED IMPLANTS AND THE PATIENT IS EXPERIENCING PAIN. THE PATIENT UNDERWENT ORIGINAL SURGERY ON (B)(6) 2023 FOR A UNIVERS REVERS IMPLANT SYSTEM. THE PATIENT WILL SEE THE SURGEON ON (B)(6) 2024 TO DISCUSS THE REVISION SURGERY OF A SHOULDER HEMIARTHROPLASTY VERSUS A REVERS TOTAL SHOULDER ARTHROPLASTY. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 7/30/2024: THE PATIENT IMPLANTS THAT WILL BE REVISED ON (B)(6) 2024 ARE AN AR-9502F-36RCPC ARTHREX UNIVERS REVERS SUTURE CUP, 36, AN AR-9503S-06 ARTHREX UNIVERS REVERS HUMERAL INSERT SMALL / 36 / +6, TWO AR-9562-32NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 32 MM, AN AR-9562-40NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 40 MM, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 16 MM, AN AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 20 MM, AN AR-9564-2436-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID

  Patient problems: Pain

  MAUDE report 19907064 ↗
• InjuryApr 18, 2023Unexpected Therapeutic Results; Patient Device Interaction Problem; Unexpected Therapeutic Results; Patient Device Interaction Problem

  ON (B)(6)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 (B)(6) 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 TH

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 16762119 ↗
• InjuryOct 10, 2022Fracture; Loose or Intermittent Connection

  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: Pain

  MAUDE report 15571974 ↗
• InjuryOct 26, 2021Loosening of Implant Not Related to Bone-Ingrowth

  ON 09/10/2021, 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 BEACHWOOD MEDICAL CENTER, ARTHREX ACCOUNT (B)(4). THE DATE OF THE REVISION SURGERY WAS ON (B)(6) 2019 FOR A POLY SWAP AND ON ANOTHER ON (B)(6) 2020 FOR A POLY SWAP AND GLENOSPHERE EXCHANGE. THESE REVISION(S) TOOK PLACE AT BEACHWOOD MEDICAL CENTER, ARTHREX ACCOUNT (B)(4). THE PART AND LOT NUMBERS OF ALL ARTHREX PARTS THAT WERE EXPLANTED DURING THE REVISION(S) ARE AS FOLLOWED: ON 12/12/2019: INSERT (AR-9503-3633-6, LOT 18.02045 ((B)(6) 2024)), PERIPHERAL SCREW (AR-9562-32NL, LOT 2019001013, ((B)(6) 2024)) ON 2/4/2020: GLENOSPHERE (AR-9564-2433-LAT, LOT 19.00014 (2024-04-30)), INSERT (AR-9503-3633-3, LOT 19.00010 ((B)(6) 2024)), UNSURE WHICH SPECIFIC SCREW REPLACED. THE PART AND LOT NUMBERS OF ALL ARTHREX PARTS IMPLANTED DURING THE REVISION(S) ARE AS FOLLOWED: ON (B)(6) 2019: UNIVERS REVERS MGS PERIPHERAL SCRE

  Patient problems: Insufficient Information

  MAUDE report 12696668 ↗
• InjuryMay 10, 2021Break; Fracture; Malposition of Device

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A UNIVERS REVERS APEX AND MODULAR GLENOID SYSTEM (MGS) CONSTRUCT DURING A PRIMARY RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY CASE. THE PATIENT INCREASED ACTIVITY PER THE STANDARD PROTOCOL. AT 19 MONTHS POST-OP, THE PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE. AT THE TIME OF REVISION FOR THE PERIPROSTHETIC FRACTURE, THE PATIENT HAD A STABLE MODULAR GLENOID SYSTEM IMPLANT CONSTRUCT. THE REVERS APEX HUMERAL IMPLANTS WERE REMOVED. THE WRIGHT MEDICAL REVIVE REVISION HUMERAL STEM WAS IMPLANTED DUE TO THE PERIPROSTHETIC FRACTURE. AT 26 MONTHS POST-OP FROM THE INITIAL INDEX REVERSE TOTAL SHOULDER PROCEDURE, THE PATIENT PRESENTED WITH NO FUNCTION. X-RAYS SHOWED A FAILED MODULAR GLENOID SYSTEM IMPLANT CONSTRUCT. THE INFERIOR SCREW WAS BROKEN AND THE IMPLANTS HAD SHIFTED. ON 02/03/21, A SECOND REVISION WAS PERFORMED TO REMOVE THE MODULAR GLENOID SYSTEM IMPLANTS. THE GLENOID IMPLANTS WERE REMOVED IN ONE PIECE WITH NO BONE ON GROWTH. A WRIGHT MEDICAL REVERSE GLENOID CONSTRUCT WAS IMPLANTED IN PLACE. NO INFECTION. ADDITIONAL INFORMATION RECEIVED ON 4/27/2021: THE REP REPORTED THE PRIMARY REVERS TOTAL SHOULDER SURGERY WAS DONE ON (B)(6) 2019. THE REP C

  Patient problems: Fall

  MAUDE report 11798480 ↗
• InjuryOct 28, 2020Loose or Intermittent Connection

  ADDITIONAL INFORMATION 11/16/20: WHEN THE EXPLANTED PRODUCTS WERE RETURNED FOR EVALUATION THE ORIGINAL HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP, AR-9503M-06 (LOT 18.00568) WAS ALSO RETURNED. IT WAS NOT INCLUDED IN THE ORIGINAL LIST OF EXPLANTED PRODUCTS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10747351 ↗