Arthrex® AR-9564-2433-LATRecalls & reported problems
Arthrex, Inc. · 33 +4 LAT/24 Glenosphere · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867295650), received between Feb 3, 2020 and Jan 5, 2026 — classified as 12 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection3
- Positioning Failure3
- Adverse Event Without Identified Device or Use Problem2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Patient Device Interaction Problem2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Defective Device1
Patient problems
- Insufficient Information4
- Failure of Implant3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Pain2
- Unspecified Infection2
- Bone Fracture(s)1
- Pulmonary Embolism1
- Swelling1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Positioning Failure
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A GLENOSPHERE SCREW WOULD NOT LOCK INTO AN AR-9564-2433-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, EVEN AFTER BEING COUNTERSUNK. A NEW GLENOSPHERE SCREW WAS OPENED, BUT IT ALSO FAILED TO LOCK, INDICATING A POSSIBLE ISSUE WITH THE THREADS ON THE GLENOSPHERE. THE FAULTY GLENOSPHERE WAS REMOVED, AND A NEW GLENOSPHERE WAS INSERTED, WHICH FUNCTIONED PROPERLY AND ALLOWED THE PROCEDURE TO BE COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 18-DEC-2025: DURING AN RTSA PROCEDURE, THE SCREW THAT CAME PACKAGED WITH THE GLENOSPHERE FAILED TO LOCK WHILE THE GLENOSPHERE WAS ALREADY IMPLANTED IN THE PATIENT. A NEW SCREW, INDIVIDUALLY PACKAGED AS AN AR-9565 GLENOSPHERE SCREW, WAS OPENED; HOWEVER, THIS SCREW ALSO FAILED. THE ORIGINAL GLENOSPHERE WAS REMOVED, AND THE CASE WAS COMPLETED USING A COMPLETELY NEW GLENOSPHERE ALONG WITH THE SCREW THAT IS PACKAGED WITH THAT GLENOSPHERE. NOTHING BROKE INSIDE THE PATIENT, AND NO FRAGMENTS WERE LEFT BEHIND. THE SURGERY EXPERIENCED AN APPROXIMATE FIVE-MINUTE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 23955942 ↗MalfunctionJan 5, 2026Positioning Failure
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A GLENOSPHERE SCREW WOULD NOT LOCK INTO AN AR-9564-2433-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, EVEN AFTER BEING COUNTERSUNK. A NEW GLENOSPHERE SCREW WAS OPENED, BUT IT ALSO FAILED TO LOCK, INDICATING A POSSIBLE ISSUE WITH THE THREADS ON THE GLENOSPHERE. THE FAULTY GLENOSPHERE WAS REMOVED, AND A NEW GLENOSPHERE WAS INSERTED, WHICH FUNCTIONED PROPERLY AND ALLOWED THE PROCEDURE TO BE COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 18-DEC-2025: DURING AN RTSA PROCEDURE, THE SCREW THAT CAME PACKAGED WITH THE GLENOSPHERE FAILED TO LOCK WHILE THE GLENOSPHERE WAS ALREADY IMPLANTED IN THE PATIENT. A NEW SCREW, INDIVIDUALLY PACKAGED AS AN AR-9565 GLENOSPHERE SCREW, WAS OPENED; HOWEVER, THIS SCREW ALSO FAILED. THE ORIGINAL GLENOSPHERE WAS REMOVED, AND THE CASE WAS COMPLETED USING A COMPLETELY NEW GLENOSPHERE ALONG WITH THE SCREW THAT IS PACKAGED WITH THAT GLENOSPHERE. NOTHING BROKE INSIDE THE PATIENT, AND NO FRAGMENTS WERE LEFT BEHIND. THE SURGERY EXPERIENCED AN APPROXIMATE FIVE-MINUTE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 23955831 ↗InjuryApr 17, 2025Positioning Failure; Patient Device Interaction Problem; Positioning Failure; Patient Device Interaction Problem
ON 2/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-9501-04-135P UNIVERS REVERS STEM WOULD NOT ENGAGE WITH AN AR-9504-06 UNIVERS REVERS SPACER. THE STEM WAS IMPLANTED OVER A MONTH AGO AND IT WOULD NOT ENGAGE. THIS WAS DISCOVERED DURING A REVISION SURGERY. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 3/3/2025: THE PATIENT UNDERWENT AN INITIAL RTSA PROCEDURE ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH TWO AR-9504-06 UNIVERS REVERS SPACERS WOULD NOT ENGAGE WITH THE STEM. ADDITIONAL INFORMATION RECEIVED ON 3/11/2025: THE PATIENT UNDERWENT REVISION SURGERY DUE TO A SHOULDER DISLOCATION. DURING THE REVISION, AN AR-9503XS-06 UNIVERS REVERS MODULAR GLENOID SYSTEM HUMERAL INSERT WAS EXPLANTED AND AN AR-9503-3336-6C UNIVERS REVERS MODULAR GLENOID SYSTEM, CONSTRAINED COMBO HUMERAL INSERT WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED ON 3/24/2025: AR-9564-2433-LAT ARTHREX UNIVERS REVERS GLENOSPHERE WERE EXPLANTED AS WELL. AR-9503-3336-3 UNIVERS REVERS COMBO HUMERAL INSERT WAS ATTEMPTED TO BE USED WITH THE SPACER BUT IT WOULD NOT FIT, SO THE SURGEON TURNED TO AN AR-9503-3336-6C UNIVERS REVERS MODULAR GLENOID
Patient problems: Failure of Implant
MAUDE report 21860207 ↗InjuryMar 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ON 2/10/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A LOOSENING OF THE GLENOID SIDE IMPLANTS. AN X-RAY ON (B)(6) 2024, SHOWED LOSS OF FIXATION OF THE BASEPLATE. THE PATIENT WAS REVISED ON (B)(6) 2024. THE EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 3/7/2025: AR-9580-2410 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE, AN AR-9582-25 MODULAR POST FOR AUGMENTED MGS BASEPLATE, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, THREE AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9564-2433-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AND AN AR-9503XS-03 UNIVERS REVERS MODULAR GLENOID SYSTEM, HUMERAL INSERT WERE EXPLANTED DURING THE REVISION SURGERY.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 21700373 ↗InjuryJul 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
ON 6/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023 DUE TO AN INFECTION AND LOOSENED BASEPLATE. ON (B)(6) 2023, THE PATIENT COMPLAINED OF PAIN AFTER THE ORIGINAL PROCEDURE ON (B)(6) 20203. DURING THE POST-OPERATIVE VISIT, RADIOGRAPHS INDICATED A LOOSENED BASEPLATE, BUT THE INFECTION TYPE WAS NOT YET CONFIRMED. DURING THE REVISION SURGERY, AN AR-9564-2433-LAT GLENOSPHERE, AN AR-9580-2420 BASEPLATE, AN AR-9582-20 MODULAR POST, AN AR-9501-10S HUMERAL STEM, AN AR-9502F-33CPC SUTURE CUP, AN AR-9503XS-03 HUMERAL INSERT, AN AR-9504-06 HUMERAL SPACER, AN AR-9562-24NL PERIPHERAL NON-LOCKING SCREW, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, AND AR-9563-24 PERIPHERAL LOCKING SCREW WERE EXPLANTED. THE CASE WAS COMPLETED BY TAKING CULTURES FOR FURTHER TESTING AND PLACING ANTIBIOTIC SPACERS. NO ADDITIONAL ARTHREX PRODUCTS WERE IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 17363779 ↗InjuryMay 1, 2023Defective Device; Defective Device
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9100-08P UNIVERS II HUMERAL STEM 8MM HAD AN INCLINATION SCREW LOCKED IN POSITION WHEN OPENED. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A BIGGER SIZE (9) PRIMARY STEM. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE, WITH NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THE LOCKED INCLINATION SCREW WAS DISCOVERED DURING IMPLANTATION. THE GLENOID FRACTURE WAS CAUSED BY SCREWING THE GLENOSPHERE TO THE BASE PLATE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THE FAULTY AR-9100-08P ARTHREX UNIVERS II HUMERAL STEM 8MM WAS DISCOVERED PRIOR TO IMPLANTATION. THE SURGEON HAD ORIGINALLY PLANNED FOR AN RSA PROCEDURE BUT DUE TO A FRACTURE OF THE GLENOID WHILE SCREWING IN THE AR-9560-24-2 BASEPLATE AND AN AR-9564-2433-LAT GLENOSPHERE. IT WAS NOT CAUGHT UNTIL THE GLENOSPHERE WAS INSERTED AND THE ENTIRE BASEPLATE ROTATED AND SHIFTED. THE SURGEON PROCEEDED BY REMOVING THE GLENOSPHERE WITH A REMOVAL DEVICE AND THE BASEPLATE WAS PULLED OUT BY HAND. THE CASE WAS COMPLETED USING AN AR-9100-09PC ARTHREX UNIVERS II STEM, SIZE 9. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023; THE PROCEDURE
Patient problems: Bone Fracture(s)
MAUDE report 16844997 ↗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 15571915 ↗InjuryMay 23, 2022Unstable; Naturally Worn
ON 5/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A LEFT SHOULDER RTSA ON (B)(6) 2020. ON (B)(6) 2022, 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. DURING THE REVISION SURGERY ON (B)(6) 2022, AN AR-9560-24 UNIVERS REVERS BASEPLATE, AR-9561-25S UNIVERS REVERS CENTRAL SCREW, AN AR-9563-16 UNIVERS REVERS PERIPHERAL SCREW, AN AR-9563-24 UNIVERS REVERS PERIPHERAL LOCKING SCREW, AN AR-9564-2433-LAT UNIVERS REVERS GLENOSPHERE, AN AR-9502F-36CPC UNIVERS REVERS SUTURE CUP, AND AN AR-9503-3633-3C UNIVERS REVERS CONSTRAINED COMBO HUMERAL INSERT WERE REMOVED. SURGEON DID NOT REMOVE THE UNIVERS REVERS STEM THAT WAS IMPLANTED DURING ORIGINAL PROCEDURE ON (B)(6) 2022. TO COMPLETE THE REVISION SURGERY, AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER AND AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD WERE IMPLANTED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14469027 ↗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 (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 ((B)(6) 2024)), INSERT (AR-9503-3633-3, LOT 19.00010 ((B)(6) 2024)), 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)(6).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12696710 ↗InjuryJun 8, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE POST-OP IMAGES SHOW EITHER THE AR-9560-24 GLENOSPHERE NOT FULLY ENGAGED ON THE AR-9564-2433-LAT BASEPLATE (EVEN THOUGH THE LOCKING SCREW FULLY ENGAGED TO 4NM), OR THE BASEPLATE IS A +4 LATERALIZED BASEPLATE AND WAS MISLABELED. SEE SOURCE DATA AND X-RAY IMAGE ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 5/17/2021: THE REP REPORTED THE THERE WERE NO ISSUES/DEVIATIONS DURING THE PROCEDURE WHEN ATTEMPTING TO ENGAGE THE GLENOSPHERE AND BASEPLATE AND EVERYTHING ENGAGED AS IT NORMALLY WOULD. THE ISSUE WAS NOTICED ON THE SAME DAY THE PRODUCTS WERE IMPLANTED WHILE TAKING POST-OP IMAGES. THE REP REPORTED THE REVISION SURGERY TOOK PLACE ON (B)(6)2021. ADDITIONAL INFORMATION RECEIVED ON 5/17/2021: THE REP REPORTED ONLY THE GLENOSPHERE SCREW WAS EXPLANTED. THE SURGEON RE-IMPACTED THE GLENOSPHERE TO ENSURE TAPPER SEEDING, THEN REPLACED THE GLENOSPHERE SCREW. THE ONLY AVAILABLE X-RAY COPIES ARE PRE-REVISION. THERE ARE NO POST REVISION IMAGES AVAILABLE. PENDING CONFIRMATION ON PART/LOT NUMBER OF EXPLANTED GLENOSPHERE SCREW.
Patient problems: Failure of Implant
MAUDE report 11956399 ↗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 3/6/2020. SEE ATTACHED PRE-OPERATIVE X-RAYS IMAGES. 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) AND AR-9503S-03C (LOT: 19.00504).
Patient problems: Insufficient Information
MAUDE report 11872379 ↗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 11871900 ↗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 11484280 ↗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 L
Patient problems: Pain; Swelling
MAUDE report 9659097 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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