Arthrex® AR-9564-2436-LATRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867295681), received between Jun 19, 2019 and Mar 19, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A SUBLUXATION, WHICH RESULTED IN A REVISION OF THE COMPONENTS ON (B)(6) 2023. THE EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX SYSTEM IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 2/25/2025 VIA CLINDEX NOTIFICATION: ON (B)(6) 2023, THE PATIENT REPORTED INSTABILITY, PAIN, AND WEAKNESS. ON (B)(6) 2024, THE PATIENT RETURNED AND REPORTED DIFFICULTY WITH RAISING THE ARM ALONG WITH CONTINUED INSTABILITY, PAIN, AND WEAKNESS. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 3/7/2025. DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9564-2436-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, AN AR-9580-2420-2 UNIVERS REVERS AUGMENTED BASEPLATE, AN AR-9501-10S UNIVERS REVERS APEX HUMERAL STEM, AND AN AR-9503S-03 ARTHREX UNIVERS REVERS HUMERAL INSERT WERE EXPLANTED. THE CASE WAS COMPLETED USING A NEW GLENOSPHERE, A HUMERAL INSERT, A SPACER, AND A BASEPLATE.

  Patient problems: Pain

  MAUDE report 21641144 ↗
• InjuryAug 22, 2024Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED ON 5/14/2025: THE REVISION SURGERY WAS RESCHEDULED PER PATIENT REQUEST TO (B)(6) 2025. IT WAS LATER RESCHEDULED TO (B)(6) 2025 DUE TO SURGEON AVAILABILITY. AND THEN, RESCHEDULED AGAIN PER PATIENT REQUEST TO (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection; Pain

  MAUDE report 20029357 ↗
• InjuryAug 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED ON 11/4/2024: ON (B)(6) 2024, THE PATIENT'S IMPLANTS WERE CONVERTED FROM FAILED REVERS TO A HEMIARTHROPLASTY DUE TO THE DISPLACED GLENOID COMPONENTS FROM THE BROKEN SCREWS. AT THIS TIME, IT IS UNKNOWN WHICH ARTHREX PRODUCTS FROM THE ORIGINAL SURGERY ON (B)(6) 2023 WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2024.

  Patient problems: Pain

  MAUDE report 19907181 ↗
• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 36 CAME LOOSE FROM THE SUTURECUP AND COULD NOT BE SEPARATED. THE TRIAL CA ADAPTER WAS PLACED IN THE SUTURECUP AND THE TRIAL CA HEAD WAS PLACED. AN X-RAY WAS TAKEN, AND IT WAS DETERMINED THAT THE CA HEAD WAS THE APPROPRIATE SIZE. THE TRIALS WERE REMOVED. THE STEM/CUP IMPACTOR HANDLE WAS THREADED INTO THE CA ADAPTER. THE TAB OF THE CA ADAPTER WAS ALIGNED WITH THE LATERAL SLOT OF THE SUTURECUP. THE IMPLANT WAS IMPACTED INTO THE SUTURECUP. THE CA HEAD WAS IMPACTED WITH THE GLENOSPHERE IMPACTOR MAKING SURE THE HOOD OF THE HEAD WAS LATERAL. THE CA ADAPTER CAME LOOSE FROM SUTURECUP. THE SURGEON ASKED FOR A NEW CA ADAPTER AND A CA HEAD AS THEY COULD NOT BE SEPARATED. A SECOND AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER WAS PLACED ON THE IMPACTOR HANDLE AND WAS IMPACTED INTO THE SUTURECUP. THE GLENOSPHERE IMPACTOR WAS USED AS WELL TO SEAT THE ADAPTER INTO THE SUTURECUP BUT WITH LITTLE EFFORT, THE CA ADAPTER COULD BE PULLED FROM THE SUTURECUP. THE SURGEON WAS ABLE TO SEPARATE THE FIRST SET OF IMPLANTS AND TRIED AGAIN TO IMPACT THE CA ADAPTER INTO THE SUTUR

  Patient problems: Failure of Implant

  MAUDE report 19063330 ↗
• InjuryJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 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 IN (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 17111810 ↗
• 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 3/23/2023: THE ORIGINAL PROCEDURE OCCURRED ON 3/22/2021. 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 16762852 ↗
• InjuryMay 31, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDER WENT A PRIMARY REVERSE PROCEDURE AND FELL 14 MONTHS LATER, POST OPERATIVE. IMMEDIATELY AFTER THE FALL, PATIENT EXPERIENCE SHOULDER PAIN RADIOGRAPHS SHOWED EVIDENCE OF A BROKEN AR-9563-32 PERIPHERAL LOCKING SCREW, A SHIFTER BASEPLATE AND GLENOSPHERE. A REVISION SURGERY TOOK PLACE ON (B)(6) 2022 FOR REMOVAL OF AR-9563-32 PERIPHERAL LOCKING SCREW, WHICH WAS ONLY PARTIALLY REMOVED, SURGEON MADE THE DECISION TO LEAVE A PORTION OF THE BROKEN SCREW, AS ATTEMPTING TO RETRIEVE IT MAY HAVE RESULTED IN ADDITIONAL BONE LOSS. AN AR-9563-28 PERIPHERAL LOCKING SCREW, AN AR-9561-25S CENTRAL SCREW, AN AR-9560-24-2 BASEPLATE, AN AR-9564-2436-LAT GLENO SPHERE, AND AN AR-9503S-06 HUMERAL INSERT WERE ALL EXPLANTED DURING REVISION REVERSE TSA PROCEDURE ON (B)(6) 2022. SURGEON COMPLETED CASE IMPLANTING NEW GLENOID IMPLANTS.

  Patient problems: Fall; Foreign Body In Patient; Pain

  MAUDE report 14547426 ↗
• InjuryNov 22, 2021Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9564-2436-LAT GLENOSPHERE (LINE #1) AND AN AR-9503S-03 HUMERAL CUP (LINE #2) WERE EXPLANTED ON (B)(6) 2021 DUE TO A DISLOCATION, CAUSED BY A FALL. THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2021 AND TOOK PLACE AT UNIVERSITY OF MARYLAND REHABILITATION AND ORTHOPEDIC INSTITUTE, ARTHREX ACCOUNT #:(B)(4) (B)(6). THE AR-9564-2439-LAT GLENOSHPERE, AR-9503-3639-3C COMBO HUMERAL INSERT, AND AR-9555-09 SPACER, WERE IMPLANTED DURING THE REPORTED REVISION SURGERY. THE AR-9503-3639-6C HUMERAL INSERT WAS IMPLANTED THEN EXPLANTED AS THE DEVICE WAS THE INCORRECT SIZE.

  Patient problems: Fall

  MAUDE report 12853717 ↗
• InjurySep 7, 2021Device Dislodged or Dislocated

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-9564-2436-LAT GLENOSPHERE WAS EXPLANTED ON (B)(6) 2021 BECAUSE THE 6 WEEK POST-OPERATIVE X-RAY SHOWED THAT IT DISLODGED FROM THE MODULAR GLENOID SYSTEM BASEPLATE.

  Patient problems: Insufficient Information

  MAUDE report 12434253 ↗
• InjuryMay 10, 2021Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INCORRECT SIZED IMPLANTS WERE MISTAKENLY USED DURING A PRIMARY MODULAR GLENOID SYSTEM RTSA SURGERY. THE SIZE OF THE HUMERAL CUP (39) USED WAS MISMATCHED WITH A SIZE 36 GLENOSPHERE. FOLLOWING THE SURGERY, THE MISTAKE WAS NOTICED BY THE AGENCY. THEY PROMPTLY ALERTED THE SURGEON OF THE INCORRECT IMPLANTED PRODUCT. THE SURGEON NOTIFIED THE PATIENT OF THE ERROR, AND THE PATIENT DECIDED TO HAVE THE COMPONENTS CHANGED OUT FOR THE CORRECT SIZES. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO CHANGE OUT THE SIZE OF THE HUMERAL CUP AND GLENOSPHERE. A NEW SPACER AND POLY WERE ALSO ADDED TO MAKE SURE THE COMPONENTS MATCHED. THE PATIENT WAS REVISED WITH THE FOLLOWING MATERIAL; AR-9503M-06 (LOT: 18.00559), AR-9505-06 (LOT: 20.02214), AR-9564-2439-LAT (LOT: 18.00657). THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED DURING THE REVISION SURGERY; AR-9564-2436-LAT (LOT: 20.1788), AR-9505-06 (LOT: 19.04327), AR-9503-3639-6 (LOT: 19.03606).

  Patient problems: Insufficient Information

  MAUDE report 11801964 ↗
• InjuryMar 15, 2021Loose or Intermittent Connection

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO THE LOOSENING OF AN ARTHREX PROSTHETIC JOINT. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2020. THE COMPLICATION WAS REPORTED ON (B)(6) 2020; INDICATING LOOSENING OF PROSTHETIC JOINT AND A REVISION REQUIRED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021. THE FOLLOWING ARTHREX PRODUCT WAS EXPLANTED DURING THE REVISION SURGERY; AR-9560-24 (LOT: 5655); AR-9561-20P (LOT: 7038); AR-9562-36NL (LOT: 2018005757); AR-9562-40NL (LOT: 2018001457); AR-9563-20 (LOT: 2019003063); AR-9564-2436-LAT (LOT: 19.03388); AR-9502F-36RCPC (LOT: 19.00394); AR-9503S-06 (LOT: 170052510). THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE REVISION SURGERY; AR-9502F-36RCPC (LOT: 20.01053); AR-9555-06 (LOT: 170143213); AR-9503S-06 (LOT: 20.01369).

  Patient problems: Failure of Implant

  MAUDE report 11485446 ↗
• InjuryNov 18, 2020Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT HAD UNDERGONE A SHOULDER PROCEDURE (B)(6) 2020. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED AT THE TIME OF ORIGINAL SURGERY: PART NUMBER, LOT NUMBER: AR-9560-24-2, 7266; AR-9561-20P, 7181; AR-9562-20NL, 2018001453; AR-9562-24NL, 2019001012; AR-9563-16, 2019004170; AR-9563-16, 2019003483; AR-9564-2436-LAT, 19.03388. THE PATIENT IS SCHEDULED TO HAVE A SECOND SURGERY (B)(6) 2020. UPDATED INFORMATION PROVIDED (B)(6) 2020: THE PATIENT BEGAN EXPERIENCING PAIN APPROXIMATELY 4 WEEKS PRIOR TO THE REPORT TO ARTHREX. SERIAL X-RAYS DIAGNOSED GLENOID BASEPLATE LOOSENING. THE REVISION SURGERY TOOK PLACE (B)(6) 2020 AS SCHEDULED. DURING THE REVISION SURGERY ALL ORIGINAL ARTHREX PRODUCTS, LISTED IN THE INITIAL REPORT, WERE EXPLANTED. ONCE THE BASEPLATE WAS REMOVED, ANOTHER MANUFACTURER'S BASEPLATE, PERIPHERAL SCREWS AND GLENOSPHERE WERE IMPLANTED. SEVERAL CULTURE WERE TAKEN AND SENT FOR RAPID TEST TO THE LAB. RAPID TEST RESULTS RETURNED INDICATING LESS THAN 1 NEUTROPHIL. ARTHREX SALES REP WHO WAS PRESENT STATES THE SURGEON DID VOICE CONCERN OF THE LACK OF BONY INGROWTH ON THE BACKSIDE OF THE BASEPLATE. UPDATED INFORMATION PROVIDE

  Patient problems: Pain

  MAUDE report 10861844 ↗
• InjurySep 16, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT 1/22/19 A PATIENT HAD A REVERSE SHOULDER PROCEDURE. ON 8/25/20 THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT HAD AN AUTOGRAFT TO THE GLENOID ON HER INITIAL SURGERY AND IT DID NOT APPEAR TO HAVE HEALED. THE SALES REPRESENTATIVE WHO WAS PRESENT DURING THE REVISION REPORTS THAT THE SURGEON HAD MENTIONED IN SURGERY THAT HE BELIEVED THAT THE LOCKING MECHANISM ON THE BASEPLATE MAY NOT HAVE BEEN FUNCTIONING APPROPRIATELY (THE SCREW WAS NOT LOCKED IN). DURING THE ORIGINAL PROCEDURE THE FOLLOWING ARTHREX DEVICES HAD BEEN IMPLANTED: AR-9564-2436-LAT, GLENOSPHERE, LOT 18.00689 , AR-9503S-03, HUMERAL INSERT, LOT 18.00870 , AR-9502F-36CPC, UNIVERS REVERS SUTURE CUP, LOT 170141708, AR-9561-25P, MODULAR CENTRAL POST, LOT 5368 , AR-9560-24-2, MODULAR BASEPLATE, LOT 5408 , AR-9562-36NL, PERIPHERAL SCREW NON-LOCKING, LOT 2018001207 , AR-9563-36, PERIPHERAL SCREW LOCKING, LOT 2018001490 , AR-9563-40, PERIPHERAL SCREW LOCKING, LOT 2018001491 , AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, LOT 170125705. DURING THE REVISION SURGERY ALL OFF THE ABOVE LISTED ORIGINAL IMPLANTS WERE EXPLANTED, EXCEPT FOR THE AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, WHICH WAS LEFT I

  Patient problems: Impaired Healing

  MAUDE report 10540321 ↗
• InjuryAug 17, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE AN SHOULDER PROCEDURE (B)(6) 2019. DUE TO UPPER ARM/ BICEPS TENDON PAIN AND DISCOMFORT THE ORIGINAL SURGEON PERFORMED A REVISION RTSA PROCEDURE (B)(6) 2020 AT THE SAME FACILITY. DURING THE REVISION PROCEDURE WHILE ATTEMPTING TO REMOVE THE CUP SCREW FROM THE ORIGINAL PROCEDURE THE DRIVER TIP TWISTED AND THE SCREW STRIPPED. SALES REP STATES NOTHING OUT OF THE ORDINARY WAS NOTICED/ MENTIONED BY THE SURGEON DURING THE PROCEDURE. THE REVISION WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION AND EXCHANGED FOR LARGER SIZES: AR-9564-2436-LAT (LOT 18.01992), AR-9501-07P (LOT 18.02015), AR-9502F-36RCPC (LOT 170111405), AR-9503S-06 (LOT 19.00773), AR-9502RSC (LOT 18.01082). THE EXPLANTED DEVICES ARE NOT AVAILABLE TO RETURN FOR EVALUATION.

  Patient problems: Discomfort; Pain

  MAUDE report 10414375 ↗
• InjuryMay 20, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL REVERSE SHOULDER PROCEDURE WITH MODIFIED GLENOID SYSTEM IN (B)(6) 2019. THE PATIENT HAD RECENTLY UNDERGONE A REVISION PROCEDURE ON (B)(6) 2020 DUE TO PAIN AND CONSTRUCT DISLOCATION. AT THE (B)(6) REVISION, THE HUMERAL INSERT WAS EXPLANTED AND A SPACER AND NEW INSERT WERE IMPLANTED. THE (B)(6) 2020 REVISION WAS REPORTED UNDER CASE (B)(4). ON (B)(6) 2020, THE PATIENT HAD A THIRD PROCEDURE DUE TO NEUROPATHY; THE FOLLOWING DEVICES WERE ALL EXPLANTED: IMPLANTS: AR-9503S-03C (LOT 19.00210), AR-9555-06 (LOT 16.01037), AR-9564-2436-LAT (LOT 19.00689) AND AR-9560-24 (LOT 02191932) AND 4 SCREWS: AR-9563-16, AR-9563-28 (QTY2) AND AR-9563-20 TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING DEVICES: AR-9502-36ARCA (LOT 18.00755) AND AR-9550-19RCA (LOT 10071328).

  Patient problems: Neuropathy; Pain

  MAUDE report 10074339 ↗
• InjuryMay 6, 2020Loose or Intermittent Connection

  IT WAS REPORTED DURING A REVISION REVERSE SHOULDER TO A CLOSED REDUCTION PROCEDURE ON (B)(6) 2020, THE SURGEON WAS CHECKING IF THE PERIPHERAL SCREWS OF THE 24MM +2 MGS BASEPLATE WERE LOOSE. WHEN THE SURGEON TIGHTENED THE SCREWS, THE BLUE HANDLE OF THE AR-1999HH, RATCHETING HANDLE WAS CLICKING AND DID NOT HAVE A POSITIVE STOP. THE SURGEON DETERMINED THAT THE MGS BASEPLATE WAS LOOSE, SO THEY PROCEEDED TO EXPLANT THE SCREWS AND BASEPLATE WITHOUT ANY ISSUES. THE MGS BASEPLATE WAS IMPLANTED PRIOR TO THE REVISION SURGERY. THE IMPLANTS WERE CONVERTED TO TORNIER. AT THE TIME OF INITIAL REPORT TO ARTHREX NO FURTHER DETAILS WERE AVAILABLE. ADDITIONAL INFORMATION OBTAINED 4/13/20 AND 4/15/20: THE INITIAL REPORT PROVIDED WAS NOT A COMPLETE DESCRIPTION AND FURTHER, MORE DETAILED, INFORMATION HAS BEEN OBTAINED TO CLARIFY THE ENTIRE PATIENT RELATED EVENTS. THE FEMALE PATIENT UNDERWENT A PRIMARY REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A FALL (DATE UNKNOWN) WHICH RESULTED IN A PERIPROSTHETIC HUMERAL FRACTURE. THE PATIENT UNDERWENT A FIRST REVISION ON (B)(6) 2020 WHERE THE SURGEON EXPLANTED THE FOLLOWING DEVICES AND REPLACED THEM WITH ANOTHER MA

  Patient problems: Joint Dislocation

  MAUDE report 10028320 ↗
• 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 MANUFACT

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9659056 ↗
• InjuryJun 19, 2019Break

  IT WAS REPORTED FIVE DAYS AFTER AN INITIAL LEFT REVERS TSA PROCEDURE, A REVISION PROCEDURE TOOK PLACE WHICH INCLUDED THE REMOVAL OF THE AR-9564-2436-LAT GLENOSPHERE (LOT: 18.00691). THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2019. DURING THE INITIAL PROCEDURE THE TIP OF THE AR-9624, GLENOSPHERE INSERTER BROKE OFF IN THE GLENOSPHERE AND WAS LEFT IMPLANTED IN THE PATIENT (CASE 19935-1). THE EXPLANTED AR-9564-2436-LAT HAS BEEN RETURNED TO ARTHREX ALONG WITH THE BROKEN TIP OF THE AR-9624 THAT WAS LOCATED INSIDE OF IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 06/03/2019: THE REP STATED THE REASON FOR THE REVISION SURGERY WAS DUE TO THE PATIENT HAVING A DISLOCATED AND DISASSOCIATED GLENOSHPHERE WHICH WAS CONFIRMED WITH AN IN-CLINIC X-RAY. THE AR-9564-2436-LAT (LOT: 18.00691) WAS REMOVED DURING THE REVISION AND REPLACED WITH THE EXACT SAME PART AND LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 06/04/2019: THE REP CONFIRMED THE DISLOCATION WAS DISCOVERED DURING THE PATIENTS FOLLOW-UP APPOINTMENT THAT OCCURRED ON (B)(6) 2019. THE REVISION PROCEDURE WAS NOT A PLANNED REVISION, AND TOOK PLACE ON (B)(6) 2019 DUE

  Patient problems: Device Embedded In Tissue or Plaque; Joint Dislocation

  MAUDE report 8711330 ↗