Arthrex® AR-9502F-36CPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867234192), received between Feb 3, 2020 and Jul 16, 2025 — classified as 14 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 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.

• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 05/28/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY HAD EXPERIENCED A DEEP INFECTION. ON (B)(6) 2025, THE PATIENT PRESENTED WITH INCREASED SWELLING AND ACHING IN THE OPERATIVE SHOULDER, WITH SYMPTOMS REPORTED TO HAVE BEGUN ABOUT THREE TO FOUR WEEKS PRIOR TO THE CLINIC VISIT ON (B)(6) 2025. THE PATIENT WAS REFERRED FOR SYNOVASURE TESTING ON (B)(6) 2025, AND A VISIT ON (B)(6) 2025 CONFIRMED THE INFECTION. A REVISION WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2025. THE EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX IMPLANTED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 6/20/2025: DURING THE REVISION SURGERY ON (B)(6) 2025, AN AR-9501-11S UNIVERS REVERS APEX HUMERAL STEM, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9503-3639-3 UNIVERS REVERS MODULAR GLENOID SYSTEM COMBO HUMERAL INSERT, TWO AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9563-32 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9564-2439-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPH

  Patient problems: Unspecified Infection

  MAUDE report 22521378 ↗
• MalfunctionJul 16, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9502F-36CPC UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL) AND AN AR-9503-3639-6 36+6 / 39 COMBINATION HUMERAL INSERT FAILED TO LOCK INTO PLACE PROPERLY. THE SURGEON ATTEMPTED TO INSERT THE COMBINATION LINER INTO THE SUTURE CUP, BUT IT WOULD NOT ENGAGE SECURELY. AS NO ADDITIONAL 36+6/39 COMBINATION LINER WAS AVAILABLE IN THE IMPLANT BIN, THE SURGEON HAD TO REMOVE THE ALREADY PLACED IMPLANT, RE-REAM THE GLENOID TO A SIZE 39, AND SWITCH TO ALTERNATIVE IMPLANTS. THIS ISSUE RESULTED IN A 25-MINUTE DELAY TO THE PROCEDURE. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/01/2025: THE ORIGINAL IMPLANT LINER FAILED TO SEAT PROPERLY. ALTHOUGH IT WAS PARTIALLY ENGAGED, IT COULD NOT BE FULLY INSERTED. WHILE ATTEMPTING TO REMOVE THE LINER, THE SURGEON USED AN OSTEOTOME AND INADVERTENTLY BROKE THE LINER INTO TWO PIECES. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. INSTEAD, ALTERNATIVE IMPLANT PART NUMBERS AR-9502F-39CPC AND AR-9503M-06 WERE USED TO COMPLETE THE CASE. THE BONE SOCKET WAS PREPARED USING A SUTURECUP REAMER ON THE HUMERAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518742 ↗
• InjuryJan 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 12/18/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY, FIVE MONTHS POSTOPERATIVE, PRESENTED WITH FULLNESS IN THE ANTERIOR OF THE DELTOPECTORAL INCISION, WHICH HAS TO BE FLUCTUANCE. THE INCISION WAS DRAINED, AND A CULTURE WAS SENT TO THE LAB, WHICH INDICATED AN INFECTION. THE PHYSICIAN DECIDED TO PLACE A PICC LINE FOR IV ANTIBIOTICS. THE PATIENT ALSO UNDERWENT AN EXPLANT PROCEDURE AND HAD AN ANTIBIOTIC CEMENT SPACER IMPLANTED ON (B)(6) 2024. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2024. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX IMPLANT SYSTEM. ADDITIONAL INFORMATION RECEIVED ON 1/3/2024: DURING THE REVISION SURGERY, AN AR-9503-3639-3 HUMERAL INSERT, AN AR-9563-16 PERIPHERAL SCREW, AN AR-9563-24 PERIPHERAL SCREW, AN AR-9563-32 PERIPHERAL SCREW, AN AR-9563-44 PERIPHERAL SCREW, AN AR-9564-2439-LAT GLENOSPHERE, AN AR-9580-2420-2S BASEPLATE, AND AR-9582-25 MODULAR POST WERE EXPLANTED. THE REVISION SURGERY WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 21160448 ↗
• 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 20559325 ↗
• 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 20559217 ↗
• InjuryAug 21, 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; Loss of Range of Motion; Pain

  MAUDE report 20009475 ↗
• InjuryFeb 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/9/2024, IT WAS REPORTED ON CASE NUMBER: (B)(4) BY A SALES REPRESENTATIVE VIA SEMS-06451329 THAT A REVISION REVERSE TSA PROCEDURE OCCURRED ON (B)(6) 2024 FOR UNKNOWN REASONS. DURING THE PROCEDURE, IT WAS REPORTED THAT AN AR-9545-T15-01 DRIVER SHAFT WAS STRIPPED WHEN TRYING TO REMOVE SCREWS FROM THE MGS BASEPLATE. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED PATIENT HARM AND NO FURTHER INFORMATION PROVIDED. NO PIECES BROKE INSIDE THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON WHAT CAUSED THE NECESSARY REVISION SURGERY ON (B)(6) 2024 ON SEMS-06451329 FOR CASE NUMBER: (B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON 1/31/2024: ON 1/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06451329 THAT A PATIENT HAD UNDERGONE A REVISION REVERSE TSA PROCEDURE ON (B)(6) 2024 DUE TO AN INFECTION. ALL COMPONENTS HAD TO BE REMOVED, AND THE SUTURE CUP HAD TO BE SEPARATED FROM THE STEM FOR EXPLANTATION. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2023 AT THE SAME FACILITY. NO NEW PRODUCTS WERE IMPLANTED AFTER EXPLANTATION. THE CASE WAS COMPLETED USING ANOTHER AR-9545-T15-01 DRIVER SHAFT TO REMOVE THE SUTURE CUP. THE SURGEON STATED THE PATIENT'S CURRENT HEALTH STATUS

  Patient problems: Unspecified Infection

  MAUDE report 18623938 ↗
• InjuryJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 5/19/2023, 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 ON (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 17111608 ↗
• 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 3/2/2023 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 THE

  Patient problems: Unspecified Infection

  MAUDE report 16762747 ↗
• InjuryJun 2, 2022Unstable; Naturally Worn

  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. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 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 AND AR-9564-2433 GLENOSPHERE WERE IMPLANTED. SALES REPRESENTATIVE CANNOT CONFIRM WHICH DEVICES WERE EXPLANTED DURING REVISION SURGERY ON 7/17/2020. HOWEVER, DURING REVISION SURGERY ON 7/17/2020, 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,

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

  MAUDE report 14573276 ↗
• InjuryMay 23, 2022Unstable; Naturally Worn

  ON (B)(6) 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: Insufficient Information

  MAUDE report 14469029 ↗
• 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 11947591 ↗
• 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. 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), AR-9503S-03C (LOT: 19.00504).

  Patient problems: Insufficient Information

  MAUDE report 11872342 ↗
• InjurySep 16, 2020Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON (B)(6) 2019 A PATIENT HAD A REVERSE SHOULDER PROCEDURE. ON (B)(6) 2020 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 LE

  Patient problems: Failure of Implant

  MAUDE report 10540379 ↗
• InjuryMay 6, 2020Loosening of Implant Not Related to Bone-Ingrowth

  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 4/13/2020 AND 4/15/2020: 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 10/8/19. 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 3/5/20 WHERE THE SURGEON EXPLANTED THE FOLLOWING DEVICES AND REPLACED THEM WITH ANOTHER MANUFAC

  Patient problems: No Code Available

  MAUDE report 10028334 ↗
• InjuryFeb 25, 2020Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT ON OR ABOUT (B)(6) 2017 THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY SURGERY. IT WAS REPORTED THAT THE OPERATION REQUIRED IMPLANTATION OF A SPECIFIC MILLIMETER-SIZED POLYETHYLENE LINER AND THE WRONG SIZED LINER WAS PROVIDED TO THE SURGEON. IT WAS FURTHER REPORTED THAT THE HARDWARE IMPLANTED DID NOT MATCH THE TRIAL COMPONENTS THE SURGEON HAD SELECTED FOR THE PATIENT AND IMPROPER PROSTHETIC COMPONENTS WERE IMPLANTED CAUSING THE NEED FOR SUBSEQUENT SURGICAL TREATMENT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE INITIAL (B)(6) 2017 PROCEDURE: AR-9503S-03, UNIVERS REVERSHUMERAL INSERT SMALL/36/+3, LOT 170052310. AR-9502F-36CPC, UNIVERS REVER SUTURE CUP, 39(NEUTRAL) (LOT 160117904 OR LOT 170039706 - SPECIFIC LOT UNKNOWN). AR-9501-07CPC, UNIVERS REVERS STEM, SIZE 7, LOT 170035214. AR-9504M-04, UNIVERS REVERS GLENOSPHERE 39 +4 LAT, LOT 160123713. AR-9165-20NL, CENTRAL SCREW, NON-LOCKING, UNI REV, 6.5 X 20MM, LOT 10070240. AR-9145-30, UNI GLENOID-PERIPHERAL LOCKING SCREW, LOT 17009612. AR-9145-24, UNI GLENOID-PERIPHERAL LOCKING SCREW, LOT 160115411. AR-9120-02, UNIVERSAL GLENOID BASEPLATE MEDIUM, LOT 2501470208. ADDITIONAL INFO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9751202 ↗
• 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 9659091 ↗
• 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 9659061 ↗