Arthrex® AR-9145-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867057722), received between Dec 16, 2016 and Aug 11, 2025 — classified as 19 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN ANATOMICAL SHOULDER PROSTHESIS WITH UNIVERSAL GLENOID, THE BASE PLATE COULD NOT BE IMPLANTED COMPLETELY. THE SURGEON REPLACED THE PERIPHER AND CENTRAL SCREW WITHOUT SUCCESS. PER COMPLAINT REPORTER, THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE DW 31-JUL-2025: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED BASE PLATE WAS INITIALLY IMPLANTED FOUR YEARS AGO. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY 3 MONTHS AGO WHERE THE INLAY AR-9121-02 WAS REVISED. THE PATIENT CONTINUED TO HAVE ISSUES AND UNDERWENT THE SECOND REVISION ON (B)(6) 2025. DURING THE REVISION, THE INITIALLY REPORTED EVENT HAS BEEN IDENTIFIED AND THE SURGEON REVISED THE BASE PLATE AND 3 SCREWS.

  Patient problems: Failure of Implant

  MAUDE report 22771543 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DEVICE BROKE INSIDE THE PATIENT. THE DEVICE REMAINED IMPLANTED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21112613 ↗
• InjuryMar 14, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PROSTHESIS HAD TO BE REMOVED AFTER 5 YEARS AS THE GLENOID SPHERE BECAME LOOSENED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 11-MAR-2024: FURTHER INFORMATION WERE PROVIDED THAT ONLY THE GLENOSPHERE BECAME LOOSENED. THE PLATE AND SCREWS DID NOT HAVE ANY ISSUES BUT WERE REPLACED DURING THE REVISION INCLUDING THE INLAY AND THE GLENOSPHERE.

  Patient problems: Failure of Implant

  MAUDE report 18906028 ↗
• InjuryMar 14, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PROSTHESIS HAD TO BE REMOVED AFTER 5 YEARS AS THE GLENOID SPHERE BECAME LOOSENED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 11-MAR-2024: FURTHER INFORMATION WERE PROVIDED THAT ONLY THE GLENOSPHERE BECAME LOOSENED. THE PLATE AND SCREWS DID NOT HAVE ANY ISSUES BUT WERE REPLACED DURING THE REVISION INCLUDING THE INLAY AND THE GLENOSPHERE.

  Patient problems: Failure of Implant

  MAUDE report 18905764 ↗
• InjuryJan 2, 2024Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth; Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING AN INVERSE PROSTHESIS SURGERY THE SCREWS AR-9145-30 (LOT: 22.02176) AND AR-9165-20NL (LOT: 15019430) COULD NOT BE TIGHTENED WHEN THE BASE PLATE AR-9120-02 (LOT: 22.03081) AND THE GLENOSPHERE AR-9504M-04 (LOT: 22.02710) WERE IMPLANTED. AS A RESULT, THE GLENOID DID NOT HOLD AND HAD TO BE REMOVED AGAIN. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. A SECOND SURGERY WAS REQUIRED ON THE (B)(6) 2023. UPDATE AVOE (B)(6) 2023: IT WAS CONFIRMED THAT THE SECOND SURGERY WAS REQUIRED DUE TO THE FAILURE OF THE SCREWS, WHICH DIDN`T LOCK LIKE NORMALLY.

  Patient problems: Failure of Implant

  MAUDE report 18429252 ↗
• InjuryOct 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A LOOSENING OF THE ECLIPSE PROSTHESIS LED TO REVISION TO UNIVERS REVERS. THE FOLLOWING DEVICES WERE INITIALLY IMPLANTED: ECLIPSE HEAD, ECLIPSE TRUNION, ECLIPSE CAGE SCREW AND UNIVERSAL GLENOID INLAY. THE UNIVERSAL GLENOID HAD A GOOD ANCHORAGE, SO THE PE WAS REMOVED AND A GLENOSPHERE WAS INSTALLED. ON THE HUMERAL SIDE AN ECLIPSE REMOVED AND UNIVERS REVERS INSTALLED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE (B)(6) 2023 FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON THE (B)(6) 2017 AND THE FOLLOWING DEVICES WERE IMPLANTED: AR-9145-30 LOT: 160058310. AR-9165-15 LOT: 160064010. AR-9120-01 LOT: 160061912. AR-9145-36 LOT: 160058410. AR-9121-01 LOT: 160101410. AR-9300-41CPC LOT: UNK.

  Patient problems: Failure of Implant

  MAUDE report 17994875 ↗
• MalfunctionMay 25, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ECLIPSE PROSTHESIS SURGERY THE SCREW BROKE OFF WHEN IT WAS SCREWED IN. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. (B)(6) 2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE HEAD OF THE SCREW BROKE OFF WHEN THE SCREW WAS INSERTED AROUND 50%. THE BROKEN HEAD OF THE SCREW WAS RETRIEVED OUT OF THE PATIENT. THE SURGEON WAS NOT REALLY SATISFIED BUT THE CONSTRUCT APPEARED TO BE STABLE AND THEREFORE THE SURGERY WAS FINISHED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007374 ↗
• InjuryApr 28, 2023Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING OF THE BASE PLATE. IT WAS FURTHER REPORTED THAT A SCREW BROKE CAUDAL AND INLAY SHOWED ABRASION. THE GLENOID COMPONENT WAS REMOVED AN A CEREMENT FILLING WAS DONE. NO FURTHER INFORMATION RECEIVED. 17-APR-2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT AN AR-9145-30 WAS THE BROKEN SCREW.

  Patient problems: Failure of Implant

  MAUDE report 16838544 ↗
• InjuryMay 9, 2022Degraded

  IT WAS REPORTED THAT ONE YEAR AFTER THE IMPLANTATION OF A RIGHT SHOULDER TOTAL ENDO-PROSTHESIS ECLIPSE ON (B)(6) 2016, POLYETHYLENE DEGRADATION WAS IDENTIFIED POST-OPERATIVELY. THIS RESULTED IN A BONE DEFECT WHICH LED TO A REVISION SURGERY TO CHANGE THE IMPLANT TO AN INVERSE PROSTHESIS.

  Patient problems: Failure of Implant

  MAUDE report 14336842 ↗
• MalfunctionNov 30, 2021Difficult to Insert; Defective Device; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A UNIVERSE REVERSE SHOULDER SURGERY WHEN TRYING TO INSERT THE 30 MM SCREW INTO THE BASEPLATE & BONE THE SCREWDRIVER SCREWED THROUGH, AS THE SCREW WAS TOO TIGHT. THE SCREWDRIVER WAS DEFECTIVE AND THE DRIVERS BECAME DISTORTED. THE SCREW HEAD HAD TWISTED, COULD NO LONGER BE MOVED AND COULD NOT BE FULLY INSERTED. THE SURGEON KNOCKED THE SCREW FLAT AND INSERTED THE GLENOSPHERE. NO PART OF THE DEVICES BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896739 ↗
• InjuryNov 15, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT 6 YEARS AFTER THE INITIAL SURGERY IN THE (B)(6) A REVISION SURGERY OF THE ECLIPS WITH THE UNIVERSAL GLENOID WAS NECESSARY AS THE PATIENT SUFFERED PAIN IN THE SHOULDER JOINT. THE SUBSCAPULARIS NO LONGER HAD ANY FUNCTION. THEREFORE AN INVERSE PROSTHESIS WAS INDICATED AND A PROTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. AS THE PATIENT WAS ALLERGIC TO METAL NO MODULAR CONVERSION OF THE GLENOID COULD BE PERFORMED. THEREFORE THE UNIVERSAL GLENOID AND THE ECLIPSE HAD TO BE REMOVED. THE SURGEON FURTHER REPORTED THAT DARK TRACES WERE IDENTIFIED BELOW THE TRUNNION. THESES LYSIS FRINGES ARE THE RESULT OF THE PE ABRASION. ONLY SMALL FRAGMENTS OF THE PE INSERT WERE STILL PRESENT. UPDATE 22-FEB-2021 DW. X-RAY PICTURES AND A SURGERY REPORT WAS PROVIDED WITH THE INFORMATION THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017. THE REPORTED EVENT WAS IDENTIFIED ON (B)(6) 2020 VIA SCINTIGRAPHY. UPDATE 26-FEB-2021 DW. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. UPDATE 01-SEP-2021 DW. ADDITIONAL DEVICES WERE RETURNED AND ADDED TO THE CASE. UPDATE 25-OCT-2021 DW. DURING THE EVALUATION AN ADDITIONAL AFFECTED LOT WAS IDENTIFIED AND THEREFORE ADDED TO THE CASE.

  Patient problems: Pain

  MAUDE report 12814146 ↗
• MalfunctionSep 21, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT 6 YEARS AFTER THE INITIAL SURGERY, A REVISION SURGERY OF THE ECLIPSE WITH THE UNIVERSAL GLENOID WAS NECESSARY AS THE PATIENT SUFFERED PAIN IN THE SHOULDER JOINT. THE SUB-SCAPULARIS NO LONGER HAD ANY FUNCTION. THEREFORE AN INVERSE PROSTHESIS WAS INDICATED AND A PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. AS THE PATIENT WAS ALLERGIC TO METAL, NO MODULAR CONVERSION OF THE GLENOID COULD BE PERFORMED. THEREFORE THE UNIVERSAL GLENOID AND THE ECLIPSE HAD TO BE REMOVED. THE SURGEON FURTHER REPORTED THAT DARK TRACES WERE IDENTIFIED BELOW THE TRUNNION. THE LYSIS FRINGES ARE THE RESULT OF THE PE ABRASION. ONLY SMALL FRAGMENTS OF THE PE INSERT WERE STILL PRESENT. UPDATE 22-FEB-2021: X-RAY PICTURES AND A SURGERY REPORT WAS PROVIDED WITH THE INFORMATION THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017. THE REPORTED EVENT WAS IDENTIFIED ON (B)(6) 2020 VIA SCINTIGRAPHY. UPDATE 26-FEB-2021: THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 12506445 ↗
• MalfunctionMay 3, 2021Break; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SCREWING IN OF THE DEVICE (AR-9145-30, LOT 19.02683) THE SCREWDRIVER (AR-9545-115-03) WAS BENT AND BEFORE THE DEVICE WAS FULLY INSERTED THE HEAD OF THE DEVICE BROKE OFF. THE BROKEN OFF HEAD OF THE DEVICE WAS RETRIEVED FROM THE PATIENT, BUT THE REST OF THE DEVICE REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE IMPLANTATION OF A UNIVERSAL GLENOID SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11761339 ↗
• InjuryDec 21, 2020Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD A REVERSE SHOULDER REPLACEMENT PERFORMED ON (B)(6) 2015. THE PERIPHERAL SCREWS ON THE BASEPLATE HAD BROKEN REQUIRING THE PATIENT TO HAVE A REVISION SURGERY (B)(6) 2020 AT A DIFFERENT FACILITY. THE GLENOID COMPONENTS WERE REVISED AND THE IMPLANT WAS REPLACED WITH AN MGS GLENOID BASEPLATE. EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY AT TIME OF PROCEDURE. THE FOLLOWING ORIGINAL IMPLANTS WERE EXPLANTED: AR-9120-01, GLENOID BASEPLATE, LOT 140122110. AR-9145-30, UNI GLENOID PERIPHERAL LOCKING SCREW, LOT 150018908. AR-9145-24, UNI GLENOID PERIPHERAL LOCKING SCREW, LOT 140123008. ADDITIONAL INFORMATION OBTAINED 12/1/2020: THE PATIENT DID NOT SUFFER ANY TRAUMA OR FALL PRIOR TO THE REVISION. THE SURGEON NOTED THE PATIENT WAS AN ACTIVE GOLFER AND TENNIS PLAYER.

  Patient problems: Failure of Implant

  MAUDE report 11046528 ↗
• InjuryNov 23, 2020Break

  IT WAS REPORTED THAT DURING A (B)(6) 2020 REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE THE FOLLOWING ISSUES OCCURRED WITH TWO ARTHREX INSTRUMENTS: INSTRUMENT 1: THE MEDIUM T-15 DRIVER (AR-9545-T15-02 #8001928) HAS BEEN COMPROMISED. WHEN TRYING TO EXTRACT THE CENTRAL SCREW FROM A UNIVERSAL GLENOID, THE TIP OF THE DRIVER BECAME TWISTED AND A SMALL PIECE BROKE OFF INTO THE HEAD OF THE CENTRAL SCREW. THERE WAS A 5 MINUTE DELAY IN SURGERY AS THE SCREW HEAD COULD NO LONGER BE ACCESSED. THE SURGEON USED OSTEOTOMES AROUND THE PERIPHERY OF THE BASEPLATE TO EVENTUALLY EXTRACT THE BASEPLATE AND CENTRAL SCREW AS ONE PIECE. THE INSTRUMENT BROKE INTO TWO PIECES. BOTH PIECES WERE RECOVERED, BUT THE SMALLER PIECE WAS LODGED INTO THE CENTRAL SCREW IMPLANT WHICH WAS NOT AVAILABLE FOR RETURN. THERE WAS NO UNPLANNED INCISION. A SECOND SURGERY IS NOT NECESSARY. DEVICE WILL BE RETURNING FOR EVALUATION. THE EVENT DID NOT OCCUR DURING THE INITIAL USE OF THE DEVICE. INSTRUMENT 2: THE TRINITY BASEPLATE IMPACTOR (AR-9165CDG #(10)051917) HAS BEEN COMPROMISED. THE SURGEON ENGAGED THE ALREADY IMPLANTED BASEPLATE WITH THE IMPACTOR SO THAT IMPACTION MIGHT DISRUPT THE BONY BOND WITH THE BASEPLATE. AFTER

  Patient problems: Foreign Body In Patient

  MAUDE report 10884271 ↗
• InjuryOct 28, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT DUE TO A METALLOSIS THE SHOULDER AND THE ARM OF THE PATIENT TURNED BLACK. THE SURGERY WHICH LED TO THE REPORTED EVENT WAS A SHOULDER PROSTHESIS WHICH WAS PERFORMED ON THE (B)(6) 2015. ACCORDING TO THE CUSTOMER ARTHREX DEVICES WERE IMPLANTED DURING THE INITIAL SURGERY IN 2015. CURRENTLY IT IS NOT KNOWN IN WHICH HOSPITAL THE INITIAL SURGERY TOOK PLACE. THEREFORE NO FURTHER INFORMATION ABOUT THE DETAILED INCIDENT AND THE USED ARTHREX PART NUMBERS ARE CURRENTLY AVAILABLE. UPDATE 12-OCT-2020: INITIALLY THE LOT NUMBERS WHICH WERE AFFECTED WERE NOT PROVIDED HOWEVER FURTHER INFORMATION WERE NOW PROVIDED THAT THE FOLLOWING PARTS WERE USED DURING THE INITIAL SURGERY 2015: AR-9120-01, LOT: 140113110. AR-9145-30, LOT: 140123108. AR-9504S-04, LOT: 2501212801. AR 9165-15, LOT: 140103207. AR-9145-30, LOT: 2501417704. AR-9502-36CPC, LOT: 140120310. AR -9501-07CPC, LOT: 2501215303. AR-9503S-03, LOT: 140104307. AR-9555-15, LOT:2501215101. AR-7213, LOT: 12812. AR-7200, LOT: 12795. HOWEVER IT COULD NOT BE CONFIRMED WHICH DEVICE HAS LED TO THE REPORTED ISSUE AND IF THE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: Skin Discoloration; Toxicity

  MAUDE report 10746425 ↗
• InjuryOct 28, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT DUE TO A METALLOSIS THE SHOULDER AND THE ARM OF THE PATIENT TURNED BLACK. THE SURGERY WHICH LED TO THE REPORTED EVENT WAS A SHOULDER PROSTHESIS WHICH WAS PERFORMED ON (B)(6) 2015. ACCORDING TO THE CUSTOMER ARTHREX DEVICES WERE IMPLANTED DURING THE INITIAL SURGERY IN 2015. CURRENTLY IT IS NOT KNOWN IN WHICH HOSPITAL THE INITIAL SURGERY TOOK PLACE. THEREFORE NO FURTHER INFORMATION ABOUT THE DETAILED INCIDENT AND THE USED ARTHREX PART NUMBERS ARE CURRENTLY AVAILABLE. UPDATE 12-OCT-2020: INITIALLY THE LOT NUMBERS WHICH WERE AFFECTED WERE NOT PROVIDED HOWEVER FURTHER INFORMATION WERE NOW PROVIDED THAT THE FOLLOWING PARTS WERE USED DURING THE INITIAL SURGERY 2015: AR-9120-01, LOT: 140113110, AR-9145-30, LOT: 140123108, AR-9504S-04, LOT: 2501212801, AR 9165-15, LOT: 140103207, AR-9145-30, LOT: 2501417704, AR-9502-36CPC, LOT: 140120310, AR -9501-07CPC, LOT: 2501215303, AR-9503S-03, LOT: 140104307, AR-9555-15, LOT:2501215101, AR-7213, LOT: 12812, AR-7200, LOT: 12795. HOWEVER IT COULD NOT BE CONFIRMED WHICH DEVICE HAS LED TO THE REPORTED ISSUE AND IF THE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: Skin Discoloration; Toxicity

  MAUDE report 10746387 ↗
• InjurySep 2, 2020Break; Corroded; Unstable; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL REVISION SURGERY ON 1/24/18 DURING WHICH THE FOLLOWING DEVICES WERE IMPLANTED: AR-9120-01 (LOT 170115215), AR-9145-36 (LOT 170037012), AR-9145-30 (LOT 170057712), AR-9504S-04 (LOT 170091414), AR-9555-09 (LOT 2501367202), AR-9503S-03C (LOT 2501374603), AR-9165-25 (LOT 2501357504). THE (B)(6) 2018 PROCEDURE WAS A REVISION OF ARTHREX PRODUCTS BECAUSE THE PATIENT HAD GLENOID INSTABILITY DUE TO BASEPLATE PLACEMENT ON THE PRIMARY. IT IS UNKNOWN IF THE 2018 REVISION WAS EVER REPORTED TO ARTHREX AS NO DETAILS FROM THE ORIGINAL SURGERY ARE KNOWN TO SEARCH/MATCH PART NUMBERS. THE IMPLANTS PUT IN ON (B)(6) 2018 WERE DONE SO IN A COMPROMISED GLENOID WITH POOR BONE QUALITY. THE PERIPHERAL SCREWS BROKE AND LED TO BASEPLATE FAILURE. THE GLENOSPHERE REMAINED ENGAGED IN THE BASEPLATE. THERE WAS SIGNIFICANT CORROSION OF THE HUMERAL POLY INSERT. THE GLENOID COMPONENTS FAILED NEARLY TWO YEARS AGO BUT THE PATIENT WAITED UNTIL (B)(6) 2020 TO HAVE A REVISION SURGERY. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON ATTRIBUTED THE FAILURE TO PUTTING THE BASEPLATE ON HER ORIGINAL REVERSE PROCEDURE TOO SUPERIOR ON THE FACE OF THE GLENOID WITH SIGNI

  Patient problems: No Code Available

  MAUDE report 10482773 ↗
• InjuryJul 22, 2020Break

  IT WAS REPORTED, THAT DURING A REVERSE TOTAL SHOULDER PROCEDURE, THE HEAD OF THE AR-9145-30, LOT: 18.01718 SCREW BROKE SCREW WHILE INSERTING INTO THE BASEPLATE. USING THE SCREW DRIVER AR-9545-T15-02 WITHOUT THE TORQUE LIMITER THE SCREW WAS FULLY SEATED BEFORE IT BROKE. THE HEAD OF THE SCREW WAS REMOVED AND THE REMAINING PORTION OF THE SCREW STAYED IN THE PATIENT. THE BASEPLATE AND SCREW WERE LEFT IN THE PATIENT AND THE CASE WAS COMPLETED AS DESIRED FIXATION WAS ACHIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10309742 ↗
• InjuryJul 15, 2020Break

  IT WAS REPORTED THAT TWO PERIPHERAL SCREWS OF THE PROSTHESIS BROKE POST OP. IT WAS FURTHER REPORTED THAT THE BREAKA GE WAS NOT THE RESULT OF A TRAUMA. INITIAL SURGERY WAS AN INVERSE SHOULDER PROSTHESIS, PERFORMED ON (B)(6) 2019. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. ALL FRAGMENTS HAVE BEEN REMOVED DURING THE REVISION SURGERY. DURING THE REVISION, A SPACER WAS IMPLANTED. NO FURTHER INFORMATION RECEIVED. UPDATE 29-JUNE-2020: THE CENTRAL SCREW WAS INTACT. BATCH NUMBERS WERE PROVIDED. THE DEVICE BREAKAGE WAS DISCOVERED BY X-RAY. ALL AVAILABLE X-RAYS HAVE BEEN PROVIDED TO ARTHREX. PATIENT HAD REPORTED TO THE SURGEON THAT POST OP AFTERCARE INSTRUCTIONS WERE FOLLOWED. BECAUSE OF AN INFECTION, A CEMENT SPACER WAS IMPLANTED. IT IS EXPECTED THAT THE TOTAL PROSTHETICS WILL BE RETURNED.

  Patient problems: Failure of Implant; No Code Available; Unspecified Infection

  MAUDE report 10279369 ↗
• InjuryFeb 3, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT WAS ORIGINALLY OPERATED ON USING THE ARTHREX REVERSE SHOULDER ON (B)(6) 2018. THE PATIENT ORIGINALLY HAD A SMALL BASEPLATE, 36 +4 GLENOSPHERE, SIZE 8 STEM, PLUS 6 SPACER, 20 CENTRAL SCREW, 2- 30MM PERIPHERAL SCREWS AND A PLUS 3 POLY INSERT IMPLANTED. IN (B)(6) 2019, THE PATIENT CAME TO THE SURGEON'S OFFICE COMPLAINING OF PAIN AND LACK OF MOTION. THE DECIDED TO REVISE THE PATIENT. THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2019. THE REP REPORTED DURING THE REVISION PROCEDURE, IT WAS CLEARLY OBVIOUS THAT THE BASEPLATE AND SCREWS HAD PULLED OUT OF THE FACE OF THE GLENOID. THE SURGEON REMOVED THE POLY, SPACER, BASEPLATE, SCREWS AND GLENOSPHERE, AND IMPLANTED AN AUGMENTED EXACTTECH GLENOID IMPLANT AND GLENOSPHERE. ONCE THAT WAS COMPLETED, THE SURGEON IMPLANTED A PLUS 12 ARTHREX SPACER AND A PLUS 3 POLY LINER ONTO THE EXISTING SIZE 8 STEM AND 36 CUP. THE IMPLANTS WENT IN WITHOUT ANY PROBLEM AND THE SURGEON WAS VERY PLEASED WITH THE POST OPERATIVE RESULTS. THE SURGEON CHOSE TO KEEP THE IMPLANTS THAT WERE EXTRACTED AND EXPECTS THE PATIENT TO DO WELL. ADDITIONAL INFORMATION RECEIVED ON 01/06/2020: THE REP REPORTED THEY DO NOT HAVE ACCESS TO THE PART OR LOT NU

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9659040 ↗
• InjuryMar 21, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TSA PROCEDURE ON (B)(6) 2018. 9 MONTHS POST-OP, ON (B)(6) 2019, THE PATIENT WAS SEEN BY THEIR SURGEON FOR A FOLLOW-UP VISIT WHERE AN X-RAY WAS TAKEN TO DETERMINE PROGRESS. THE X-RAY SHOWED THAT THE BASEPLATE AND GLENOSPHERE WERE DISLOCATED. THE PATIENT STATED THAT NO TRAUMA HAD OCCURRED. A COPY OF THE X-RAY IS UNABLE TO BE OBTAINED. A REVISION SURGERY TOOK PLACE ON 2/19/2019 AND THE FOLLOWING DEVICES WERE ALL EXPLANTED: AR-9145-30 / LOT: 170156313, AR-9145-36 / LOT: 170139313, AR-9504M / LOT: 140119609, AR-9503M-06 / LOT: 160010109, AR-9120-01 / LOT: 170145515, AND AR-9165-20 / LOT: 150008108. THE SURGEON SWITCHED TO AN RTSA AND IMPLANTED THE FOLLOWING: AR-9502-39ARCA / LOT: 261519 AND AR-9550-19RCA / LOT: 10031668. ADDITIONAL INFORMATION PROVIDED 3/29/2019: THE AR-9145-30 SCREW BROKE UPON REMOVAL OF HARDWARE. TIP WAS RETRIEVED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8440349 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A NURSE AT AN ALLERGIST'S OFFICE THAT A PATIENT HAD RIGHT SHOULDER-REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2017. DURING THE SURGERY THE FOLLOWING PRODUCTS (LOT NUMBERS UNKNOWN) WERE IMPLANTED IN THE PATIENT: AR-9501-06P UNIVERSAL REVERSE HUMERAL STEM, AR-9502-36RCPC UNIVERSAL REVERSE CUP, AR-9145-30 UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW (QTY UNKNOWN), AND AR-9120-01 UNIVERSAL GLENOID BASEPLATE SMALL. IT HAS BEEN REPORTED THAT PATIENT BEGAN HAVING REACTION TYPE SYMPTOMS, LOW GRADE TEMPERATURE - PAIN - RASH, ALMOST IMMEDIATELY AFTER THE PROCEDURE WHICH HAS PERSISTED. NO CULTURES HAVE BEEN TAKEN; HOWEVER BLOOD WORK TAKEN SHOWED NO INFECTION INDICATED. PATIENT IS BEING SEEN BY AN ALLERGIST TO ATTEMPT TO DETERMINE IF PATIENT MAY HAVE AN ALLERGY TO THE ARTHREX IMPLANTS. MATERIAL COMPOSITION OF THE PRODUCTS HAS BEEN PROVIDED TO THE REPORTER.

  Patient problems: Fever; Pain; Rash

  MAUDE report 7901945 ↗
• InjuryDec 16, 2016Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A CONTROL EXAMINATION ON (B)(6) 2016, AFTER IMPLANTATION ON (B)(6) 2016, IT WAS RECOGNIZED THAT THE BASEPLATE HAD BECOME LOOSE. UNDER X-RAY, A BREAKAGE OF THE LOCKING SCREW WAS DETECTED. A REVISION SURGERY WAS DONE TO REMOVE THE BROKEN SCREW AND REPAIR THE DEFECT.

  Patient problems: Failure of Implant

  MAUDE report 6180333 ↗