Arthrex® AR-9106-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867239319), received between Mar 15, 2018 and Mar 24, 2026 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Patient Device Interaction Problem

  ON 04-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A PATIENT UNDERWENT A REVISION FROM ECLIPSE + VAULTLOCK TSA TO RTSA ON (B)(6) 2026. THE PATIENT¿S ORIGINAL SURGERY DATE WAS ON (B)(6) 2024. THE REVISION WAS PERFORMED DUE TO SUBSCAPULARIS FAILURE AND NOT DUE TO FAILURE OF THE ECLIPSE OR VAULTLOCK IMPLANTS. HOWEVER, SIGNIFICANT VAULTLOCK EROSION WAS NOTED AT LESS THAN TWO YEARS POST-IMPLANTATION. THE ARTHREX IMPLANTS EXPLANTED DURING THE REVISION INCLUDED: AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, SMALL, AR-9301-02 ARTHREX ECLIPSE CAGE SCREW MEDIUM (35.0 MM), AR-9301-39CPC ARTHREX ECLIPSE TRUNION 39 MM, SLOTTED, TPS CAP, AND AN AR-9339-18 ARTHREX ECLIPSE HUMERAL HEAD, 39/18. ADDITIONAL INFORMATION WAS RECEIVED ON 10-MAR-2026: THE PATIENT WAS INITIALLY TREATED ON (B)(6) 2024 FOR A SUBSCAPULARIS TEAR SUSTAINED DURING A PHYSICAL ALTERCATION. DURING THE REVISION, ANTERIOR EROSION MEASURING APPROXIMATELY 2¿3 MM WAS OBSERVED. THE SURGEON DID NOT COMMENT ON WHETHER THE EROSION CONTRIBUTED TO THE NEED FOR REVISION OR IF IT WAS AN INCIDENTAL FINDING. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CASE DELAY AND NO ADDITIONAL ANESTHESIA REPORTED. NO FURTHER SURGERIE

  Patient problems: Erosion; Insufficient Information

  MAUDE report 24673505 ↗
• MalfunctionFeb 7, 2025Break; Break

  ON 1/15/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A PATIENT REPORTED HAVING AN ARTHREX SHOULDER REPLACEMENT SURGERY ABOUT FOUR YEARS AGO. THE PATIENT REPORTED WORSENING SYMPTOMS AFTER THE SURGERY ON (B)(6) 2020. LESS THAN FOUR YEARS AFTER THE INITIAL SURGERY, THE PATIENT UNDERWENT REVISION SURGERY TO A REVERS TOTAL SHOULDER REPLACEMENT. THE PATIENT REPORTED THAT DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE GLENOHUMERAL COMPONENT WAS DAMAGED, AND ONE OF THE PEGS WAS SHEERED COMPLETELY OFF, CAUSING PAIN, SWELLING, AND PIOUS AMOUNTS OF FLUID BUILDUP. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED ON 1/23/2025. ADDITIONAL INFORMATION RECEIVED ON 1/23/025: DURING THE INITIAL SURGERY ON (B)(6) 2020, AN AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, AN AR-9301-02 ARTHREX ECLIPSE CAGE SCREW, AND AN AR-9301-43CPC ARTHREX ECLIPSE TRUNION WERE IMPLANTED. THE PATIENT STARTED TO EXPERIENCE PAIN AND SOUGHT OUT MEDICAL TREATMENT. THE PATIENT UNDERWENT TWO DEBRIDEMENT PROCEDURES, IN WHICH THE MISSING PEG WAS DISCOVERED. THE THIRD PROCEDURE WAS THE REVERS TOTAL SHOULDER REPLACEMENT WHICH OCCURRED ON (B)(6) 2024.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21337010 ↗
• MalfunctionJun 5, 2024Break; Break

  ON 05/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9106-01 ARTHREX® UNIVERS VAULTLOCK¿ GLENOID BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19468296 ↗
• MalfunctionJun 3, 2024Break; Break

  ON 05/06/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9106-01 ARTHREX® UNIVERS VAULTLOCK¿ GLENOID BROKE. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19446277 ↗
• InjuryMay 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INITIAL SHOULDER PROSTHESIS SURGERY 2020 THE PATIENT NOW EXPERIENCED PAIN SINCE SEVERAL MONTHS. UPDATE DW 25-APR-2024: FURTHER INFORMATION WERE PROVIDED THAT NO SPECIFIC DEVICE MALFUNCTION WAS IDENTIFIED. THE PATIENT SUFFERS FROM PAINT AND NUMBNESS IN THE SIDE OF THE UPPER ARM. THE PATIENT FURTHER PROVIDED THE INFORMATION THAT THE INITIAL SURGERY WAS PERFORMED IN MÜNSTER BUT DID NOT PROVIDE THE NAME OF THE HOSPITAL WHERE SHE WAS TREATED. SHE FURTHER REPORTED THAT THE SHE FEELS THE PAIN SINCE HALF A YEAR AND DID NOT EXPERIENCE ANY ISSUES BEFORE.

  Patient problems: Pain

  MAUDE report 19259039 ↗
• MalfunctionJan 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON JULY 11, 2022, A NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT, LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY, IS EXPERIENCING WORSENING PAIN. AN X-RAY SHOWS A DISLODGED GLENOID COMPONENT. SURGEON HAS SCHEDULED THE PATIENT FOR A REVISION SURGERY TO AN RSA ON (B)(6) 2022. ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED ON 7/12/2022: DURING SURGERY ON (B)(6) 2020, A TOTAL OF (B)(4) ARTHREX DEVICES WERE IMPLANTED. AN AR-9301-03 ECLIPSE CAGE SCREW LARGE, LOT NUMBER 19.00501, AN AR-9301-43CPC ECLIPSE TRUNION, LOT NUMBER 18-01245, AN AR-9343-16 ECLIPSE HUMERAL HEAD, LOT NUMBER 1917001, AND AN AR-9106-01 UNIVERS VAULTLOCK GLENOID. AS OF NOW, NOTHING HAS SHOWN TO BE BROKEN INSIDE THE PATIENT BUT THERE'S AS DISLODGMENT OF GLENOID PROSTHESIS. ADDITIONAL INFORMATION RECEIVED ON 7/25/2022: ACCORDING TO FACILITY REPRESENTATIVE, PATIENT EXPERIENCED CARDIAC EVENTS DURING THE PRE-OP AREA AND REVISION SURGERY DID NOT TAKE PLACE. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT WILL UNDERGO REVISION SURGERY. ADDITIONAL INFORMATION RECEIVED ON 12/30/2022: THE REVISION SURGERY THAT WAS TO TAKE PLACE ON (B)(6) 2022, WAS CANCELLED DUE TO CARDIAC CO-MORBIDITIES. NO FURTHER I

  Patient problems: Pain

  MAUDE report 18439579 ↗
• InjuryJan 30, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Patient Device Interaction Problem

  ON JANUARY 9TH, 2023, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED OF A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY. PATIENT UNDERWENT TOTAL SHOULDER PROCEDURE ON (B)(6) 2021, IN WHICH THE ARTHREX UNIVERS APEX IMPLANT SET WAS USED. A YEAR LATER, PATIENT COMPLAINT OF PAIN AND MOTION LIMITATION. ON (B)(6), 2022, A REVISION TOOK PLACE FOR ARTHROSCOPIC DEBRIDEMENT AND NERVE RELEASE OF THE SUPRASCAPULAR NOTCH. NO ADDITIONAL INFORMATION HAS BEEN REPORTED AS OF NOW. ADDITIONAL INFORMATION RECEIVED ON 1/10/2023: THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE ORIGINAL PROCEDURE: ARTHREX UNIVERS LL HUMERAL HEAD, PART NUMBER AR-9140-17P, LOT170024021. ARTHREX UNIVERSE APEX HUMERAL STEM, PART NUMBER AR-9100-05S, LOT 10193799. UNIVERS VAULTLOCK GLENOID SMALL PART NUMBER AR-9106-01, LOT1027262023. ALL REMAIN IMPLANTED IN THE PATIENT, AS NOTHING WAS EXPLANTED DURING THE REVISION SURGERY. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY.

  Patient problems: Pain

  MAUDE report 16263461 ↗
• InjuryJan 23, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Patient Device Interaction Problem

  ON JANUARY 6TH, 2023, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED OF A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY. PATIENT UNDERWENT TOTAL SHOULDER PROCEDURE ON (B)(6) 2020, IN WHICH THE ARTHREX ECLIPSE IMPLANT SET WAS USED. A YEAR LATER, (B)(6) OF 2022, PATIENT PRESENTED PAIN AND CUFF DYSFUNCTION. A DECISION WAS MADE TO CONVERT THE ARTHROPLASTY PROCEDURE TO A REVERSE PROCEDURE ON (B)(6) 2022. THIS IS ALL THE INFORMATION PROVIDED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 1/10/2023: DURING THE ORIGINAL SURGERY ON (B)(6) 2020, THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: ARTHREX ECLIPSE HUMERAL HEAD SIZE 41X16MM, PART NUMBER AR-9341-16, LOT1911007. ARTHREX ECLIPSE CAGE SCREW MEDIUM, PART NUMBER AR-9301-02, LOT 18.01106. ARTHREX ECLIPSE TRUNION 39MM, PART NUMBER AR-9301-39CPC LOT 18.01134. ARTHREX UNIVERS VAULT LOCK GLENOID SMALL, PART NUMBER AR-9106-01, LOT 1027261912. DURING THE REVISION SURGERY, THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: ARTHREX UNIVERS VAULT LOCK GLENOID SMALL, PART NUMBER AR-9106-01, LOT 1027261912. ARTHREX ECLIPSE HUMERAL HEAD SIZE 41X16MM, PART NUMBER AR-9341-16, LO 1911007. ARTHREX ECLIPSE CAGE SCRE

  Patient problems: Failure of Implant; Pain

  MAUDE report 16223479 ↗
• MalfunctionMay 16, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9106-01 UNIVERS VAULTLOCK GLENOID'S CENTRAL FLUTE BROKE. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE PATIENT. PER FACILITY: "AFTER TAKING THE BONE SLURRY FROM THE HUMERAL HEAD CUT, WE WERE PLACING THE BONE GRAFT AROUND THE CENTRAL FLUTE OF THE VAULTLOCK WITH THE COMPRESSION TOOL. WHEN PULLING BACK WITH THE TOOL, TO KEEP THE BONE GRAFT ON THE FLUTE, HALF OF THE FLUTE PULLED OFF OF THE IMPLANT."

  Patient problems: Foreign Body In Patient

  MAUDE report 14407026 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT MAY HAVE HAD AN ISSUE AS A RESULT OF SURGERY INVOLVING ARTHREX IMPLANTS. UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT A PATIENT HAD A (B)(6) 2018, TOTAL SHOULDER ARTHROPLASTY PROCEDURE. ON (B)(6) 2018, A FEW DAYS POST SURGERY, THE PATIENT WAS EXPERIENCING INABILITY TO EXTEND FINGERS. THE PATIENT WAS DIAGNOSED WITH RADIAL NERVE PALSY. PATIENT WAS ABLE TO EXTEND WRIST ON (B)(6) 2019, BUT HAD DIFFICULTY TYPING. AN EMG WAS RECOMMENDED. PATIENT WAS TOLD NERVE PALSY WOULD RESOLVE WITHIN THE YEAR. THE PATIENT CONSULTED WITH AN ORTHOPEDIC HAND SURGERY SPECIALIST WHO SUGGESTED A TENDON TRANSFER FOR THE NERVE PALSY. IT IS UNKNOWN IF THE PATIENT HAS PROCEEDED WITH A SECOND SURGERY WITH ANOTHER SURGEON. THE PATIENT HAS HAD NO FURTHER SURGERIES WITH THE ORIGINAL SURGEON. THE FOLLOWING ARE THE ARTHREX PRODUCTS THAT WERE IMPLANTED ON (B)(6) 2018; AR-9100-06S / LOT: 10233337; AR-9106-01 / LOT: 1027261806; AR-9142-17P / LOT: 170097421.

  Patient problems: No Code Available

  MAUDE report 10763909 ↗
• InjuryApr 29, 2020Break

  IT WAS REPORTED DURING A REVISION TOTAL SHOULDER REPLACEMENT PROCEDURE THE AR-9145-36 UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW BROKE AT THE HEAD/ SHAFT JUNCTION UPON INSERTION. THE REP REPORTED THE SCREW HEAD WAS RETRIEVED, BUT THE SHAFT WAS RETAINED IN THE BONE. THE HEX SCREW DRIVER WAS USED TO INSERT THE SCREW. THE RETRIEVED BROKEN SCREW HEAD WILL BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 03/04/2020: THE REP REPORTED THE REASON FOR THE REVISION TSA WAS DUE TO A FAILED GLENOID COMPONENT. THE REP STATED THERE WERE NO ARTHREX DEVICES EXPLANTED DURING THE REVISION SURGERY, AND THE CASE WAS COMPLETED WELL AFTER THE MALFUNCTION WITH THE SCREW OCCURRED. ADDITIONAL INFORMATION RECEIVED ON 04/08/2020: IT HAS BEEN CONFIRMED THAT THE ORIGINAL STATEMENT THAT NO ARTHREX DEVICES WERE EXPLANTED DURING THE REVISION SURGERY WAS INCORRECT. THE PRIMARY APEX TOTAL SHOULDER PROCEDURE TOOK PLACE ON THE(B)(6) 2019. THE FOLLOWING PRODUCTS WERE IMPLANTED DURING THE PRIMARY TOTAL SHOULDER SURGERY ON (B)(6) 2019: AR-9100-05S / UNIVERS APEX HUMERAL STEM, 5MM / LOT: 10035663, AR-9106-01 / UNIVERS VAULTLOCK GLENOID SMALL / LOT: 1027261623, AR-

  Patient problems: No Code Available

  MAUDE report 10009158 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2017 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-9100-10S LOT: 10055062; AR-9106-01 LOT: 1027261611 AND AR-9146-20P LOT: 160051618. ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION TSA/GLENOID REVISION AND HUMERAL HEAD SIZE REDUCTION FOR AN UNKNOWN REASON AND THE FOLLOWING DEVICES WERE EXPLANTED: AR-9106-01 LOT: 1027261611 AND AR-9146-20P LOT: 160051618. THESE WERE REPLACED WITH: AR-9105-01 LOT: 113601629 AND AR-9144-19P LOT: 160047318.

  Patient problems: No Code Available

  MAUDE report 8209268 ↗
• InjurySep 24, 2018Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A REVERSE TSA PROCEDURE WHERE A UNIVERSAL APEX HUMERAL STEM, AR-9100-07S, LOT: 10127600; A USPII HUMERAL HEAD, AR-9146-20P, LOT: 250133268; AND A UNIVERSAL VAULTLOCK GLENOID, AR-9106-01, LOT: 1012679, WERE IMPLANTED. IN (B)(6) OF 2018, ABOUT 6 MONTHS POST-OP, THE PATIENT WAS COMPLAINING THAT HIS SHOULDER FELT LOOSE. AN X-RAY WAS TAKEN AND THE SURGEON DETERMINED THAT THE GLENOID HAD FAILED AND A REVISION SURGERY WOULD BE NEEDED. ON (B)(6) 2018, A REVISION RTSA PROCEDURE WAS PERFORMED WHERE ALL THREE OF THE IMPLANTED DEVICES WERE EXPLANTED AND REPLACED WITH AN ARTHREX RTSA SYSTEM. THE EXPLANTED HARDWARE WAS DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 7902547 ↗
• InjurySep 24, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A REVERS TSA PROCEDURE WHERE A UNIVERS APEX HUMERAL STEM, AR-9100-05S, LOT: 10036035; A USPII HUMERAL HEAD, AR-9142-17P, LOT: 150030015; AND A UNIVERS VAULTLOCK GLENOID, AR-9106-01, LOT: 1027261549, WERE IMPLANTED. IN (B)(6) 2018, ABOUT 1 YEAR POST-OP, THE PATIENT HAD A FOLLOW UP APPOINTMENT WITH HIS SURGEON TO SEE THE PROGRESS OF THE TSA. AN X-RAY WAS TAKEN AND THE SURGEON DETERMINED THAT THE GLENOID HAD FAILED AND A REVISION SURGERY WOULD BE NEEDED. ON (B)(6) 2018, A REVISION RTSA PROCEDURE WAS PERFORMED WHERE ALL THREE OF THE IMPLANTED DEVICES WERE EXPLANTED AND REPLACED WITH AN ARTHREX RTSA SYSTEM. THE EXPLANTED HARDWARE WAS DISCARDED.

  Patient problems: No Code Available

  MAUDE report 7902215 ↗
• InjuryMar 15, 2018Positioning Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN APEX SHOULDER PROCEDURE ON (B)(6) 2017 WHERE A SMALL GLENOID W/ CLEAT (LOT: 1027261608) WAS IMPLANTED INTO THE PATIENT'S RIGHT SHOULDER. THE PATIENT FELT THAT HER SHOULDER WASN'T FIRMLY FIXATED AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. DURING THE REVISION, THE SURGEON OPTED FOR A RTSA AND THE GLENOID WAS REPLACED WITH A SMALL GLENOID BASEPLATE AND 3 SCREWS. PATIENT IS A FEMALE, (B)(6).

  Patient problems: Failure of Implant

  MAUDE report 7341149 ↗