Arthrex® AR-9343-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867060005), received between Aug 26, 2019 and Sep 20, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Break; Break

  UPDATE DW 24-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE CUSTOMER HAS REMOVED THE GLENOID ARTHROSCOPIC. IT WAS THEN FURTHER REPORTED THAT DUE TO AN OMARTHROSE AN ADDITIONAL SURGERY WAS PERFORMED AND AN INVERSE SHOULDER-TEP WAS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20266283 ↗
• MalfunctionSep 19, 2024Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY OF AN ARTHREX PEGGED GLENOID WAS NECESSARY ON (B)(6) 2018 AFTER AN IMPLANTATION ON (B)(6) 2018 DUE TO A ROTATOR CUFF RUPTURE WITH GLENOID LOOSENING. THE PROSTHESIS WAS EXCHANGED TO AN INVERS PROSTHESIS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Aseptic loosening; Failure of Implant; Rupture

  MAUDE report 20258547 ↗
• 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 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 A 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 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 INFORMATION

  Patient problems: Pain

  MAUDE report 18439574 ↗
• InjuryNov 16, 2020Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT LOOSENING AND BREAKAGE OF THE GLENOID COMPONENT DUE TO PE ABRASION OCCURRED. REVISION SURGERY PERFORMED WITH PROSTHESIS REMOVAL, IMPLANTATION OF AN INVERSE SHOULDER PROSTHESIS ON THE RIGHT FROM A DIFFERENT MANUFACTURER. INTRAOPERATIVELY, DEFECT OF THE GLENOID WAS CONFIRMED. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2013, DATE OF REVISION SURGERY WAS (B)(6) 2020. MALE PATIENT, YOB: (B)(6). NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. ADDITIONAL INFORMATION OBTAINED ON 13-JUL-2020: THE PATIENT SUFFERED FROM PAIN AND WENT TO THE HOSPITAL, NO KNOWN TRAUMA THAT COULD HAVE CAUSED THE PAIN. PATIENT DOES NOT HAVE AN EXTRAORDINARILY HIGH BMI OR ANY KNOWN EXTRAORDINARILY STRESS. ADDITIONAL INFORMATION OBTAINED ON 27-OCT-2020: THE PART NUMBERS OF THE EXPLANTED ARTHREX DEVICES HAS BEEN PROVIDED, AND ARE AS FOLLOWS: AR-9105-01 W/ BATCH 1221011; AR-9343-16 W/ BATCH 1295122004; AR-9300-43CPC W/ BATCH 12.055; AR-9301-02 W/ BATCH 12.363.

  Patient problems: Abrasion; Pain

  MAUDE report 10842523 ↗
• MalfunctionNov 4, 2020Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PEG GLENOID AR-9105-02 BECAME LOOSE THROUGH ABRASION. THE FOLLOWING COMPONENTS ARE INVOLVED. AR-9102-02 W. BATCH UNK; AR-9300-43CPC W. BATCH 12315; AR-9301-02 W. BATCH 12537; AR-9343-16 W. BATCH 11295131006. DEVICES WILL BE RETURNED FOR INVESTIGATION, THEREFORE, REVISION SURGERY HAS BEEN PERFORMED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Abrasion

  MAUDE report 10786985 ↗
• InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY OF AN ARTHREX ECLIPSE SHOULDER PROSTHESIS TO AN INVERSE PROSTHESIS HAD BEEN PERFORMED. REASON OF THE REVISION WAS AN INSUFFICIENCY OF THE ECLIPSE PROSTHESIS AFTER SEVERAL ROTATOR CUFF REPAIR SURGERIES. NO LOOSENING OF THE ECLIPSE OR THE GLENOID WERE OBSERVED, NO LOOSENING OF THE IMPLANTS. ACCORDING TO THE REPORTER, THE PATIENT HAD NO PROBLEMS WHICH COULD BE ATTRIBUTED TO THE IMPLANTED ECLIPSE PROSTHESIS ONLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10333336 ↗
• InjuryAug 26, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT AN ORIGINAL SURGERY ON (B)(6) 2014 AND WAS PART OF AN (B)(6) STUDY PROGRAM (STUDY ID NUMBER IS (B)(6)). THE SURGEON HAS REPORTED THAT THE PATIENT HAD A DIAGNOSIS OF AN INFECTED CONTRALATERAL SHOULDER REPLACEMENT AND TWO HIP REPLACEMENTS THAT ARE INFECTED. ALL COMPONENTS WERE EXPLANTED ON (B)(6) 2019. AT THE SAME MEDICAL FACILITY, WITH THE SAME SURGEON. IN EARLY 2019 THE PATIENT HAD DEVELOPED AN ABSCESS. EXACT DATE OF ONSET OF PATIENT SYMPTOMS IS UNKNOWN AS THE PATIENT HAD BEEN ASPIRATED BY ANOTHER SURGEON PRIOR TO HIS INVOLVEMENT IN THE ISSUES RESULTING IN THE EXPLANT PROCEDURE. SURGEON SAW THE PATIENT IN (B)(6) OF 2019 FOR THE ISSUES. PATIENT WAS SCHEDULED FOR A RADICAL DEBRIDEMENT WITH ANTIBIOTIC SPACER AT THAT TIME, HOWEVER THAT PROCEDURE HAD TO BE CANCELLED DUE TO MEDICAL REASONS. PATIENT WAS ADMITTED TO THE MEDICAL FACILITY LAST WEEK DUE TO MULTIPLE JOINT INFECTIONS AND WAS CLEARED FOR THE PROCEDURE TO REMOVE ALL COMPONENTS. AN ANTIBIOTIC SPACER WAS IMPLANTED. THE SURGEON REPORTS FINDING NO ISSUES WITH THE DEVICES AT ALL. HE DID NOTE THAT THE GLENOID WAS LOOSE, MOST LIKELY FROM CHRONIC INFECTION. SURGEON STATED THAT THE ECLIPSE COM

  Patient problems: Abscess; Bacterial Infection

  MAUDE report 8930994 ↗