Arthrex® AR-9144-17PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867057692), received between Jun 22, 2017 and Dec 7, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT TOTAL JOINT REPLACEMENT IN HER SHOULDERS IN 2009 AND 2010. PATIENT IS CURRENTLY UNDER CARE FOR SYSTEMIC SCLEROSIS AND HAS BLOODWORK DONE EVERY 6 MONTHS. THE COBALT/CHROMIUM LEVEL IN HER BLOOD IS INCREASING. AT TIME OF INITIAL REPORT PART NUMBERS WERE NOT PROVIDED BUT HAVE BEEN REQUESTED. ADDITIONAL INFORMATION OBTAINED 11/17/20: THE PATIENT UNDERWENT RIGHT SHOULDER SURGERY (B)(6) 2009. PATIENT ALSO HAD LEFT SHOULDER SURGERY (B)(6) 2010 APPROXIMATELY ONE YEAR LATER THE PATIENT HAD A REVISION SURGERY ON THE LEFT SHOULDER BOTH THE (B)(6) 2010 SURGERY AND THE REVISION OF THAT SURGERY WERE DONE BY THE SAME SURGEON/FACILITY AS THE 2009 PROCEDURE. PATIENT IS UNSURE WHAT THE REVISION SURGERY ACTUALLY ENTAILED. PATIENT IS SEEING A RHEUMATOLOGIST FOR HER SYSTEMIC SCLEROSIS AND IT HAS BEEN DISCOVERED THAT SHE HAS COBALT IN HER BLOOD. PATIENT WAS REFERRED TO HER PRIOR HIP REPLACEMENT SURGEON (DIFFERENT THAN SHOULDER SURGEON).. MRI'S WEE PERFORMED AND SHOWED NO COMPROMISE. PATIENT BELIEVES THIS WAS PERFORMED APPROXIMATELY (B)(6) 2019. AT THIS TIME THEY DO NOT BELIEVE THAT ANY OF HER CURRENT HEALTH ISSUE ARE DUE TO THE COBALT ISSUE. THE CONCERN I

  Patient problems: Toxicity

  MAUDE report 10962181 ↗
• InjuryAug 14, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TRUNNION OF THE AR-9100-06P UNIVERS II STEM (SIZE 6) WOULD NOT REMAIN ENGAGED WITH THE PROXIMAL STEM BODY TO FACILITATE STEM EXTRACTION DURING A TSA REVISION TO RSA PROCEDURE. AFTER SEVERAL ATTEMPTS TO RE-ENGAGE, THE TRUNNION WOULD STILL NOT ENGAGE. A SEPARATE STEM AR-9100-13P (LOT:16.00283) WAS OPENED AND THAT TRUNNION WAS USED TO SUCCESSFULLY EXTRACT THE STEM FROM THE PATIENT WITHOUT FURTHER PROBLEMS. THE COMPLAINT DEVICE WILL BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 07/29/2019: THE REP STATED THE REVISION PROCEDURE WAS DUE TO THE PATIENT FALLING AND TEARING THEIR SUBSCAPULARIS. THE SURGEON DETERMINED A REVISION WAS THE BEST PLAN OF ACTION. PRIOR TO THE REVISION PROCEDURE TAKING PLACE THE PATIENT WAS EXPERIENCING DISCOMFORT DUE TO CHRONICALLY DISLOCATING THEIR SHOULDER AS A RESULT OF THE TORN ROTATOR CUFF. THE REP STATED THE DATE OF THE FALL IS UNKNOWN. THE PRIMARY ANATOMIC TSA PROCEDURE TOOK PLACE IN (B)(6) 2018, AND WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE REVISION AND TOOK PLACE AT THE SAME FACILITY. THE BONE QUALITY WAS MEDIUM. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE, AND EXPLANTED DURI

  Patient problems: Discomfort; Fall; Joint Dislocation

  MAUDE report 8893669 ↗
• InjuryJun 22, 2017Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2014. IN (B)(6) 2014, THE PATIENT BEGAN TO EXPERIENCE LAXITY IN THE SHOULDER. ON (B)(6) 2017, A REVISION REVERS TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED WHERE THE PREVIOUSLY IMPLANTED UNIVERS APEX 6 MM HUMERAL STEM (AR-9100-06S, LOT: 974810, LINE 195553), SMALL GLENOID W/ PEG (AR-9105-01, LOT: 1329015, LINE 195554) AND USP II HUMERAL HEAD (AR-9144-17P, LOT: 2501356510, LINE 195555) WERE EXPLANTED AND REPLACED WITH ARTHREX REVERS TOTAL SHOULDER PARTS.

  Patient problems: No Code Available

  MAUDE report 6661161 ↗