REUNION 5573-C-3602Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327098884), received between Jun 6, 2018 and Mar 31, 2021 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "THE PATIENT ARRIVED IN DR'S OFFICE FOR A POST-OP FOLLOW-UP VISIT WITH LEFT SHOULDER PAIN. UPON REVIEWING THE X-RAY IT WAS EVIDENT THE GLENOSPHERE HAD DISSOCIATED REQUIRING A REVISION PROCEDURE."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 11600204 ↗
• MalfunctionMay 5, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  PRIMARY PROCEDURE, RIGHT REVERSE SHOULDER. IT WAS REPORTED THAT UPON OPENING THE GLENOSPHERE, THE IMPACTOR WOULD NOT INSERT INTO THE IMPLANT DUE TO FOREIGN MATTER IN THE SCREW HOLE OF THE IMPLANT. A SECOND IMPLANT OF A DIFFERENT SIZE WAS AVAILABLE AND USED INSTEAD TO COMPLETE THE SURGERY SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 3-4 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10026911 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "[SURGEON] REPORTS PATIENT [PATIENT NAME], A STATUS POST RIGHT REVERSE SHOULDER REPLACEMENT DONE APPROXIMATELY 2 MONTHS AGO NOW CAME INTO THE OFFICE WITH A DRAINING OPEN SORE AT THE INCISION SITE. [SURGEON] DECIDED TO WASH OUT AND REVISE THE SHOULDER IMPLANTS. ALL IMPLANTS WERE CAREFULLY REMOVED EXCEPT THE HUMERAL STEM WHICH WAS WELL FIXED. THE SHOULDER WASHED OUT EXTENSIVELY AND A NEW SET OF IMPLANTS WERE REPLACED (BASEPLATE, GLENOSPHERE, SCREW, TRAY AND INSERT). SURGERY WAS PERFORMED WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE DUE TO EMR PASSWORD SECURED."

  Patient problems: Fluid Discharge; Injury

  MAUDE report 9993335 ↗
• InjuryFeb 21, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S REVERSE SHOULDER WAS REVISED AFTER PATIENT DISLOCATED. THE SURGEON DECIDED THE JOINT WAS NOT TIGHT ENOUGH AND INCREASED THE SIZE OF THE POLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8359172 ↗
• InjuryOct 19, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT'S LEFT REVERSE SHOULDER WAS REVISED DUE TO A LOOSE GLENOSPHERE. NO TRAUMA WAS REPORTED. SURGEON REPORTED SUSPICION THAT THE GLENOSPHERE MAY NOT HAVE BEEN FULLY SEATED AT IMPLANTATION.

  Patient problems: Discomfort

  MAUDE report 7986133 ↗
• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS A RESULT OF A SHOULDER INJURY IN (B)(6) 2015, PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY USING A STRYKER REUNION RSA. THE RECOVERY WENT WELL, AND THE PATIENT HAD AN ACCEPTABLE ROM DESPITE SOME HO ON THE TOP OF THE HUMERUS. AT THE END OF 2016 PATIENT STARTED TO EXPERIENCE PERIODS OF DISCOMFORT. EVENT 1 OF 3. AS REPORTED BY THE PATIENT¿ AT THE END OF 2016, I STARTED EXPERIENCE PERIODS OF DISCOMFORT AND IN EARLY (B)(6) A SPIDER-WEB LOOKING RASH APPEARED AROUND THE UPPER INCISION AREA. THEN AT THE END OF (B)(6) A ¼ INCH DIAMETER, FLUID FILLED CYST APPEARED AT THE UPPER END OF THE INCISION. AFTER 7 ¿ 10 DAYS THE CYST DRIED UP LEAVING A DEPRESSION, BUT THE RASH REMAINED. TWO WEEKS LATER, THE CYST REAPPEARED IN THE SAME SPOT BUT WAS NOW ½ INCH IN DIAMETER. IT AGAIN DRIED UP OVER THE NEXT 7 ¿ 10 DAYS LEAVING A LARGER DEPRESSION. TWO WEEKS LATER THE CYST REAPPEARED, THIS TIME ABOUT ¾ INCH IN DIAMETER. PATIENT MADE AN APPOINTMENT WITH HIS SURGEON WHO, IN HIS YEARS OF EXPERIENCE, HAD NEVER SEEN CYST LIKE THIS ASSOCIATE WITH AN INCISION. AFTER A BLOOD TEST PROVED NEGATIVE FOR INFECTION, HE RECOMMENDED EXPLORATORY SURGERY WHICH WAS UNDERTAKEN ON (B)(6) 2017.¿ ADVERSE CONSEQUENCE

  Patient problems: Discomfort; Rash

  MAUDE report 7577731 ↗
• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS A RESULT OF A SHOULDER INJURY IN (B)(6) 2015, PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY USING A STRYKER REUNION RSA. THE RECOVERY WENT WELL, AND THE PATIENT HAD AN ACCEPTABLE ROM DESPITE SOME HO ON THE TOP OF THE HUMERUS. AT THE END OF 2016 PATIENT STARTED TO EXPERIENCE PERIODS OF DISCOMFORT. EVENT 2 OF 3. AS REPORTED BY THE PATIENT: SINCE THAT TIME, THE CYST HAS NOT RETURNED; HOWEVER, LEVEL OF DISCOMFORT HAS INCREASED, AND MY ROM HAS GRADUALLY DECREASED. THE RASH HAS PERSISTED FOR THE LAST YEAR AND APPEARS TO BE DYNAMIC ¿ IT FADES SLIGHTLY WHEN I AM LESS ACTIVE (OVERNIGHT) AND INTENSIFIES WHEN I AM ACTIVE. THE RASH APPEARS AS A FLOW OF RED LINES EMANATING FROM THE SITE OF THE CYST. IN (B)(6) 2007, I MADE AN APPOINTMENT WITH AN ALLERGIST WHO PERFORMED A STANDARD PATCH TEST. IT SHOWED THAT I HAD AN ALLERGY TO NICKEL, BUT NOT TO TITANIUM, ZIRCONIUM, COBALT AND CHROMIUM. I UNDERSTAND THAT THE STRYKER UNIT CONSISTS OF THREE DIFFERENT METALS: THREE PARTS MADE OF COBALT/CHROMIUM ALLOY, ONE PART MADE OF TITANIUM/ALUMINUM/VANADIUM ALLOY, AND ONE PART MADE OF PURE TITANIUM.

  Patient problems: Discomfort; Rash

  MAUDE report 7577725 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS A RESULT OF A SHOULDER INJURY IN (B)(6) 2015, PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY USING A STRYKER REUNION RSA. THE RECOVERY WENT WELL, AND THE PATIENT HAD AN ACCEPTABLE ROM DESPITE SOME HO ON THE TOP OF THE HUMERUS. AT THE END OF 2016 PATIENT STARTED TO EXPERIENCE PERIODS OF DISCOMFORT. EVENT 3 OF 3: AS REPORTED BY THE PATIENT¿ A SERUM TEST IN (B)(6) FOR COBALT AND CHROMIUM INDICATED A SLIGHT ABOVE NORMAL LEVEL OF COBALT (BUT LESS THAN 1 PPB). DURING MY SIX-MONTH SURGERY FOLLOW UP (B)(6) 2018, ALL BLOOD TESTS WERE NORMAL, AND THE X-RAYS SHOWED NOTHING ABNORMAL. THE SURGEON WAS STILL BAFFLED BY THE RASH AND SUGGESTED THAT THE PATIENT GETS IN TOUCH WITH A DERMATOLOGIST TO SEE IF A BIOPSY MIGHT REVEAL SOMETHING. THE BIOPSY RESULTS WERE AS FOLLOWS: SPARSE PERIVASCULAR AND INTERSTITIAL DERMATITIS, WITH HISTIOCYTES, MAST CELLS, AND SCATTERED EOSINOPHILS. THE DERMATOLOGIST PRESCRIBED TREATMENT WITH CLOBETASOL PROPIONATE, BUT THAT SEEMED TO INTENSIFY THE RASH.¿

  Patient problems: Discomfort; Rash

  MAUDE report 7575893 ↗