REUNION 5569-P-2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327098143), received between May 23, 2018 and Feb 1, 2022 — classified as 7 injuries.

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

• InjuryFeb 1, 2022Unstable; Unstable

  AS REPORTED: "SHOULDER INSTABILITY. THE SURGEON REPLACED THE SHOULDER STEM AND HUMERAL CUP AND INSERT." REVISION SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419038 ↗
• InjuryMar 21, 2019Microbial Contamination of Device

  IT WAS REPORTED THAT A STAGE 1 REVISION OF THE PATIENT'S LEFT SHOULDER WAS PERFORMED DUE TO INFECTION. SURGEON REPORTED INFECTION AS MRSA. PATIENT'S ENTIRE SHOULDER CONSTRUCT WAS REMOVED AND A SPACER WAS PLACED. REP REPORTED THAT THE HOSPITAL AND SURGEON WILL NOT RELEASE ANY FURTHER INFORMATION.

  Patient problems: Bacterial Infection

  MAUDE report 8441693 ↗
• InjuryAug 7, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S LEFT SHOULDER WAS REVISED DUE TO THE HUMERAL HEAD BECOMING DISASSOCIATED FROM THE STEM. THE STEM WAS REPORTED TO HAVE COUNTER-SUNK INTO THE PATIENT'S HUMERUS. THE SURGEON STATED THAT NO TRAUMA (FALL, ETC) HAD BEEN REPORTED BY THE PATIENT. PATIENT WAS REVISED TO A LARGER STEM AND SAME-SIZED HUMERAL HEAD.

  Patient problems: Failure of Implant

  MAUDE report 7756242 ↗
• 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 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 CONSEQUENCES

  Patient problems: Discomfort; Rash

  MAUDE report 7575894 ↗
• 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 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 (B)(4), ONE PART MADE OF (B)(4), AND ONE PART MADE OF (B)(4).

  Patient problems: Discomfort; Rash

  MAUDE report 7575849 ↗
• 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 7575844 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON PATIENT'S LEFT SHOULDER DUE TO INFECTION (REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED, UNKNOWN IF INFECTING MICROORGANISM WAS IDENTIFIED). REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 7539089 ↗