REUNION 5573-6528Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327098822), received between Jun 6, 2018 and Mar 25, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY ARE EXPERIENCING SORENESS AND PAIN. ADDITIONALLY, THE PATIENT WANTS TO KNOW IF THEIR IMPLANTS WERE PART OF ANY RECALL.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 18970006 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "A POST-MARKET CLINICAL EVALUATION OF THE REUNION REVERSE. SHOULDER ARTHROPLASTY (RSA) SYSTEM: SUBJECT 01-004R POSTOPERATIVE HETEROTOPIC OSSIFICATION, SYMPTOMATIC. SUPERIOR GLENOID HO, PATIENT WAS STRUGGLING WITH OCCASIONAL SORENESS/TIGHTNESS SUBJECT SENT BACK TO PHYSICAL THERAPY TO IMPROVE RANGE OF MOTION AND STIFFNESS"

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 18606736 ↗
• InjuryJan 3, 2024Break; Fracture; Osseointegration Problem; Break; Fracture; Osseointegration Problem

  AS REPORTED; "SURGEON SCHEDULED A REVISION SURGERY WITH THE STRYKER REPRESENTATIVE. DURING THE SURGERY, IT WAS DETERMINED THAT THE BASEPLATE/SCREW/GLENOSPHERE CONSTRUCT WAS LOOSE. ONE SCREW WAS BROKEN. THE GLENOID BASEPLATE/GLENOSPHERE/SCREWS WERE EXPLANTED. THE CUP/POLY CONSTRUCT WAS EXPLANTED FROM THE HUMERAL SIDE. A 36MM STRYKER CUP/POLY CONSTRUCT WAS REPLACED ON THE HUMERAL STEM."

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 18436671 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "I AM WRITING TO DRAW YOUR ATTENTION TO A DISTRESSING MEDICAL INCIDENT INVOLVING THE FAILED STRYKER REUNION RIGHT SHOULDER REPLACEMENT SURGERY ON (B)(6) 2020. THE PROCEDURE TOOK PLACE AT (B)(6) MEDICAL CENTER, LOCATED AT (B)(6). REGRETTABLY, DESPITE ENDURING NINE MONTHS OF PERSISTENT PAIN AND LIMITED RANGE OF MOTION, I UNDERWENT REVISION SURGERY ON (B)(6) 2021. PREOPERATIVE DIAGNOSIS: RIGHT SHOULDER FAILED REVERSE TOTAL SHOULDER ARTHROPLASTY, AXILLARY NERVE NEUROPRAXIA. POSTOPERATIVE DIAGNOSIS: CAT SCAN EVALUATION OF THE SHOULDER REVEALED AN OS ACROMIALE AND A FRACTURE LINE AROUND THE HUMERAL ENDOPROSTHESIS WITH PROXIMAL LOOSENING. INITIAL STAGES OF SCAPULAR NOTCHING WAS NOTED. THE METAPHYSEAL PORTION OF THE HUMERAL ENDOPROSTHESIS WAS INFERIOR AND SLIGHTLY MEDIAL TO THE INFERIOR ASPECT OF THE GLENOID. THE CENTER OF ROTATION OF THE REVERSE TOTAL SHOULDER ARTHROPLASTY APPEARED NONLATERALIZED."

  Patient problems: Implant Pain; Loss of Range of Motion; Nerve Damage

  MAUDE report 17460599 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT EXPERIENCED EXCESS DRAINAGE FROM INCISION SITE ON (B)(6) 2020 THAT PERSISTED OVER 2 DAYS. PATIENT STARTED TAKING CEPHALEXIN 250 MG 4X/DAY ON (B)(6) 2020. PATIENT REPORTED IMPROVEMENT ON (B)(6) 2020. PATIENT WILL CONTINUE TO TAKE MEDICATION FOR TWO WEEKS AND WILL FOLLOW-UP FOR WOUND CHECK. (B)(6) 2020: INCISION BEGAN BLEEDING AGAIN ON (B)(6) 2020. PATIENT SEEN ON (B)(6) 2020, LABS ORDERED ON (B)(6) 2020. DUE TO EXCESS DRAINAGE, PLAN WILL BE REVISION SURGERY."

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Post Operative Wound Infection

  MAUDE report 10931109 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT, CAME IN LAST WEEK ON 9/17 COMPLAINING OF PAIN AND REDNESS IN THE SHOULDER AS WELL AS A FEVER. AFTER DRAWING A SMALL AMOUNT OF CLOUDY FLUID, [SURGEON] SENT HER IMMEDIATELY TO THE ER AND HAD HER ADMITTED FOR A DEBRIDEMENT AND WASHOUT. SITE COORDINATOR HAS NOT SEEN THE RESULTS OF THE CULTURES YET, BUT SIGNS POINT TO INFECTION PER THE OPERATIVE REPORT AND CLINIC NOTE. [SURGEON] REMOVED AND EXCHANGED ALL HUMERAL COMPONENTS AS WELL AS THE GLENOSPHERE. HE LEFT THE ORIGINAL BASEPLATE. HE EXCHANGED THE OLD REUNION COMPONENTS WITH OTHER REUNION COMPONENTS."

  Patient problems: Erythema; Fever; Implant Pain; Unspecified Infection

  MAUDE report 10701718 ↗
• 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 9993267 ↗
• InjurySep 5, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT'S RIGHT SHOULDER WAS REVISED AFTER PATIENT SUFFERED SEVERAL FALLS AND COMPLAINED OF PAIN. THE GLENOID BASEPLATE WAS FOUND TO HAVE LOOSENED. SURGEON DECIDED TO USE BONE ALLOGRAFT IN THE GLENOID AND A HUMERAL HEAD ON THE EXISTING STEM.

  Patient problems: Fall; Pain

  MAUDE report 7848589 ↗
• 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 CONSEQUENCE

  Patient problems: Discomfort; Rash

  MAUDE report 7575855 ↗
• 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 COBALT/CHROMIUM ALLOY, ONE PART MADE OF TITANIUM/ALUMINUM/VANADIUM ALLOY, AND ONE PART MADE OF PURE TITANIUM.

  Patient problems: Discomfort; Rash

  MAUDE report 7575852 ↗
• 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 7575840 ↗