REUNION 5572-4532Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327098754), received between Jun 6, 2018 and Sep 8, 2026 — classified as 16 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a revision of a left ReUnion reverse shoulder arthroplasty, the tip of the center screw and one peripheral screw from the primary procedure were found to be broken. The existing components were revised and replaced with a new Stryker ReUnion baseplate, screws, cup, liner, and glenosphere.

  Patient problems: Insufficient Information

  MAUDE report 50672936 ↗
• InjuryMar 19, 2024Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PERIPHERAL SCREW PULLED THROUGH THE BASEPLATE LOCKING MECHANISM. BASEPLATE WAS PULLED OUT OF PATIENT WHILE ONE OF THE PERIPHERAL SCREWS REMAINED INTACT IN THE PATIENTS GLENOID." UPDATE 04 FEB 2024: INITIAL SURGERY TOOK PLACE ON (B)(6) 2021. SURGEON WAS CONCERNED ABOUT CALCAR BONE LOSS, SO MODIFIED AN IMPLANT AND CEMENTED A LONG STEM. STANDARD BASEPLATE AND TUBEROSITY REPAIR. REVISION SURGERY DETAILS: THE GLENOID WAS LOOSE. GLENOSPHERE APPEARED STILL ON THE BASEPLATE, BUT THE SCREW WENT THROUGH IN THE SOFT TISSUES. PATIENT WAS REVISED TO A HEMIARTHROPLASTY. VERY MEDICALLY UNWELL (POOR MEDICAL STATUS AND WEIRD PRESENTATION (BONE LOSS - OSTEOPOROSIS)). PATIENT COULD HAVE A NEUROPATHIC SHOULDER FROM HIS CERVICAL SPINE WHICH COULD EXPLAIN LOOSENING. DEVICES SUCCESSFULLY REMOVED.

  Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis

  MAUDE report 18936402 ↗
• 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 17460594 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REUNION RSA STUDY: (B)(4). PATIENT FELT A POP 7 WEEKS POST-OP AND CAME IN. IMAGES SHOWED STRESS FRACTURE AT BASE OF ACROMION W/O SUBSTANTIAL DISPLACEMENT. SHE DOES HAVE OSTEOPOROSIS WHICH MAY HAVE CONTRIBUTED. ACTIONS TAKEN: SLING WITH LIMITED MOBILITY. RESOLVED WITH SEQUELAE: (B)(6) 2021.

  Patient problems: Bone Fracture(s); Loss of Range of Motion; Osteopenia/ Osteoporosis

  MAUDE report 17254624 ↗
• InjuryFeb 11, 2022Break; Fracture; Break; Fracture

  "IT WAS REPORTED THAT THE PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO A BROKEN PERIPHERAL AND CENTER SCREW IN THE BASEPLATE. ALL DEVICES EXCEPT FOR THE STEM WERE REVISED. THE CUP WAS REVISED IN ORDER TO ACCESS THE GLENOSPHERE AND BECAUSE THE SURGEON WANTED TO IMPLANT THICKER IMPLANTS."

  Patient problems: Failure of Implant

  MAUDE report 13518625 ↗
• 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 (B)(6) 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 10701821 ↗
• 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 9993269 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT RECEIVED A PRIMARY RSA ON (B)(6) 2016, WITH NO ISSUES. PATIENT CAME BACK AND HAD A SHOULDER SCOPE ON (B)(6) 2019, WHICH PRESENTED WHAT APPEARED TO BE VISIBLE METALLOSIS. PATIENT THEN CAME BACK ON (B)(6) 2019 TO HAVE HIS RSA REMOVED AND HAVE A SHOULDER SPACER IMPLANTED." ADDITIONALLY REPORTED: "TISSUE WAS SENT TO THE LAB AND METALLOSIS, AS WELL AS P ACNES WERE CONFIRMED. PATIENT CURRENTLY AN ANTIBIOTIC SPACER IMPLANTED WITH GENT/VANC CEMENT AROUND THE HEAD/NECK JUNCTION."

  Patient problems: Injury; Reaction

  MAUDE report 9862686 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT RECEIVED A PRIMARY RSA ON (B)(6)2016 , WITH NO ISSUES. PATIENT CAME BACK AND HAD A SHOULDER SCOPE ON (B)(6)2019 , WHICH PRESENTED WHAT APPEARED TO BE VISIBLE METALLOSIS. PATIENT THEN CAME BACK ON (B)(6)2019 TO HAVE HIS RSA REMOVED AND HAVE A SHOULDER SPACER IMPLANTED." ADDITIONALLY REPORTED: "TISSUE WAS SENT TO THE LAB AND METALLOSIS, AS WELL AS P ACNES WERE CONFIRMED. PATIENT CURRENTLY AN ANTIBIOTIC SPACER IMPLANTED WITH GENT/VANC CEMENT AROUND THE HEAD/NECK JUNCTION."

  Patient problems: Injury; Reaction

  MAUDE report 9862620 ↗
• InjuryOct 20, 2019Loose or Intermittent Connection

  SUSPECTED GLENOID LOOSENING OF REUNION RSA IMPLANTS LEADING TO REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 9212570 ↗
• InjuryJun 11, 2019Device Dislodged or Dislocated

  AS REPORTED: "PATIENT HAD IN REUNION REVERSE IMPLANTS. PATIENT FELL AND DISLOCATED. THE ATTENDING SURGEON THOUGHT GLENOSPHERE WAS NOT ALL THE WAY SEATED". REP CONFIRMED REVISION WAS PERFORMED BY INDICATING THAT THE HOSPITAL DISPOSED OF THE IMPLANTS.

  Patient problems: Fall

  MAUDE report 8689105 ↗
• InjurySep 5, 2018Loosening of Implant Not Related to Bone-Ingrowth

  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 7848588 ↗
• InjurySep 5, 2018Device Slipped

  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 7848587 ↗
• 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 JANUARY 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 7575859 ↗
• 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 7575850 ↗
• 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 7575781 ↗