REUNION 5570-3604Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327098365), received between Jun 6, 2018 and Sep 10, 2026 — classified as 15 injuries, 1 malfunction.

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 10, 2026Insufficient Device Problem Information

  A Stryker Reunion Reverse shoulder implant was revised using new Stryker Reunion implants.

  Patient problems: Insufficient Information

  MAUDE report 50716217 ↗
• InjuryAug 19, 2025Osseointegration Problem; Appropriate Device Problem Term/Code Not Available; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available

  REVISION OF LEFT SHOULDER. TRAY, LINER, BASEPLATE, GLENOSPHERE AND SCREWS WERE REMOVED, AND ANATOMIC HEAD WAS PLACED ON EXISTING STEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 22843526 ↗
• InjuryApr 9, 2024Unstable; Unstable

  THE PATIENT UNDERWENT A REVISION SURGERY. IN AN UPDATE, IT WAS MENTIONED THAT THE PATIENT WAS UNSTABLE, LEADING THE SURGEON TO CHANGE THE IMPLANTS TO ADDRESS THE INSTABILITY ISSUES. REUNION IMPLANTS WERE USED TO UPSIZE THE IMPLANTS AND WASH OUT THE PATIENT DURING THE SURGERY.

  Patient problems: Joint Laxity

  MAUDE report 19073995 ↗
• 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 18606772 ↗
• InjuryJan 29, 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: (B)(6). POSTOPERATIVE HETEROTOPIC OSSIFICATION, ASYMPTOMATIC. INFERIOR SCAPULAR NECK OSTEOPHYTE, ASYMPTOMATIC".

  Patient problems: Extraskeletal ossification

  MAUDE report 18601591 ↗
• InjuryAug 4, 2023Break; Fracture; Migration; Break; Fracture; Migration

  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: Failure of Implant; Implant Pain; Loss of Range of Motion; Nerve Damage

  MAUDE report 17461207 ↗
• InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ACROMIAL STRESS FRACTURE NON-UNION. PATIENT EXPERIENCING PAIN OVER PROXIMAL AND DISTAL LOCKING BOLT SITES. REOPERATION TO REMOVE LOCKING BOLTS".

  Patient problems: Bone Fracture(s); Implant Pain

  MAUDE report 15864072 ↗
• MalfunctionNov 23, 2021Inaccurate Information; Inaccurate Information

  AS REPORTED; "THE NON-STERILE SHOULDER INSERT INSIDE THE PACKAGING WAS NOT THE SAME IMPLANT AS WHAT WAS LABELED. THE IMPLANT BOX WAS A 36+4 CUP, AND INSIDE WAS WHAT APPEARED TO BE A 36+4 INSERT. THERE WAS NO BACKUP 36+4 CUP, SO WE COULD NOT PROCEED WITH PUTTING THIS IN AS THE FINAL IMPLANT. WE HAD TO SWITCH TO A SIZE 32 FOR THE CUP AND INSERT, BUT ENDED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF ABOUT AN HOUR DUE TO TAKING OUT THE IMPLANTS TO SWITCH TO SIZE 32. DURING A LEFT SHOULDER CASE, THE REP FOUND THAT THE BOX FOR A 36X4 HUMERAL CUP (CATALOG 5570-3604 LOT RHHJRA) HAD ALREADY BEEN OPENED. INSIDE THE BOX WAS SOME PACKAGING FOR COMPETITOR GAUZE, AND A ¿DIRTY¿ SHOULDER INSERT. THE REP EXPLAINED THAT THERE DIDN¿T APPEAR TO BE ANY BIOBURDEN ON THE INSERT, THAT IT LOOKED LIKE IT MIGHT HAVE BEEN DROPPED ON THE FLOOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860043 ↗
• 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 10931126 ↗
• 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 9993265 ↗
• 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 9862281 ↗
• InjuryFeb 19, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT SHOULDER WAS REVISED DUE TO IMPLANT LOOSENING. DUE TO THE PRESENCE OF A HEMATOMA, THE SURGEON REPORTED THAT TRAUMA HAD TO BE A FACTOR. THE PATIENT'S ENTIRE SHOULDER CONSTRUCT EXCEPT FOR THE HUMERAL STEM WAS REVISED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Injury

  MAUDE report 9727818 ↗
• InjuryMar 29, 2019Device Dislodged or Dislocated

  SURGEON REPORTED THAT LEFT REVERSE SHOULDER REPLACEMENT DUE TO A FRACTURE HAS SUBLUXED AND DISLOCATED. CT SCAN SHOWED LARGE AMOUNT OF FLUID IN THE JOINT. SURGEON DECIDED TO REVISE THE SHOULDER, EVACUATE AND THE FLUID. HE INCREASED THE TENSION WITH INCREASED GLENIOSPHERE OFFSET AND THICKER CUP AND LINER. THE SHOULDER APPEARED STABLE AND THE SURGERY WAS PERFORMED WITHOUT INCIDENT.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 8466013 ↗
• 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 7575916 ↗
• 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 7575851 ↗
• 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 7575843 ↗