REUNION 5572-2800Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07613327098709), received between Mar 26, 2018 and Aug 19, 2025 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2025Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Pain

  MAUDE report 22843525 ↗
• 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 18970011 ↗
• InjuryMar 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 PROVIDED ON A DIFFERENT DATE. INITIAL SURGERY TOOK PLACE ON A LATER DATE 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 18936397 ↗
• InjuryNov 8, 2023Material Deformation; Osseointegration Problem; Material Deformation; Osseointegration Problem

  THE SURGEON SCHEDULED A REVISION SURGERY WITH A STRYKER REPRESENTATIVE. DURING THE SURGERY, IT WAS FOUND THAT THE BASEPLATE/SCREW/GLENOSPHERE CONSTRUCT WAS LOOSE, WITH TWO OF THE FOUR SCREWS NOT CONTAINED WITHIN THE CONSTRUCT. THE GLENOID BASEPLATE/GLENOSPHERE/SCREWS AND THE CUP/POLY CONSTRUCT WERE REMOVED. A 40MM HUMERAL HEAD WAS ATTACHED TO THE EXISTING HUMERAL STEM. THE INDICATION FOR THE PRIMARY PROCEDURE WAS A FRACTURE. THE REVISION SURGERY WAS SUCCESSFUL.

  Patient problems: Failure of Implant; Foreign Body In Patient; Inadequate Osseointegration; Osteolysis

  MAUDE report 18096712 ↗
• 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 17460596 ↗
• InjuryJun 19, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF RUBBING AND GRINDING IN THEIR ARM AND THE DOCTOR SAID IT WOULD GET BETTER. THE PATIENT SAYS THAT THEIR CONDITION HAS GOTTEN WORSE. THE PATIENT CANNOT USE THEIR ARM AND/OR RAISE IT ABOVE THEIR HEAD. PATIENT WANTS THEIR ARM FIXED AND IS SEEKING COMPENSATION. "EQUIPMENT" HAS COME APART IN PATIENT'S ARM. PATIENT MIGHT NEED A REVISION. CT SCAN IS SCHEDULED TO DETERMINE IF THERE IS ENOUGH BONE FOR A REVISION. PATIENT CANNOT WORK AND IS ON DISABILITY.

  Patient problems: Discomfort; Joint Dislocation; Loss of Range of Motion

  MAUDE report 17159179 ↗
• InjuryJun 9, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT REUNION BASEPLATE/GLENOSPHERE/ SCREWS BECAME LOOSE AFTER REVISION SURGERY. SCREWS LOOK TO HAVE WORKED THEMSELVES THROUGH BASEPLATE ON GLENOID SIDE FULL REMOVAL OF GLENOID PARTS AND HEMI HEAD IMPLANTED. THE PATIENT UNDERWENT A REVISION SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17101784 ↗
• InjuryMar 22, 2023Failure to Osseointegrate; Failure to Osseointegrate

  A REVISION SURGERY WAS PLANNED DUE TO GLENOID FAILURE. IT IS SUSPECTED THAT THE REUNION BASEPLATE NEVER ACHIEVED BI CORTICAL FIXATION FROM THE CENTER SCREW.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16591964 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HAD THEIR SHOULDER STEM REMOVED 6 WEEKS POST OPP DUE TO METALLOSIS.

  Patient problems: Metal Related Pathology

  MAUDE report 15886646 ↗
• InjuryMar 21, 2022Material Deformation; Material Deformation

  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: Insufficient Information

  MAUDE report 13839351 ↗
• InjuryFeb 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "THE SURGEON REVISED PATIENT FROM REVERSE TO HEMI SHOULDER DUE TO REOCCURRING DISLOCATIONS." NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13582002 ↗
• InjuryMay 20, 2021Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PATIENT EXPERIENCED A FALL. UPON X-RAY EXAMINATION, THE SURGEON NOTICED THE BASEPLATE WAS LOOSENED REQUIRING A REVISION SURGERY."

  Patient problems: Failure of Implant

  MAUDE report 11855633 ↗
• InjuryFeb 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "THE PATIENT RETURNED TO DR.'S OFFICE FOR A FOLLOW-UP. UPON EXAMINING X-RAYS IT WAS OBVIOUS THAT PERIPHERAL SCREWS HAD MIGRATED THROUGH THE BASEPLATE REQUIRING REVISION SURGERY."

  Patient problems: Failure of Implant

  MAUDE report 11368827 ↗
• MalfunctionJan 11, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "IMPLANTED BASEPLATE AND WHEN PUTTING IN PERIPHERAL SCREWS THE SCREW WENT THROUGH THE BASEPLATE. THE METAL CASTING THAT HOLDS THE SCREW WAS DEFORMED. WE HAD TO TAKE IT OUT AND PUT IN A NEW ONE. PATIENT AND OUTCOME WERE FINE." THE BASEPLATE AND 6 SCREWS WERE WASTED. THERE ARE NO ALLEGATIONS AGAINST THE WASTED SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1 HOUR." ADDITIONAL INFORMATION RECEIVED FROM REP 12/24/2020: 5 SCREWS THAT WERE WASTED (1 CENTER SCREW AND 4 PERIPHERALS) ALONG WITH THE BASEPLATE THAT WE HAD TO SWITCH OUT. WHEN WE TOOK OUT THE BASEPLATE AND SCREWS THAT HAD ALREADY BEEN USED, THE SURGEON WANTED BRAND NEW SCREWS FOR EVERYTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11152679 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "INTRA-OP CULTURES CAME BACK POSITIVE FOR P. ACNES. NO GROSS PURULENCE NOTED DURING SURGERY. PATIENT STARTED TAKING AMOXICILLIN ON (B)(6) 2020. CONTINUED FOLLOW-UP SCHEDULED WITH INFECTIOUS DISEASE CLINIC TO MONITOR."

  Patient problems: Bacterial Infection

  MAUDE report 11136149 ↗
• InjuryNov 18, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT REVERSE SHOULDER WAS REVISED AFTER PATIENT COMPLAINT OF PAIN AND X-RAYS SHOWING A PERIPHERAL SCREW LOOSE IN THE JOINT. INTRA-OPERATIVELY, IT WAS NOTED THAT THE PERIPHERAL SCREWS HAD 'WINDSHIELD WIPERED' IN THE JOINT, ETCHING THE GLENOSPHERE AND PASSING THROUGH THE BASEPLATE INTO THE JOINT. THE BASEPLATE, GLENOSPHERE AND CENTER SCREW CAME OUT ALL IN ONE PIECE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 10864670 ↗
• 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 9993204 ↗
• InjuryFeb 18, 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 9722935 ↗
• InjuryJan 17, 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 9601864 ↗
• InjuryOct 20, 2019Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Injury; No Code Available

  MAUDE report 9212565 ↗
• 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 8688894 ↗
• InjuryJun 7, 2019Device Dislodged or Dislocated

  THE PERIPHERAL SCREWS COMPLETELY DISASSOCIATED FROM THE GLENOID BASEPLATE, EVEN WITH THE GLENOSPHERE INTACT. THERE WAS SIGNIFICANT BONE LOSS ON THE GLENOID, AND THE MICROMOTION FROM THE BASEPLATE & SCREWS "ROCKING" LEFT UNCONTAINED DEFECTS IN THE GLENOID. THERE WAS METALOSIS AROUND THE IMPLANTS AND OSTEOLYSIS AROUND THE HUMERAL CUP. REVISION SURGERY OCCURRED.

  Patient problems: Osteolysis; Toxicity

  MAUDE report 8680337 ↗
• InjuryMar 20, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A STAGE 1 REVISION OF THE PATIENT'S LEFT SHOULDER WAS PERFORMED DUE TO INFECTION. SURGEON REPORTED INFECTION AS (B)(6). 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 8438477 ↗
• 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 8359165 ↗
• InjuryJan 15, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT REVERSE SHOULDER WAS REVISED DUE TO DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. SURGEON REPORTED A POSSIBLE CAUSE/ CONTRIBUTOR OF POSSIBLE SOFT TISSUE IN THE MORRIS TAPER. PATIENT WAS REVISED TO A CONSTRUCT OF THE SAME CATALOG NUMBERS. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: No Code Available

  MAUDE report 8250937 ↗