REUNION 5573-C-3606Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327098891), received between Jan 15, 2019 and Jan 30, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 18606726 ↗
• 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: SUBJECT (B)(4). POSTOPERATIVE HETEROTOPIC OSSIFICATION, SYMPTOMATIC. HO OF SUPERIOR/POSTERIOR ASPECTS OF SHOULDER AND INFERIOR GLENOID NECK. SUBJECT COMPLAINS OF OCCASIONAL PAIN."

  Patient problems: Extraskeletal ossification; Implant Pain

  MAUDE report 18602125 ↗
• 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: SUBJECT (B)(6). POSTOPERATIVE HETEROTOPIC OSSIFICATION, ASYMPTOMATIC. INFERIOR SCAPULAR NECK OSTEOPHYTE, ASYMPTOMATIC."

  Patient problems: Extraskeletal ossification

  MAUDE report 18601584 ↗
• InjuryNov 8, 2023Osseointegration Problem; Appropriate Device Problem Term/Code Not Available; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available

  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: Inadequate Osseointegration; Osteolysis

  MAUDE report 18096787 ↗
• MalfunctionApr 7, 2021Fracture; Fracture

  AS REPORTED: "PRIMARY PROCEDURE, LEFT REVERSE SHOULDER. IT WAS REPORTED THAT WHILE INSERTING AND POSITIONING THE GLENOSPHERE, THE THREADED PORTION OF THE INSERTER BROKE OFF IN THE GLENOSPHERE. A SURGICAL DELAY OF 30 MINUTES WAS CAUSED BY TRYING TO REMOVE THE BROKEN THREADED PORTION, WHICH WAS UNSUCCESSFUL. AS THE BROKEN THREADED PORTION WAS NOT SITTING PROUD, SURGEON ELECTED TO LEAVE THE IMPLANT IN. SURGERY WAS COMPLETED SUCCESSFULLY."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11626451 ↗
• 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 10931120 ↗
• 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 9862305 ↗
• 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 METALLOSIS AROUND THE IMPLANTS AND OSTEOLYSIS AROUND THE HUMERAL CUP. REVISION SURGERY OCCURRED.

  Patient problems: Osteolysis; Toxicity

  MAUDE report 8680335 ↗
• InjuryFeb 21, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S REVERSE SHOULDER WAS REVISED DUE TO DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8359156 ↗
• 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 8249967 ↗