REUNION 5572-4528Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327098747), received between Sep 5, 2018 and Sep 14, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 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 14, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation; Pain

  MAUDE report 50763391 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  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 22843266 ↗
• 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 18970001 ↗
• 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 01-029R. POSTOPERATIVE HETEROTOPIC OSSIFICATION, ASYMPTOMATIC. INFERIOR SCAPULAR NECK OSTEOPHYTE, ASYMPTOMATIC.

  Patient problems: Extraskeletal ossification

  MAUDE report 18601908 ↗
• 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 18436493 ↗
• 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 15886764 ↗
• 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 15864204 ↗
• InjuryFeb 23, 2021Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  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: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 11368918 ↗
• InjuryFeb 23, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Migration; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Migration

  AS REPORTED: "THE PATIENT RETURNED TO DR. (B)(6) 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 11368872 ↗
• 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 11136208 ↗
• 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 10931125 ↗
• InjuryNov 9, 2020Adverse 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 10813595 ↗
• 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 10701805 ↗
• 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 9993340 ↗
• InjuryOct 20, 2019Loose or Intermittent Connection

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

  Patient problems: No Code Available

  MAUDE report 9212567 ↗
• 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 7848591 ↗