REUNION 5567-P-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327424973), received between Apr 23, 2020 and Jan 29, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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). INTRAOPERATIVE FRACTURE OF HUMERUS. NONDISPLACED GREATER TUBEROSITY FRACTURE."

  Patient problems: Bone Fracture(s)

  MAUDE report 18600066 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "INTRAOPERATIVE FRACTURE OF THE HUMERUS. EVENT WAS RESOLVED WITHOUT SEQUELAE (WITHOUT ADDITIONAL MEDICAL INTERVENTION)."

  Patient problems: Limb Fracture; Osteopenia/ Osteoporosis

  MAUDE report 18387030 ↗
• MalfunctionFeb 17, 2023Component Missing; Inaccurate Information; Component Missing; Inaccurate Information

  T&E TEAM RECEIVED A FEMORAL STEM WHICH WAS PACKAGED IN A BOX FOR A PRESS-FIT HUMERAL STEM. THIS EVENT DID NOT AFFECT THE OUTCOME OF THE CASE. THE STEM BOX WAS LABELED A SHOULDER REUNION S STEM BUT THEN INSIDE THE BOX WAS A HIP STEM. WE REALIZED THIS IMMEDIATELY AND OPENED THE CORRECT SIZE STEM AS WE HAD BACKUP IMPLANTS FOR THAT CASE. AS REPORTED BY REP, WHO WAS ASKED IF THE OUTER BOX WAS SHRINK WRAPPED, AND IF THE STEM WAS IN AN OUTER AND INNER STERILE BLISTER: "YES IT WAS SHRINK WRAPPED. STEM WAS ALSO IN ITS STERILE PACKAGING CORRECTLY. EVERYTHING ABOUT THE MAKE UP OF THE BOX AND PACKAGING WAS NORMAL EXCEPT FOR THE STEM INSIDE BEING A HIP STEM INSTEAD OF A REUNION S SHOULDER STEM AS LABELED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400462 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE CUSTOMER EXPERIENCED AN INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12975717 ↗
• 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 10701713 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT IS EXPERIENCING PAIN AND NUMBNESS IN THE RIGHT LATERAL ARM, FOREARM, AND HAND AND IS UNABLE TO FLEX RIGHT ELBOW. PATIENT REPORTS THAT THE SYMPTOMS OCCURRED AFTER THE PAIN CATHETER WAS REMOVED. NERVE CONDUCTION STUDY PERFORMED ON (B)(6) 2020 INDICATES "ACUTE RIGHT BRACHIAL PLEXOPATHY AFFECTING ALL PARTS OF THE BRACHIAL PLEXUS, BUT MOST SIGNIFICANTLY, THE UPPER TRUNK."

  Patient problems: Implant Pain; Loss of Range of Motion; Numbness

  MAUDE report 10672225 ↗
• 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 9993058 ↗