REUNION 5572-4540Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327098778), received between Oct 1, 2018 and Aug 4, 2023 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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). 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 17460802 ↗
• InjuryNov 29, 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 15883197 ↗
• 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 15864038 ↗
• 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 11368881 ↗
• MalfunctionJan 11, 2021Material Invagination; Failure to Align; Material Invagination; Failure to Align

  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."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11152678 ↗
• MalfunctionJan 11, 2021Material Invagination; Failure to Align; Material Invagination; Failure to Align

  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."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11152677 ↗
• 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 10813655 ↗
• InjuryMar 21, 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 MRSA. 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: Unspecified Infection

  MAUDE report 8441676 ↗
• InjuryMar 21, 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 MRSA. 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: Unspecified Infection

  MAUDE report 8441624 ↗
• InjuryOct 1, 2018Device Dislodged or Dislocated

  WE WERE REVISING A REVERSE TOTAL SHOULDER. THE BASEPLATE WITH THE GLENOSPHERE CAME OUT ALL TOGETHER. THERE WAS NO INGROWTH ON THE BASEPLATE. THE PATIENT HAD NO INFECTION. THE SURGEON HAD TO COVERT HIM TO A HEMI ARTHROPLASTY AS THERE WAS NO BONE LEFT AROUND THE GLENOID.

  Patient problems: No Code Available

  MAUDE report 7923896 ↗