Identity™ SAHHA001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024626997), received between Sep 11, 2023 and Sep 4, 2024 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT DEVELOPED A DVT/PE APPROXIMATELY 2 MONTHS POST IMPLANTATION OF A LEFT SHOULDER ARTHROPLASTY. THE PATIENT WAS HOSPITALIZED AND PLACED ON MEDICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 20138260 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT ANATOMICAL TOTAL SHOULDER ARTHROPLASTY. ONE MONTH POST-OP, THE PATIENT DEVELOPED SUBCUTANEOUS SWELLING REDNESS AT THE PROXIMAL INCISION, AND A HEMATOMA. THE PATIENT WAS PLACED ON CLINDAMYCIN AND DOXYCYCLINE AND WAS RESOLVED WITHOUT FURTHER COMPLICATIONS. ALL IMPLANTS REMAIN IN PLACE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Erythema; Hematoma; Swelling/ Edema

  MAUDE report 20137101 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT DEVELOPED DRAINAGE FROM A SURGICAL SITE WOUND APPROXIMATELY 10 DAYS POST IMPLANTATION OF A LEFT SHOULDER ARTHROPLASTY. 15 DAYS POST IMPLANTATION, THE DRAINAGE SITE/HEMATOMA WAS OPENED UP AND A MAJORITY WAS EXPRESSED OUT. A DRESSING WAS APPLIED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fluid Discharge; Hematoma

  MAUDE report 20136750 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Impaired Healing

  MAUDE report 19987476 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Fluid Discharge; Hematoma

  MAUDE report 17719100 ↗