Identity™ SAHS1111Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024627086), received between Sep 4, 2024 and Sep 4, 2024 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Erythema1
- Hematoma1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 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 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 20136931 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.