Identity™ SAHS1108Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Identity (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024627055), received between Jul 5, 2024 and Sep 4, 2024 — classified as 2 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Bone Fracture(s)1
- Fluid Discharge1
- Hematoma1
- Pulmonary Embolism1
- Thrombosis/Thrombus1
Recent adverse event reports
The 3 most recent of 3 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 ARTHOPLASTY. 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 20138259 ↗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 20136714 ↗MalfunctionJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UPON REASSESSMENT IT WAS DISCOVERED THAT THE REPORTED EVENT OF BONE FRACTURE IS NOT CONSIDERED A SERIOUS INJURY AS A MILD INJURY, ILLNESS, OR IMPAIRMENT OCCURRED WHICH DOES NOT REQUIRE PRESCRIBED MEDICAL TREATMENT.
Patient problems: Bone Fracture(s)
MAUDE report 19679823 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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