Humeral Cup Stability 103-1006Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03701037309421), received between Apr 15, 2022 and Sep 23, 2026 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Dislocation

  MAUDE report 50873249 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTION AND INSTABILITY ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2026. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 24838598 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED ON (B)(6) 2026, APPROXIMATELY 12 DAYS AFTER THE FIRST REVISION SURGERY WHICH OCCURRED ON (B)(6) 2026. NO FALL OR OTHER TRAUMA REPORTED. BASED ON COMPARING USAGE FORMS ONLY 36MM +6 HUMERAL CUP STABILITY AND +9MM HUMERAL SPACER WAS EXPLANTED DUE TO DISLOCATION OF UNKNOWN CAUSE. THESE PARTS WERE REPLACED WITH 36MM +9HUMERAL CUP STABILITY AND +9MM HUMERAL SPACER. FX V135® HUMELOCK STEM TA6V Ø40/16 L. 120MM CEMENTLESS TI/HA WAS NOT REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 24810650 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 2 YEARS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 36 MM + 6 HUMERAL STABILITY CUP EXPLANTED. THIS WAS REPLACED WITH A 40 MM + 3 HUMERAL STABILITY CUP AND 9 MM SPACER. THE NEWLY IMPLANTED HUMERAL CUP IS OF A LARGER DIAMETER THAN THE 36 MM GLENOSPHERE, WHICH IS A DEVIATION FROM SYSTEM SURGICAL TECHNIQUE, WHICH STATES THAT "THE CUP SIZE IS LINKED TO THE GLENOSPHERE SIZE" (STEP 17).

  Patient problems: Joint Dislocation

  MAUDE report 21266512 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 4 WEEKS AFTER THE PRIOR REVISION SURGERY WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. THE PRIMARY SURGERY WAS A PLACEMENT OF A COMPETITOR SYSTEM AT AN UNKNOWN DATE, UTILIZING A SYSTEM TO COMPENSATE FOR EXTENSIVE BONE LOSS. THE FIRST REVISION SURGERY WAS A PLACEMENT OF AN FX REVERSE SYSTEM STEM WHILE RETAINING COMPETITOR GLENOID ASSEMBLY, WHICH IS A PATIENT-SPECIFIC CUSTOM-MADE PART. 36 MM + 6 HUMERAL STABILITY CUP EXPLANTED AND REPLACED WITH A 36 MM + 9 HUMERAL STABILITY CUP AND 9 MM SPACER.

  Patient problems: Joint Dislocation

  MAUDE report 20431475 ↗
• InjuryApr 15, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO PAIN. APPROXIMATELY 1 YEARS AFTER THE LAST SURGERY. THE SURGEON EXPLANTED 1 GLENOID BASEPLATE (24), 1 CENTERED GLENOSPHERE (36), 2 STANDARD SCREW (20), 2 STANDARD SCREW (25) AND 1 HUMERAL CUP (36/6). THE SURGEON IMPLANTED 1 POST EXTENSION (6), 1 GLENOID BASEPLATE (24), 1 ECCENTRIC GLENOSPHERE (36), 1 HUMERAL CUP (36/3), 1 HUMERAL SPACER (9), 2 STANDARD SCREW (30) AND 2 STANDARD SCREW (25).

  Patient problems: Pain

  MAUDE report 14116820 ↗