Humeral Cup Stability 103-1003Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03701037309414), received between Jan 4, 2022 and Sep 14, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50762728 ↗
• InjurySep 14, 2026Improper or Incorrect Procedure or Method

  Revision occurred on (b)(6) 2026 approximately after 14 days after the primary surgery which happened on (b)(6) 2026. No fall or trauma was reported. Based on comparing usage forms HUMERAL CUP STABILITY PE/TA6V Ø36/+3 and FX V135 HUMERAL SPACER TA6V +9mm was explanted due to cup and spacer disassociated from stem. This part was replaced with HUMERAL CUP STANDARD PE/TA6V Ø36/+3 and HUMERAL SPACER TA6V +9mm. FX V135® HUMELOCK STEM TA6V Ø36/10 L. 120MM CEMENTLESS Ti/HAwas not replaced.

  Patient problems: Joint Laxity

  MAUDE report 50756685 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 7 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 36 MM + 3 HUMERAL STABILITY CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH A 36 MM + 9 135/145* HUMERAL STABILITY CUP.

  Patient problems: Joint Dislocation

  MAUDE report 23791410 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 15 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 36 MM + 3 HUMERAL STABILITY CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH AN IDENTICAL PART.

  Patient problems: Joint Dislocation

  MAUDE report 23577363 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, A POST EXTENSION AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 20851621 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 5 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(4) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO A DISLOCATION OF UNKNOWN CAUSE. 36 MM + 3 HUMERAL STABILITY CUP EXPLANTED AND REPLACED WITH A 36 MM + 9 HUMERAL STABILITY CUP.

  Patient problems: Joint Dislocation

  MAUDE report 20432941 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 14 DAYS AFTER THE PREVIOUS REVISION SURGERY WHICH OCCURRED ON (B)(6) 2024. PRIMARY SURGERY OCCURRED ON (B)(6) 2024. THE FIRST REVISION SURGERY WAS FOR A PATIENT FALL. FOR THIS REVISION, NO FALL OR OTHER TRAUMA REPORTED. THIS REVISION OCCURRED FOR DISLOCATION OF NO KNOWN CAUSE. 36 MM + 3 HUMERAL STABILITY CUP AND 9 MM HUMERAL SPACER EXPLANTED. THESE PARTS WERE REPLACED WITH A 50X19 CENTERED HEAD AND 24 MM ECCENTRIC ADAPTER. DISTRIBUTOR CONFIRMS THAT THIS IS A CONVERSION TO A HEMI RESULTING IN NO HUMERAL CUP PRESENT IN THE SYSTEM. DISTRIBUTOR CONFIRMS THAT NO NON-FX PRODUCT WAS IMPLANTED FOR EXPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 19096375 ↗
• InjuryJul 19, 2023Unstable; Unstable

  THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP WAS EXPLANTED. A CUP AND A REVERSED ADAPTER WERE IMPLANTED.

  Patient problems: Subluxation

  MAUDE report 17348872 ↗
• InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR FALL. APPROXIMATELY 49 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP (36/3). THE SURGEON IMPLANTED 1 HUMERAL CUP (36/3).

  Patient problems: Insufficient Information

  MAUDE report 13899237 ↗
• InjuryJan 4, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 11 MONTHS AFTER THE PRIMARY SURGERY ON (B)(6) 2021. THE REVISION WAS DUE TO DISLOCATION . THE SURGEON EXPLANTED THE STANDARD HUMERAL CUP (36/+3) AND IMPLANTED A STABILITY HUMERAL CUP (36/+6).

  Patient problems: Insufficient Information

  MAUDE report 13158557 ↗