TiN Coated Glenosphere 115-3610Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03701037300800), received between Feb 21, 2022 and Jan 23, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Lack of Effect” (1 report).

1 other recall cover devices cleared under the same FDA submission (K191146); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

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

  REVISION OCCURRED APPROXIMATELY 8 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT IMPLANT SITE. A 36 MM CENTERED GLENOSPHERE, 36 MM + 6 STANDARD HUMERAL CUP, 2 STANDARD SCREWS, AND 2 LOCKING SCREWS WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE, 36 MM + 9 STABILITY HUMERAL CUP, AND 4 LOCKING SCREWS.

  Patient problems: Medical device site infection

  MAUDE report 24167400 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 8 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 CENTERED GLENOSPHERE AND A 36 MM + 6 STABILITY HUMERAL CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 40 MM CENTERED GLENOSPHERE AND A 40 MM + 9 STABILITY HUMERAL CUP.

  Patient problems: Joint Dislocation

  MAUDE report 23314008 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 1 YEAR AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INSTABILITY OF UNKNOWN CAUSE. A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 3 HUMERAL STANDARD CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 40 MM CENTERED GLENOSPHERE AND A 40 MM + 6 HUMERAL STABILITY CUP.

  Patient problems: Joint Laxity

  MAUDE report 23100226 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 6 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT THE IMPLANT SITE. A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 9 135/145 STABILITY HUMERAL CUP WERE EXPLANTED. THERE ITEMS WERE REPLACED BY A 36 MM CENTERED GLENOSPHERE, A 36 MM + 3 135/145 STABILITY HUMERAL CUP, AND A 9 MM SPACER.

  Patient problems: Medical device site infection

  MAUDE report 22963797 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 4 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT IMPLANT SITE. A 36 MM CENTERED GLENOSPHERE, A 36 MM + 3 STANDARD HUMERAL CUP, 2 LOCKING SCREWS, AND 2 STANDARD SCREWS. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE, 36 MM + 3 STANDARD HUMERAL CUP, 2 STANDARD SCREWS, AND 2 LOCKING SCREWS.

  Patient problems: Medical device site infection

  MAUDE report 22196340 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 1 YEAR AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT IMPLANT SITE. A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 6 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 6 HUMERAL STABILITY CUP.

  Patient problems: Medical device site infection

  MAUDE report 22196339 ↗
• InjuryMar 7, 2025Adverse 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)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH 40 MM CENTERED GLENOSPHERE AND A 40 MM + 6 135/145 HUMERAL STABILITY CUP.

  Patient problems: Joint Dislocation

  MAUDE report 21551898 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 4 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INSTABILITY. 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE WITH SCREW AND A 36 MM + 9 STABILITY HUMERAL CUP.

  Patient problems: Joint Laxity

  MAUDE report 20315728 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY OCCURRED APPROXIMATELY 7 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED FOR RECURRENT DISLOCATIONS OF UNKNOWN CAUSE. 36 MM CENTERED GLENOSPHERE, 36 MM + 3 STANDARD HUMERAL CUP, AND 2 LOCKING SCREWS EXPLANTED. THESE PARTS WERE REPLACED WITH A 40 MM CENTERED GLENOSPHERE, 40 MM + 6 STABILITY HUMERAL CUP, 9 MM SPACER, AND 2 LOCKING SCREWS.

  Patient problems: Joint Dislocation

  MAUDE report 19058861 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WILL BE REVISED DUE TO AN INSTABILITY ON (B)(6) 2024.

  Patient problems: Joint Laxity

  MAUDE report 18826174 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED APPROXIMATELY 7 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. PATIENT DISLOCATED FOR UNKNOWN REASONS AND WAS NOT ABLE TO MOVE THEIR ARM. 36 MM CENTERED GLENOSPHERE AND 36 MM + 9 HUMERAL STABILITY CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 40 MM CENTERED GLENOSPHERE, A 40 MM + 6 STABILITY HUMERAL CUP, AND A 9 MM SPACER.

  Patient problems: Joint Dislocation

  MAUDE report 18435651 ↗
• InjuryNov 3, 2023Lack of Effect; Lack of Effect

  REVISION OCCURRED APPROX. 8 MONTHS AFTER PRIMARY SURGERY DUE TO PATIENT PAIN; PRIMARY SURGERY OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA NOTED. 36 MM CENTERED GLENOSPHERE AND 36 MM + 6 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 32 MM CENTERED GLENOSPHERE, 9 MM SPACER, 32 MM + 3 HUMERAL CUP, AND A LOCKING SCREW.

  Patient problems: Implant Pain

  MAUDE report 18066446 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DISLOCATED APPROXIMATELY 3 MONTHS AFTER PRIMARY SURGERY. NO FALL OR TRAUMA REPORTED. 36 MM +6 HUMERAL CUP AND 36 MM GLENOSPHERE EXPLANTED. REPLACED WITH A 40 MM + 6 STABILITY HUMERAL CUP AND 40 MM GLENOSPHERE WITH A 9MM SPACER.

  Patient problems: Joint Dislocation

  MAUDE report 17975499 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISLOCATION OCCURRED APPROXIMATELY 3 MONTHS AFTER INITIAL IMPLANTATION. NO PAIN OR TRAUMA REPORTED. GLENOID BASEPLATE, 36 MM GLENOSPHERE, 36 MM + 6 STANDARD HUMERAL CUP, CEMENTLESS POST EXTENSION, AND FOUR SCREWS EXPLANTED. REPLACED WITH OFFSET HEAD AND 24 MM TAPER ADAPTER.

  Patient problems: Joint Dislocation

  MAUDE report 17966219 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISLOCATION OCCURRED APPROXIMATELY 2 MONTHS AFTER INITIAL IMPLANTATION WITH NO KNOWN CAUSE. NO FALL OR TRAUMA EVIDENT. 36 MM GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED. REPLACED WITH 40 MM GLENOSPHERE AND 40 MM + 3 STABILITY HUMERAL CUP AND 9 MM SPACER.

  Patient problems: Joint Dislocation

  MAUDE report 17965575 ↗
• InjuryMar 3, 2022Material Separation; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR DISMANTLING. APPROXIMATELY 3 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP (36/6) AND 1 CENTERED GLENOSPHERE (36). THE SURGEON IMPLANTED 1 HUMERAL CUP (40/6) AND 1 CENTERED GLENOSPHERE (40).

  Patient problems: Insufficient Information

  MAUDE report 13657909 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOLLOWING THE INITIAL SURGERY ON (B)(6) 2021 DUE TO DISASSOCIATION AS THE HUMERAL CUP GOT DISASSOCIATED FROM THE STEM. THE SURGEON EXPLANTED THE CENTERED GLENOSPHERE (36) AND HUMERAL CUP (36/6). THE SURGEON IMPLANTED THE CENTERED GLENOSPHERE (40) AND HUMERAL CUP (40/6).

  Patient problems: Joint Dislocation

  MAUDE report 13573081 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191146. One submission often covers many models, so check the product and lot details in each record.

• Z-0843-2024 · Aug 8, 2023 · Open, Classified
  Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210