Titan Reverse Shoulder System GLS-0961-05C-SRecalls & reported problems
Smith & Nephew, Inc. · RSS GLENOSPHERE. CONCENTRIC-S. 5MM · Class 2 · Implant
All models of Titan Reverse Shoulder System (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556863817), received between Aug 11, 2023 and Oct 14, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Migration1
Patient problems
- Joint Dislocation3
- Failure of Implant1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2024Migration; Migration
IT WAS REPORTED THAT FOLLOWING A REVERSE ARTHROSCOPY OF THE RIGHT SHOULDER PERFORMED ON (B)(6) 2019, THE GLENOSPHERE COMPONENT WAS FOUND TO BE DISLOCATED FROM THE GLENOID BASEPLATE SEEN ON X-RAYS EVALUATION AT FIRST POSTOPERATIVE VISIT ON (B)(6) 2019 AS THE PATIENT WAS ASYMPTOMATIC. THEREFORE, REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO CORRECT THIS BY EXPLANTING THE GLENOSPHERE, THE LINER, AND THE PERIPHERAL SCREW 4 TO REPLACE THEM WITH NEW COMPONENTS. OUTCOME RESOLVED WITHOUT SEQUELAE ON PATIENT.
Patient problems: Joint Dislocation
MAUDE report 20447068 ↗InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A TSA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED A DISASSOCIATION OF THE RSS GLENOSPHERE AND THE BASE PLATE. THIS ADVERSE EVENT WAS SOLVED VIA A REVISION SURGERY ON (B)(6) 2023 DURING WHICH THE GLENOSPHERE AND THE LINER WERE EXPLANTED AND EXCHANGED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 17608190 ↗InjuryAug 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A PRIMARY LEFT RTSA THAT TOOK PLACE ON (B)(6) 2023, A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2023 DUE TO A DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. DURING REVISION, A RSS GELNOSPHERE, 5MM CONCENTRIC AND A RSS HXL LINER RETENTIVE +3R WERE EXPLANTED AND REPLACED WITH SAME SIZE OF NEW SMITH AND NEPHEW BACK-UP DEVICES. THE INITIALLY IMPLANTED RSS GLENOID BASEPLATE-S WAS RETAINED. CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 17598220 ↗InjuryAug 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A RIGHT RTSA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT ATTENDED CLINIC ON (B)(6) 2023 WHERE THE SURGEON DETERMINED THAT THE GLENOSPHERE HAD DISSOCIATED FROM THE BASEPLATE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE GLENOSPHERE AND LINER IMPLANTS WERE REMOVED. THE SURGEON ALSO REMOVED ANY BONE SURROUNDING THE BASEPLATE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 17515272 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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