PRIMA TT Glenoid 1974.09.040Recalls & reported problems
Limacorporate SPA · PRIMA TT Glenoid - Glenosphere Dia. 40 mm · Class 2 · Implant
All models of PRIMA TT Glenoid (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390231060), received between Jun 18, 2025 and Nov 6, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 Dislocated2
- Unstable1
Patient problems
- Joint Dislocation2
- Joint Laxity1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2025Unstable; Unstable
SHOULDER REVISION SURGERY DUE TO INSTABILITY PERFORMED ON (B)(6) 2025. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE FOLLOWING COMPONENTS WERE REMOVED: SMR REVERSE LINER +6MM D.40MM (PART CODE: 1365.50.820, LOT NUMBER: 22AT16B, STERILIZATION: 2200271). PRIMA GLENOSPHERE D.40 MM (PART CODE: 1974.09.040, LOT NUMBER: 2433271, STERILIZATION: 2500004). CONNECTOR W. SCREW LOW LAT.5MM (PART CODE: 1974.15.300, LOT NUMBER: 2320196, STERILIZATION: 2400132). ACCORDING TO THE INFORMATION RECEIVED, THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025, FOR A FRACTURE. THE SECOND REVISION ON (B)(6) 2025, WAS A PLANNED REVISION TO FINISH THE INTENDED CORRECTIONS FROM THE FIRST IMPLANT. THE SURGERY ON (B)(6) 2025 WAS DUE TO THE PATIENT DISLOCATION BECAUSE THE PREVIOUS REVISION DID NOT FULLY STABILIZE THE JOINT. THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1945. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Joint Laxity
MAUDE report 23484043 ↗InjuryJun 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO DISLOCATION. THE PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2025. A PRIMA STEM AND PRIMA TT GLENOID WERE IMPLANTED: PRIMA REVERSE TRAY #SHORT (PART CODE 1367.15.010, LOT NUMBER 2430342, STERILIZATION (B)(4). PRIMA REV. INSERT #SHORT D.40MM (PART CODE 1367.54.200, LOT NUMBER 23AT1BD, STERILIZATION (B)(4). PRIMA GLENOSPHERE D.40 MM (PART CODE 1974.09.040, LOT NUMBER 2424654, STERILIZATION (B)(4). CONNECTOR W. SCREW LOW LAT.5MM (PART CODE 1974.15.300, LOT NUMBER 2320196, STERILIZATION (B)(4). PATIENT BECAME UNSTABLE AND DISLOCATED IN SUBSEQUENT WEEKS. THE SURGEON REVISED ON (B)(6) AND INCREASED THE LATERALIZATION OF THE GLENOSPHERE FROM A MEDIUM TO A HIGH CONNECTOR. HE ALSO SWAPPED OUT THE PRIMA TRAY AND LINER AND UTILIZED A 7 DEGREE LINER TO GIVE INCREASE STABILITY. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1965. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Joint Dislocation
MAUDE report 22295860 ↗InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION. THE PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2024. DURING FOLLOW UP APPOINTMENTS, THE PATIENT WAS CONSIDERED UNSTABLE AND HAD EPISODES OF DISLOCATION. DURING THE REVISION SURGERY HEREBY REPORTED, THE FOLLOWING COMPONENTS WERE REMOVED: - PRIMA REVERSE TRAY #SHORT (PART CODE 1367.15.010, LOT NUMBER 2421221, STERILIZATION (B)(4)). - PRIMA REV.INSERT #SHORT D.40MM (PART CODE 1367.54.200, LOT NUMBER 23AT2TS, STERILIZATION (B)(4)). - PRIMA GLENOSPHERE D.40 MM (PART CODE 1974.09.040, LOT NUMBER 2424654, STERILIZATION (B)(4)). - CONNECTOR W. SCREW LOW LAT.5MM (PART CODE 1974.15.300, LOT NUMBER 2319371, STERILIZATION (B)(4)). THE 40 LOW GLENOSPHERE WAS SWAPPED TO A 36 HIGH OFFSET GLENOSPHERE. THE TRAY AND LINER WERE ALSO SWAPPED TO MATCH THE 36MM GLENOSPHERE. AN ADDITIONAL METHOD WAS USED TO ENSURE STABILITY: THE SURGEON IMPLANTED A DERMAL ALLOGRAFT TO STABILIZE THE CUFF ANTERIORLY. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1968. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Joint Dislocation
MAUDE report 22287424 ↗
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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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