PRIMA TT GlenoidRecalls & reported problems across all models
Limacorporate SPA · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one PRIMA TT Glenoid model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 3
We found 16 models of PRIMA TT Glenoid by Limacorporate SPA in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between May 25, 2023 and Sep 21, 2026 — classified as 4 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (6 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PRIMA TT Glenoid recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 29, 2023Open, Classified
Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
Z-0726-2024 · Root cause: Device Design · names 10 of these models · Recall details · FDA record ↗
- May 30, 2023Open, Classified
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Z-2010-2023 · Root cause: Device Design · Recall details · FDA record ↗
- May 30, 2023Open, Classified
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Z-2009-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported PRIMA TT Glenoid problems
Device problems
- Mechanical Problem6
- Device Dislodged or Dislocated2
- Material Integrity Problem1
- Patient Device Interaction Problem1
- Product Quality Problem1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Joint Dislocation2
- Implant Pain1
- Insufficient Information1
- Joint Laxity1
PRIMA TT Glenoid models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PRIMA TT Glenoid 1975.14.500Shoulder Prosthesis, Reverse Configuration2 recalls0 reports
- PRIMA TT Glenoid 1975.14.800Shoulder Prosthesis, Reverse Configuration2 recalls0 reports
- PRIMA TT Glenoid 1975.14.615Shoulder Prosthesis, Reverse Configuration1 recall1 report
- PRIMA TT Glenoid 1975.14.510Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.620Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.810Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.815Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.820Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.865Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.870Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1974.09.040Shoulder Prosthesis, Reverse Configuration3 reports
- PRIMA TT Glenoid 9019.74.140Shoulder Prosthesis, Reverse Configuration3 reports
- PRIMA TT Glenoid 1975.15.594Shoulder Prosthesis, Reverse Configuration1 report
- PRIMA TT Glenoid 9019.74.300Shoulder Prosthesis, Reverse Configuration1 report
- PRIMA TT Glenoid 9019.74.301Shoulder Prosthesis, Reverse Configuration1 report
- PRIMA TT Glenoid 9019.74.152Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 report
Recent PRIMA TT Glenoid adverse event reports
The 11 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840364 ↗MalfunctionSep 21, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839855 ↗MalfunctionApr 27, 2026Mechanical Problem
THE COMPLAINT SOURCE REPORTED THAT DURING A SHOULDER SURGERY PERFORMED ON (B)(6) 2026, IT WAS NOT POSSIBLE TO INSERT THE GLENOSPHERE INTO THE GLENOSPHERE PUSHER (PRODUCT CODE: 9019.74.152 - LOT NR: UNKNOWN) DESIGNED FOR THIS PURPOSE. THIS MALFUNCTION ADDED APPROXIMATELY 30 MINUTES TO THE PROCEDURE. EVENT OCCURRED IN FRANCE.
Patient problems: Insufficient Information
MAUDE report 24995512 ↗MalfunctionJan 30, 2026Mechanical Problem
DURING SURGERY ON (B)(6) 2025 THE THREAD OF THE GLENOSPHERE EXTRACTOR INSTRUMENT (PRODUCT CODE: 9019.74.140; LOT NUMBER: UNKNOWN) DID NOT ENGAGE WITH THE GLENOSPHERE (PRODUCT CODE: 1974.54.440; LOT NUMBER: 2424139) AND THEREFORE COULD NOT BE USED TO EXTRACT THE GLENOSPHERE. THE SURGEON REMOVED THE GLENOSPHERE BY USING A HOOK TO TAP IT OUT AND THEN IMPLANTED A NEW GLENOSPHERE TO COMPLETE THE PROCEDURE. THE SURGICAL TIME WAS PROLONGED BY APPROXIMATELY 15 MINUTES DUE TO THIS ISSUE. EVENT OCCURRED IN SWITZERLAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24222954 ↗MalfunctionDec 2, 2025Product Quality Problem; Product Quality Problem
DURING SURGERY, TWO SEPARATE PACKAGES OF LOCKING CAPS (PRODUCT CODE: 1975.15.594, LOT: 2434865 - STER: 2500040) WERE OPENED, BUT THE CAPS COULD NOT BE APPLIED DUE TO FAILURE OF THE ANGLE-STABLE LOCKIAG MECHANISM. THAT ISSUE PREVENTED PROPER FIXATION. THE PROCEDURE COULD NOT BE CARRIED OUT AS PLANNED BECAUSE THE ANGULAR-STABLE CAPS COULD NOT BE IMPLANTED DUE TO THE ISSUE ON CAP CLOSURE. THIS RESULTED IN A DELAY OF APPROXIMATELY 15-20 MINUTES. THE DEVICES HAVE BEEN DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692503 ↗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 ↗InjuryAug 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
SHOULDER REVISION SURGERY DUE TO LOOSENING OF THE GLENOID COMPONENT PERFORMED ON (B)(6) 2025. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6), FEW WEEKS LATER, THE PATIENT SHOWED UP IN CLINIC COMPLAINING OF PAIN. SHE DIDN'T DESCRIBE AN INCIDENT. THE X-RAYS REVEALED LOOSE GLENOID COMPONENT. ON (B)(6), THE SURGEON REVISED THE PATIENT WITH BONE GRAFTING AND REPLACING THE GLENOID. SIGNIFICANT BONE LOSS WAS NOTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. THE BASEPLATE INVOLVED IN THE COMPLAINT IS THE FOLLOWING: BASEPLATE D.25MM FULL WEDGE15°, PRODUCT CODE 1975.14.615, LOT N. 2435904, STER. (B)(4). THE PATIENT IS FEMALE, BORN IN 1945. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Implant Pain
MAUDE report 22687144 ↗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 ↗MalfunctionJan 7, 2025Mechanical Problem; Mechanical Problem
INTRA-OPERATIVE ISSUE OCCURRED DURING A PRIMA TT IMPLANT SURGERY PERFORMED ON (B)(6) 2024. AFTER IMPLANTING A GLENOSPHERE TRIAL 36 MEDIUM, THE SURGEON WENT THROUGH RANGE OF MOTION AND WAS NOT HAPPY. HE DECIDED TO REMOVE GLENOSPHERE TO TRIAL A 40 MEDIUM. AFTER REMOVING THE SET SCREW FOR GLENOSPHERE, HE INSERTED THE TAPER BREAKER OF THE FOLLOWING INSTRUMENT: CONNECTOR POSITIONER/EXTRACTOR (PART CODE 9019.74.301, LOT NUMBER 24BH00Q). THE NARROW ROD FOR TAPER BREAKER GOT STUCK ON THE IMPLANT AND COULD NOT BE REMOVED. HE HAD TO DISASSEMBLE THE TAPER BREAKER TO REMOVE THE GLENOSPHERE AND ROD IN SEPARATE PIECES. AFTER REMOVING THE GLENOSPHERE, IT WAS NOTED THAT THE MEDIUM CONNECTOR WAS LEFT BEHIND. THE SURGEON ATTEMPTED TO USE THE NEW REMOVAL DEVICE FROM THE TRAY, BUT EVERY TIME IT WAS LOCKED IN PLACE THE BREAKER ROD WAS INSERTED, THE DEVICE DISCONNECTED FROM THE IMPLANT. THIS WAS ATTEMPTED SEVERAL TIMES WITH THE SAME RESULT. EVENTUALLY, AFTER WASTING ABOUT 10 MINUTES OF OR TIME, THE SURGEON DECIDED TO IMPLANT A 40 GLENOSPHERE ON TOP OF THE MEDIUM CONNECTOR. TAPER DID NOT APPEAR TO BE DAMAGED ON THE INSIDE, SO HE FELT COMFORTABLE IMPLANTING A NEW GLENOSPHERE INTO IT. THE PATIENT IS A MALE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21090855 ↗MalfunctionMay 25, 2023Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem
DURING REVISION SHOULDER SURGERY PERFORMED ON (B)(6) 2023, THE SURGEON ATTEMPTED TO REMOVE A ADAPTER COMPONENT WITH THE INSTRUMENT CONNECTOR EXTRACTOR, COMMERCIAL CODE 9019.74.300 - LOT #22AQ2ME. THE INSTRUMENT WOULD NOT SEPARATE MORSE TAPER OF THE ADAPTER FROM BASEPLATE. FIX WAS TO REPLACE LINER WITH CONSTRAINED LINER. THIS RESULTED IN A SURGERY DELAY OF 20 MINUTES. HOWEVER, NO CONSEQUENCES HAVE BEEN EXPERIENCED FOR THE PATIENT. PATIENT - MALE. BIRTH DATE - (B)(6) 1944. EVENT HAPPENED IN U.S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17002142 ↗
Other Limacorporate SPA products
All Limacorporate SPA devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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