MAUDE Adverse Event Report: LIMACORPORATE S.P.A PRIMA HUMERAL SYSTEM; PRIMA REVERSE INSERT # SHORT DIA.36MM 0° CORR.

Model Number	1367.54.100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to shoulder dislocation.Original surgery was performed on the same day to implant a combination of following prima humeral components and djo altivate reverse glenoid: prima short stem plus #1 (pn 1357.14.228, lot 2524131, sterilization (b)(6)) prima reverse tray #short (pn 1367.15.010, lot 2518444, sterilization (b)(6)) prima limavit reverse insert #short dia 36mm corr 0° (pn 1367.54.100, lot 25at2re, sterilization (b)(6)).Djo modular baseplater and taper kit (pn 508-65-001).Djo rsp glenoid head and retaining screw 2mm lateral offset sz 36mm (pn 508-36-103).Patient dislocated and the above mentioned prima reverse tray and liner were replaced: same size of tray was chosen by surgeon, while the new liner was replaced with a retentive one (pn 1367.54.101).Surgery was completed as intended.Patient is male, date of birth (b)(6) 1957.The event occurred in the united states.
Additional Manufacturer Narrative
Review of manufacturing records did not identify any pre-existing anomaly or non conformity that could have contributed to reported issue.From follow-up communication the complaint source confirmed that surgeon tested the stability of the assembly during original surgery, with no issues reported.Moreover, the explanted components were reported to be in good condition when explanted, thus excluding an early failure of the components causing the issue.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: PRIMA HUMERAL SYSTEM
• Common Device Name: PRIMA REVERSE INSERT # SHORT DIA.36MM 0° CORR.
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 25067086
• Report Number: 3008021110-2026-00197
• Device Sequence Number: 18731374
• Product Code: PHX
• UDI-Device Identifier: 08033390202954
• UDI-Public: 8033390202954
• Combination Product (Y/N): N
• PMA/510(K) Number: K212800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1367.54.100
• Device Lot Number: 25AT2RE
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male