MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PRIMA; PRIMA - REVERSE INSERT # SHORT DIA.40MM 0° CORR

Model Number	1367.54.200
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery was performed on (b)(6) 2023 for dislocation.Patient dislocated post op and cause was a stretched-out shoulder capsule.Device was revised to a thicker component.Revision was a success with no complications.Agent stated patient anatomy is suspected but the devices did not fail.Previous surgery - (b)(6) 2023.Patient - male.Date of birth - (b)(6).Event happened in usa.Explanted components.Prima reverse tray #short, commercial code 1367.15.010 - lot #2308370 - ster.#2300107.Prima rev.Insert #short d.40mm, commercial code 1367.54.200 - lot #23at1be - ster.#2300147.
Additional Manufacturer Narrative
Checking the dhr's of the components involved in this complaint, no anomaly was found.Therefore, we can conclude that the products have been correctly manufactured before being placed on the market.Will submit final mdr when investigation is completed.
Additional Manufacturer Narrative
Investigation: checking the dhr's of the components involved in this complaint, no anomaly was found.Therefore, we can conclude that the products have been correctly manufactured before being placed on the market.The explanted components were not available for return for investigation.X-rays were requested but not available.However, according to the information received by the complaint source, the agent stated that patient anatomy is suspected but the devices did not fail.Therefore, considering that: - no anomaly was found by checking the dhrs of the components involved in this event.- agent stated patient anatomy is suspected but the devices did not fail.We have no evidence to consider the event as product related.Pms analysis: according to the available pms data, the revision rate of prima reverse inserts belonging to the family product code 1367.54.Xxx due to implant dislocation/luxation is around 0.2% based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issues.Note: this is a final mdr.
Event or Problem Description
Shoulder revision surgery was performed on (b)(6) 2023, for dislocation and suspected cuff failure.Patient dislocated post-operatively and the cause was a stretched-out shoulder capsule.The following devices were removed and revised by new components (size #medium): - prima reverse tray #short (part code 1367.15.010, lot number 2308370, sterilization (b)(4)).- prima rev.Insert #short d.40mm (part code 1367.54.200, lot number 23at1be, sterilization (b)(4)).The other components previously implanted (on (b)(6) 2023) were left in situ: - prima stem #4 - ti6al4v (part code 1357.14.034, lot number 2225296, sterilization (b)(4)).- smr glenosphere ø 40mm (part code 1374.09.121, lot number 2300889, sterilization (b)(4)).- smr connector small r (part code 1374.15.305, lot number 2307421, sterilization (b)(4)).- smr glenoid peg tt small-r #m (part code 1375.14.652, lot number 2313252, sterilization (b)(4)).- tt augm.360 baseplate #s-r+4mm (part code 1375.15.524, lot number 2221892, sterilization (b)(4)).Revision was a success with no complications.The patient is a male, date of birth (b)(6) 1953.The event happened in the united states.

• Brand Name: PRIMA
• Common Device Name: PRIMA - REVERSE INSERT # SHORT DIA.40MM 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: 18266826
• Report Number: 3008021110-2023-00128
• Device Sequence Number: 12735317
• Product Code: PHX
• UDI-Device Identifier: 08033390203340
• UDI-Public: 08033390203340
• Combination Product (Y/N): Y
• PMA/510(K) Number: K212800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 1367.54.200
• Device Lot Number: 23AT1BE
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 09/10/2025
• 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: 69 YR
• Patient Sex: Male