MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; METAL-BACK (TI6AL4V + POROTI) METAL-BACK STANDARD

Model Number	1375.21.010
Medical Device Problem Codes	Unstable (1667); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Joint Laxity (4526); Loose body in joint (4926)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.No review of manufacturing records for complained parts can be performed either since lot number is unknown.No x-rays nor pictures of explanted components were provided either.From follow-up communication with complaint source it was confirmed that no further information regarding the case can be retrieved, therefore no further root cause investigation is possible.Taking into account the involved product family smr shoulder, no adverse trend has been identified for reported issue in the last year.According to investigation carried out, no corrective action is needed for this event.If any additional information is received that would change or alter any conclusion, a supplemental report will be filed accordingly.The manufacturer will continue monitoring the market in order to detect any similar event.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to loosening.The glenoid component was loose, causing instability.Previous surgery is unknown, as well as complete product information of original implant.During revision the surgeon opted to take out all glenoid components: - smr metal-back glenoid std (part number 1375.21.010), - smr eccent.Glenosphere ø 40mm (part number 1376.09.041), - two bone screw ø6,5 h.35mm (part number 8420.15.040).And replaced the existing smr reverse humeral body (part number 1352.15.010) and smr reverse liner +6mm d.40mm (part number 1365.50.820) to improve exposure of the glenoid during surgery.Subsequently a depuy enhance glenoid baseplate was implanted along with a 40mm glenosphere, while on the humeral side a new smr humeral body (pn 1352.15.010) with extension for humeral reverse body (pn 1352.15.001) and reverse liner retentive +6mm dia40mm (pn 1365.50.821) were implanted.Surgery was completed as intended.Patient is male, date of birth (b)(6) 1936.The event occurred in united states.

• Brand Name: SMR SHOULDER
• Common Device Name: METAL-BACK (TI6AL4V + POROTI) METAL-BACK STANDARD
• 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: 24210831
• Report Number: 3008021110-2026-00089
• Device Sequence Number: 12120384
• Product Code: PHX
• UDI-Device Identifier: 08033390273350
• UDI-Public: 8033390273350
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 01/29/2026

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: 1375.21.010
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• 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 Sex: Unknown