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 Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 because of failure of reverse shoulder assembly due to malalignment.Previous surgery is unknown, as well as complete product information of original prosthesis.During revision, the original metal back (pn 1375.21.010) and glenosphere dia36mm (pn 1376.09.030) were removed, as well as reverse liner standard (pn 1360.50.810), to be replaced with different manufacturer reverse glenoid assembly.Surgery was completed as intended.Patient is female.The event occurred in the united states.
Additional Manufacturer Narrative
Involved components have been discarded therefore are not available for identification and inspection.Since lot number is unknown, review of manufacturing records cannot be performed.The manufacturer will submit a final report as soon as the investigation is completed.

• 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: 25275493
• Report Number: 3008021110-2026-00216
• Device Sequence Number: 21254092
• Product Code: KWS
• UDI-Device Identifier: 08033390273350
• UDI-Public: 8033390273350
• Combination Product (Y/N): N
• PMA/510(K) Number: K113254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/26/2026

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: 05/26/2026
• 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: Female