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	Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefor eare not available for identification and analysis.Lot number are unknown therefor eno review of manufacturing records can be performed.From follow-up communication it was learned that the components appeared in good condition when explanted and the implant most likely lasted around 8-10 years before failing.The surgeon who revised the shoulder prosthesis inferred that the implant was positioned high in the glenoid.According to sales representative present, possible contribution of patient bone loss cannot be excluded as well.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery performed on (b)(6) 2026 because of glenoid components failure due to bad placement.Previous surgery is unknown, as well as complete product information of original implant.During revision the pre-existing metal back glenoid std (pn 1375.21.010), glenosphere eccentrical dia36mm (pn 1376.09.030) and smr reverse liner standard (pn 1360.50.810) were removed and the assembly was converted to a hemiarthroplasty with an adaptor 36mm for reverse body (pn 1352.15.200) and cta head dia50mm (pn 1323.09.500).Surgery was completed as intended.Patient is female, date of birth (b)(6) 1951.The event occurred in the 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: 25278198
• Report Number: 3008021110-2026-00224
• Device Sequence Number: 10023917
• 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 Age: 75 YR
• Patient Sex: Female