MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.50MM

Model Number	1322.09.500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2026 due to rotator cuff failure.Previous surgery occurred on (b)(6) 2021 for a total shoulder arthroplasty with smr anatomic components: glenoid metal back std (pn 1375.21.010, lot 2100627, sterilization 2100093).Liner for metal back std (pn 1377.50.010, lot 20at3k4, sterilization 2100083).Finner stem dia20mm (pn 1304.15.200, lot 1804199, sterilization 1800137).Finned humeral body (pn 1350.15.110, lot 2022509, sterilization 2100045).Adaptor taper eccentrical (pn 1331.15.274, lot 2016589, sterilization 2100139).Humeral head dia50 (ppn 1322.09.500, lot 1503172, sterilization 2100045).Due to rotator cuff failure, the original implant has been converted to a reverse configuration removing the above-mentioned humeral head, adaptor taper and liner for metal back and replacing them with: connector+ screw small std (pn 1374.15.310).Glenosphere dia36mm (pn 1374.09.111).Reverse humeral body (pn 1352.15.010).Extension for reverse humeral body (pn 1352.15.001).Reverse liner standard (pn 1360.50.810).Surgery was completed as intended.Patient is male, date of birth (b)(6) 1951.The event occurred in the united states.
Additional Manufacturer Narrative
Preliminary review of manufacturing and sterilization records did not highlight any pre-existing non-conformity relevant to the issue.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.50MM
• 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: 25278189
• Report Number: 3008021110-2026-00222
• Device Sequence Number: 10060627
• Product Code: KWT
• UDI-Device Identifier: 08033390001410
• UDI-Public: 8033390001410
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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: 1322.09.500
• Device Lot Number: 1503172
• 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: 74 YR
• Patient Sex: Male