MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.52MM

Model Number	1322.09.520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore are not available for identification and analysis.Review of manufacturing records cannot be performed since lot number are unknown.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to rotator cuff failure.Prevuous surgery is unknown, as well as complete product information of original implant.During revision the surgeon explanted the pre-existing tt hybrid cem.Glenoid std low (part number 1379.59.200), smr humeral body (pn1350.15.010), smr ecc.Adaptor taper std +2m (part number 1330.15.272) and the smr humeral head d.52 mm (part number 1322.09.520) and converted the prosthesis to a reverse configuration using following components: tt hybrid reverse baseplate std (pn 1379.15.170), glenosphere dia40 (pn 1374.09.121), 140° reverse humeral body (pn 1352.15.011), extension for humeral reverse body (pn 1352.15.001), reverse liner std dia40 (pn 1365.50.810)., the distal portion of the smr construct was left in patient for the conversion since it was well fixed and intact.Surgery was completed as intended.Patient is male, date of birth (b)(6) 1953.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.52MM
• 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: 25297978
• Report Number: 3008021110-2026-00228
• Device Sequence Number: 21155761
• Product Code: KWT
• UDI-Device Identifier: 08033390274296
• UDI-Public: 8033390274296
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• 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): 05/27/2026

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: 1322.09.520
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• 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: 72 YR
• Patient Sex: Male