MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SYSTEM - HUMERAL HEAD DIA. 54 MM

Model Number	1322.09.540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: the explanted components have been discarded and cannot be returned to the manufacturer for identification and analysis.Checking the manufacturing charts of the involved lot #1921272, no pre-existing anomalies were found on the components manufactured with the same lot #.Checking the manufacturing charts of the involved lot #2503636, no pre-existing anomalies were found on the components manufactured with the same lot #.A final mdr will be shared upon completion of the investigation.
Event or Problem Description
A shoulder revision surgery was performed on (b)(6) 2026 due to a failed hemi anatomic implant.The surgeon removed the anatomic head and adaptor and excised the superior edge of the glenoid.The cta head was re-implanted with the adaptor in the reverse position to allow greater contact with the glenoid rather than the acromion.The previous surgery was performed on (b)(6) 2025 and consisted of a revision for a failed "reverse" to hemi arthroplasty, however, the anatomic hemi construct ended up resting on the superior edge of the glenoid.The surgeon followed the standard surgical workflow for shoulder revision.The explanted components included: smr humeral head ø54 mm (product code 1322.09.540, lot 1921272, ster.N.2000414).Neutral adaptor taper standard (product code 1330.15.270, lot 2503636, ster.N.2500066).Patient is female, 76 years old.Event happened in australia.

• Brand Name: SMR SYSTEM - HUMERAL HEAD DIA. 54 MM
• Common Device Name: SMR SYSTEM - HUMERAL HEAD DIA. 54 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25688243
• Report Number: 3008021110-2026-00279
• Device Sequence Number: 4707317
• Product Code: KWT
• UDI-Device Identifier: 08033390274319
• UDI-Public: 08033390274319
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 1322.09.540
• Device Catalogue Number: 1322.09.540
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown