MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.18MM

Model Number	1304.15.180
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore they are not available for identification and investigation.Lot number is unknown thus review of manufacturing records cannot be performed.The manufacturer will provide a final report as soon as the investigation is completed.
Event or Problem Description
Second stage revision surgery was performed on january 6th 2026 in a two stage revision.Original surgery is unknown, as well as first stage revision surgery date and reason.Patient originally had a lima anatomic shoulder prosthesis with cemented 3-pegged glenoid.Prior revision was performed to remove glenoid and the defect was packed with bone graft.During current revision, the surgeon attempted to convert the prosthesis to a reverse configuration explanting the original smr trauma hum.Body # medium (part number 1350.15.010), neutral adaptor taper standard ((part number 1330.15.270) and smr humeral head ø48 mm (part number 1322.09.480), but the reverse body was deemed to be too proud to reduce the shoulder, therefore the smr cementless finned stem (part number 1304.15.180) was replaced with a tornier revive stem.Prima tt components were successfully implanted on the glenoid side.The patient is male, date of birth (b)(6) 1946.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.18MM
• 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: 24442715
• Report Number: 3008021110-2026-00122
• Device Sequence Number: 21423626
• Product Code: HSD
• UDI-Device Identifier: 08033390270816
• UDI-Public: 8033390270816
• Combination Product (Y/N): N
• PMA/510(K) Number: K101263
• 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): 02/25/2026

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: 1304.15.180
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• 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: 79 YR
• Patient Sex: Male