MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; TRAUMA HUMERAL BODIES WITH LOCKING SCREW SHORT

Model Number	HUMERAL BODY
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lot #1601336, no pre-existing anomaly was found on the 3 devices manufactured with the same lot # - ster.This is the first and only complaint received on that lot #.We submit a final mdr when the investigation is complete.
Event or Problem Description
Shoulder revision surgery of a smr anatomic hemi prosthesis performed on (b)(6)2025, due to poor bone quality.This is a second stage revision surgery: it was reported that the patient had a prior anatomic shoulder with a cemented 3-pegged poly glenoid (product code and lot # unknown).The patient was revised and the cemented poly glenoid was removed (date of the surgery unknown).The glenoid was packed with a bone graft and left to heal for the second stage revision.At the time, an anatomic humeral body and a humeral head were implanted, and the patient was left with the hemi prosthesis.Upon inspection of the glenoid on the surgery of (b)(6) 2025, the bone quality was deemed too poor to proceed to a reverse baseplate.The following devices were explanted: · smr trauma humeral body # short (product code 1350.15.030, lot #1601336 - ster.(b)(4)).· smr humeral head d.44 h.14mm (product code 1321.09.441, lot #2014027 - ster.(b)(4)).· neutral adaptor taper standard (product code 1330.15.270, lot #2014099 - ster.(b)(4)).The same size components were put back in and the patient will have a hemi for the foreseeable future.Patient is a female, 81 years old.Poor bone quality reported.Event happened in the us.

• Brand Name: SMR SHOULDER
• Common Device Name: TRAUMA HUMERAL BODIES WITH LOCKING SCREW SHORT
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 21993924
• Report Number: 3008021110-2025-00054
• Device Sequence Number: 14518874
• Product Code: HSD
• UDI-Device Identifier: 08033390002028
• UDI-Public: 08033390002028
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 05/09/2025

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: HUMERAL BODY
• Device Catalogue Number: 1350.15.030
• Device Lot Number: 1601336
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2025
• 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 Sex: Unknown