MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; SMR 3-PEGS SMALL

Catalog Number	1379.50.020
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Parts have been discarded therefore cannot be returned to manufacturer for identification and investigation.No review of manufacturing records for complained part is therefore possible.The manufacturer will provide a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to loosening of the cemented glenoid.Patient had a prior anatomic shoulder with cemented 3-pegged poly (part number 1379.50.020, lot unknown).After loosening of the poly glenoid was detected in a clinic visit, a two-staged revision was planned.During revision surgery, 3-pegged cemented poly was removed and the void in glenoid was filled with bone graft.A new humeral head (part number 1324.09.461) and adapter (part number 1330.15.270) of the same size were implanted for renewal reasons, but no defect were reported on original humeral components.Humeral body was indeed retained.Previous surgery date is unknown.Patient is female, date of birth (b)(6) 1962.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: SMR 3-PEGS SMALL
• 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: 23943074
• Report Number: 3008021110-2026-00002
• Device Sequence Number: 10725161
• Product Code: KWS
• UDI-Device Identifier: 08033390096362
• UDI-Public: 8033390096362
• Combination Product (Y/N): N
• PMA/510(K) Number: K130642
• 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): 01/02/2026

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 Catalogue Number: 1379.50.020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2026
• 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 Sex: Unknown