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

Model Number	1379.50.030
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Osteolysis (2377); Joint Laxity (4526)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.No review of manufacturing records for complained parts can be performed either since lot number is unknown.No x-rays nor pictures of explanted components were provided either.From follow-up communication with complaint source it was confirmed that no further information regarding the case can be retrieved, therefore no further root cause investigation is possible.Taking into account the involved product family smr shoulder, no adverse trend has been identified for reported issue in the last year.According to investigation carried out, no corrective action is needed for this event.If any additional information is received that would change or alter any conclusion, a supplemental report will be filed accordingly.The manufacturer will continue monitoring the market in order to detect any similar event.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to loosening.Patient underwent primary surgery at unknown date, prior to hospital digital record system implementation, therefore no information regarding original implant could be retrieved.Original implant was reported to be and assembly of smr humeral components (trauma humeral body pn (b)(4), eccentrical adaptor taper pn (b)(4), humeral head dia50mm pn (b)(4) and large 3-pegged cemented glenoid (pn (b)(4)).Due to implant loosening over time, osteolysis caused significant amount of glenoid bone loss.Reportedly, patient engaged in weightlifting, possibly contributing to reported loosening.Components were removed and demineralized bone matrix and cancellous bone chips were used to graft in the glenoid.New humeral body (pn (b)(4)) , adapter (pn 1330.15.272), and humeral head (pn (b)(4)) were implanted for a hemi arthroplasty, until a second procedure can be undergone in the future to implant a baseplate.Surgery was completed as intended.Patient is male, date of birth (b)(6) 1959.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: SMR 3-PEGS GLENOID - LARGE
• 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: 24210830
• Report Number: 3008021110-2026-00090
• Device Sequence Number: 14810408
• Product Code: KWS
• UDI-Device Identifier: 08033390114004
• UDI-Public: 8033390114004
• Combination Product (Y/N): N
• PMA/510(K) Number: K153722
• 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): 01/29/2026

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: 1379.50.030
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• 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