MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.52MM

Model Number	HUMERAL HEAD
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery of a smr anatomic prosthesis performed on (b)(6) 2025, due to cuff failure.It was reported that the subscapularis has failed 10 years post primary surgery.The following devices were removed and the prosthesis was converted to reverse configuration: smr humeral head ø52 mm (product code: 1322.09.520, lot#: 1500216 - ster.1500066).Smr cementless finned stem (product code: 1304.15.220, lot#: 1414382 - ster.1500033).Smr eccentric adaptor taper standard (product code: 1330.15.278, lot#:1502057 - ster.1500122).Smr trauma humeral body# short (product code: 1350.15.030, lot#: 1003333 - ster.1500245).Cemented glenoid 3 pegs standard (product code 1379.51.010, lot#: 14l0379 - ster.1400294).According to the received information, all components were removed due to the primary implants being in too high.Previous surgery took place on (b)(6) 2015.Patient is a male, 67 years old.Event happened in new zealand.
Additional Manufacturer Narrative
Checking the dhrs of the involved lot#: 1500216, no pre-existing anomaly was found on the 60 devices manufactured with that lot#.According to our records, at least 46 humeral heads belonging to lot#: 1500216 and ster.1500066 have been implanted and this is the only complaint received on this lot#.Device analysis: devices involved were not returned to limacorporate for further analysis.No additional details were available on this event, specifically pre-operative x-rays weren't accessible.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that the check of manufacturing charts highlighted no anomalies on the components manufactured with the involved lot#: 1500216, the subscapularis has failed, and that the survivorship of the prosthesis is of about 10 years, we can state that the event is not product related.Pms data: according to limacorporate pms data, the revision rate of smr anatomic prosthesis (total and hemi) due to cuff failure is (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate continues monitoring the market to promptly detect any similar issue.Note: this is a combined initial-final mdr.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.52MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 21688255
• Report Number: 3008021110-2025-00032
• Device Sequence Number: 12966773
• Product Code: KWT
• UDI-Device Identifier: 08033390001427
• UDI-Public: 08033390001427
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 03/24/2025

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 HEAD
• Device Catalogue Number: 1322.09.520
• Device Lot Number: 1500216
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2025
• 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