MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; ECCENTRICAL ADAPTOR TAPERS +2MM, STANDARD

Model Number	1330.15.272
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the components involved in the event, no pre-existing anomaly was found on the items belonging to the same part codes and lot numbers as the components removed during the revision surgery hereby reported.We will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to disassembly of components.The morse taper connection disengaged.The following components were removed: smr finned stem short d.21 (part code: 1304.15.021, lot number: 2016623, sterilization 2000409).Smr humeral head dia.54 mm (part code: 1322.09.540, lot number: 1506372, sterilization 2000414).Smr ecc.Adaptor taper standard (part code: 1330.15.272, lot number: 2331971, sterilization 2400033).Smr finned humeral body (part code: 1350.15.110, lot number: 2101472, sterilization 2100098).The above-mentioned components were replaced by the following new ones: smr finned stem dia 21mm l.80 (part code: 1304.15.210, lot number: 2320690, sterilization 2400025).Smr finned humeral body (part code: 1350.15.110, lot number: 2405095, sterilization 2400062).Smr ecc.Adaptor taper 2mm (part code: 1330.15.272, lot number: 2414583, sterilization 2400152).Smr humeral head dia.54 mm (part code: 1322.09.540, lot number: 1503494, sterilization 2000263).Previous surgery took place on (b)(6) 2025.The patient is a male, date of birth on (b)(6) 1972.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: ECCENTRICAL ADAPTOR TAPERS +2MM, STANDARD
• 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: 21932973
• Report Number: 3008021110-2025-00040
• Device Sequence Number: 13017345
• Product Code: KWT
• UDI-Device Identifier: 08033390001922
• UDI-Public: 08033390001922
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1330.15.272
• Device Lot Number: 2331971
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• 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