MAUDE Adverse Event Report: LimaCorporate S.p.A SMR Shoulder system; Stem Extractor

Model Number	9013.02.301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the involved lot#: 14aa150a, no pre-existing anomalies were found on the 50 devices manufactured with the same lot#.A final mdr will be shared upon completion of the investigation.
Event or Problem Description
During an smr revision performed on (b)(6) 2026, an intraoperative issue occurred.While the humeral components were being removed using the stem extractor, the extractor was struck with a mallet to remove the stem.During this maneuver, the threaded portion of the extractor broke and remained lodged inside the stem.The event resulted in an approximately 20-minute delay to the surgical procedure.The surgeon followed the standard surgical workflow for shoulder revision.The involved instrument was: smr - stem extractor (product code 9013.02.301, lot 14aa150a).Event happened in australia.

• Brand Name: SMR Shoulder system
• Common Device Name: Stem Extractor
• Manufacturer (Section D): LimaCorporate S.p.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 50729553
• Report Number: 3008021110-2026-00368
• Device Sequence Number: 13427449
• Product Code: HWB
• UDI-Device Identifier: 08033390097987
• UDI-Public: 08033390097987
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: Class I
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial

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: 9013.02.301
• Device Catalogue Number: 9013.02.301
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown