MAUDE Adverse Event Report: LimaCorporate S.p.A Stem Positioner; Stem Positioner - Master SL & Minima S

Model Number	9045.03.300
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Malfunction

• Brand Name: Stem Positioner
• Common Device Name: Stem Positioner - Master SL & Minima S
• Manufacturer (Section D): LimaCorporate S.p.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 50913949
• Report Number: 3008021110-2026-00394
• Device Sequence Number: 5999020
• Product Code: LZO
• UDI-Device Identifier: 08033390084543
• UDI-Public: 08033390084543
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K140975
• 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: 9045.03.300
• Device Catalogue Number: 9045.03.300
• 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: 09/28/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown