MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION; UNCEMENTED STEM DIA=14MM - L=140MM

Model Number	3810.15.010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No pre-existing anomalies were detected by the check of the manufacturing records of the (b)(4) stems release with lot n.2400816.This is the first and only complaint recorded on this lot n.A final report will be submitted after the conclusion of the investigation.
Event or Problem Description
Intra operative issue occurred on (b)(6) 2026 during hip surgery: the surgeon prepared the femur canal with the reamer revision - reamer dia.13mm (code 9038.10.515, lot unknown) and implanted the revision mod.Stem ø14mm (code 3810.15.010, lot 2400816, ster.2400048).The stem did not stay in the medullary canal (it appeared to be smaller than the rasp).A prosthesis from a different manufacturer was then implanted.Due to this issue, there were 40 minutes of delay to complete the surgery.This event occurred in germany.

• Brand Name: REVISION
• Common Device Name: UNCEMENTED STEM DIA=14MM - L=140MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25704028
• Report Number: 3008021110-2026-00265
• Device Sequence Number: 18572034
• Product Code: KWY
• UDI-Device Identifier: 08033390003841
• UDI-Public: 08033390003841
• Combination Product (Y/N): N
• PMA/510(K) Number: K151739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/02/2026

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: 3810.15.010
• Device Lot Number: 2400816
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown