MAUDE Adverse Event Report: LIMACORPORATE S.P.A. CURVED CUP IMPACTOR

Model Number	CURVED CUP IMPACTOR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The check of dhrs did not highlight any pre-existing anomalies.This is the first and only complaint received on this lot number.A final report will be submitted after the investigation is completed.
Event or Problem Description
During the procedure on (b)(6) 2026, the cup did not properly engage with curved cup impactor (product code: 9095.11.550, lot: 25bg084).This issue caused an approximate 20 minute delay.The instrument had been used approximately 10 times.The surgery was completed using the straight cup impactor without further complications.There was no impact on the patient.The instrument set had been checked by the scrub nurse and was used appropriately throughout the procedure.The surgeon is an experienced user of lima devices.The procedure performed was a primary tha.Event occurred in italy.

• Brand Name: CURVED CUP IMPACTOR
• Common Device Name: CURVED CUP IMPACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24763578
• Report Number: 3008021110-2026-00177
• Device Sequence Number: 9267443
• Product Code: MBL
• UDI-Device Identifier: 08033390104821
• UDI-Public: 08033390104821
• Combination Product (Y/N): N
• PMA/510(K) Number: K112898
• 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): 03/27/2026

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: CURVED CUP IMPACTOR
• Device Catalogue Number: 9095.11.550
• Device Lot Number: 25BG084
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/02/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown