MAUDE Adverse Event Report: LIMACORPORATE S.P.A. MODULUS FEMORAL STEM; MANUAL IMPACTOR

Model Number	9043.10.310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026 during a planned hip revision surgery, involving one tt with modulus r, the manual impactor (product code:9043.10.310 - lot: unknown) fractured during trialing with a size 23 trial stem, after femoral preparation with reamers.The extraction of the trial stem was difficult.The procedure was completed by implanting a revision stem, available on consignment at the hospital.Event occurred in italy.
Additional Manufacturer Narrative
No review of manufacturing records for complained parts can be performed either since lot number/product information is unknown.

• Brand Name: MODULUS FEMORAL STEM
• Common Device Name: MANUAL IMPACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25169993
• Report Number: 3008021110-2026-00232
• Device Sequence Number: 10138111
• Product Code: LXH
• UDI-Device Identifier: 08033390024730
• UDI-Public: 08033390024730
• Combination Product (Y/N): N
• 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): 05/12/2026

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: 9043.10.310
• Device Catalogue Number: 9043.10.310
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/14/2026
• 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