MAUDE Adverse Event Report: LIMACORPORATE S.P.A ACETABULAR INSTRUMENT SET; BEATER-POSITIONER-ALIGNER,

Model Number	9057.20.555
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation checking the manufacturing charts of the involved lot #17ap040, no pre-existing anomaly was found on the 33 devices manufactured with the same lot #.This is the first and only complaint received on this lot #.Based on a preliminary evaluation of the description and according to the surgical technique, we would like to highlight that the correct instrument for implanting the definitive cup is the wrench for delta cup (code 9055.51.015).The use of the beater - positioner - aligner (code 9057.20.555) for implanting definitive acetabular cups is considered off-label, as it is specifically intended for positioning trial cups.We submit a final mdr when the devices are returned and the investigation will be completed.
Event or Problem Description
During the hip surgery performed on (b)(6) 2025, the surgeon impacted delta tt cup 54 mm (5522.15.540, lot#2502334) with beater - positioner - aligner, which was attached to the cup, but it was impossible to removed it from the cup.Again, the cup was inserted, and it was unstable.Therefore, he reamed for a cup (56mm) and the cup was implanted.Due to the event, the surgery was prolonged for 20 minutes.Below is the suspected product: beater - positioner - aligner (9057.20.555, lot#17ap040) - product sold in us.Event happened in japan.

• Brand Name: ACETABULAR INSTRUMENT SET
• Common Device Name: BEATER-POSITIONER-ALIGNER,
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038

via nazionale 52

villanova di san daniele, udine 33038

• MDR Report Key: 22686801
• Report Number: 3008021110-2025-00104
• Device Sequence Number: 9447672
• Product Code: LPH
• UDI-Device Identifier: 08033390025744
• UDI-Public: 08033390025744
• Combination Product (Y/N): N
• PMA/510(K) Number: K112158
• 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,Followup
• Report Date (Section B): 08/01/2025

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: 9057.20.555
• Device Catalogue Number: 9057.20.555
• Device Lot Number: 17AP040
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown