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

Model Number	BEATER-POSITIONER-ALIGNER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The check of dhrs of the involved lot number: 20ar0g1 did not highlight any pre-existing anomalies on the pieces manufactured with this lot number.This is the first complaint on this lot number.A final report will be submitted after the investigation.
Event or Problem Description
The complaint source reported an intra-operative issue, since it was not possible to disconnect beater - positioner - aligner (product code: 9057.20.555, lot: 20ar0g1) from delta-tt acetab.Cup ø50 mm ((product code: 5552.15.500, lot: 2538423 - ster: (b)(6)) after impaction.As there was sufficient bone stock, the socket could be reamed to the next acetabular cup size 52 mm and seated using the alternative setting instrument wrench for cups (product code:9055.51.015).No prolonged surgery was reported.The instrument was checked prior to use.The instrument was used approximately 50 to 100 times.Event occurred in austria.

• 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
• MDR Report Key: 25238763
• Report Number: 3008021110-2026-00233
• Device Sequence Number: 13192925
• Product Code: KWZ
• UDI-Device Identifier: 08033390025744
• UDI-Public: 08033390025744
• Combination Product (Y/N): N
• PMA/510(K) Number: FDA PREMARKE
• 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): 05/19/2026

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: BEATER-POSITIONER-ALIGNER
• Device Catalogue Number: 9057.20.555
• Device Lot Number: 20AR0G1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/21/2026
• 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