MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA PF CUP; WRENCH

Model Number	9055.51.015
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No pre-existing anomalies were detected by the check of the device history records of the lot number involved.This is the first and only complaint recorded on this lot n.A final report will be submitted after the investigation.
Event or Problem Description
Intra-operative issue occurred during hip surgery on (b)(6) 2026: two of the magnets of the delta cup - wrench (product code 9055.51.015, lot 25ar079) came loose when the delta cup was driven into the acetabulum.The complaint source reported that the delta cup was still able to be implanted and the surgeon was satisfied with the surgical outcome.This event occurred in germany.

• Brand Name: DELTA PF CUP
• Common Device Name: WRENCH
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25469771
• Report Number: 3008021110-2026-00251
• Device Sequence Number: 18730117
• Product Code: MBL
• UDI-Device Identifier: 08033390025409
• UDI-Public: 8033390025409
• 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): 06/11/2026

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: 9055.51.015
• Device Lot Number: 25AR079
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown