MAUDE Adverse Event Report: LIMACORPORATE S.P.A DELTA TT; ACETABULAR CUPS (TI6AL4V) DIA. 58MM FOR LINER SIZE LARGE CLOSE

Model Number	5552.15.580
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
A hip revision surgery was performed on (b)(6) 2026 due to implant loosening.The surgeon removed the delta tt cup, liner, and screws.X-rays showed radiographic lines around the cup; therefore, the surgeon expected the implant to come out easily.However, removal with the explant tool took some time, and the surgeon noted an impressive amount of good bone in-growth/on-growth.Previous surgery was performed on (b)(6) 2023.The surgeon followed the standard surgical workflow for hip revision.The explanted components included: delta-tt acetab.Cup ø58 mm for (product code 5552.15.580, lot 2202753, ster.N.(b)(4).Patient is male.Event happened in new zealand.
Additional Manufacturer Narrative
Investigation the explanted component has been discarded and cannot be returned to the manufacturer for identification and analysis.Checking the manufacturing charts of the involved lot #2202753, no pre-existing anomalies were found on the components manufactured with the same lot # and sterilization number.A final mdr will be shared upon completion of the investigation.

• Brand Name: DELTA TT
• Common Device Name: ACETABULAR CUPS (TI6AL4V) DIA. 58MM FOR LINER SIZE LARGE CLOSE
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25715658
• Report Number: 3008021110-2026-00285
• Device Sequence Number: 5108486
• Product Code: LPH
• UDI-Device Identifier: 08033390040655
• UDI-Public: 08033390040655
• Combination Product (Y/N): Y
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5552.15.580
• Device Catalogue Number: 5552.15.580
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown