MAUDE Adverse Event Report: LIMACORPORATE S.P.A DELTA CUP ACCESSORIES; NEUTRAL LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 32MM - SIZE LARGE

Model Number	5885.51.160
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
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 #2114151, no pre-existing anomalies were found on the components manufactured with the same lot # and sterilization number.This is the first complaint received for the involved lot # and sterilization number.A final mdr will be shared upon completion of the investigation.
Event or Problem Description
A hip revision surgery was performed on (b)(6) 2026.The surgeon observed dislocation and luxation, therefore removed the liner and replaced it with a dual mobility liner.The patient was experiencing pain and loss of motion one year after the thjr surgery.Previous surgery was performed on (b)(6) 2025.The surgeon followed the standard surgical workflow for hip revision.The explanted components included: delta neutr.Liner øint 32mm #l (product code 5885.51.160, lot 2114151, ster.N.(b)(6)).Patient is female, 1.66 m tall and weighs 78 kg.Event happened in new zealand.

• Brand Name: DELTA CUP ACCESSORIES
• Common Device Name: NEUTRAL LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 32MM - SIZE LARGE
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25715657
• Report Number: 3008021110-2026-00284
• Device Sequence Number: 12039250
• Product Code: LPH
• UDI-Device Identifier: 08033390041089
• UDI-Public: 08033390041089
• 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

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: 5885.51.160
• Device Catalogue Number: 5885.51.160
• 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