MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA LINERS & ACCESSORIES; NEUTRAL LIMAVIT LINER I.D. 36MM, SIZE MEDIUM+

Model Number	5885.54.259
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to dislocation.The following components were removed: - delta tt pro d.52mm medium+ (part code 5553.14.523, lot number 2333067, sterilization (b)(4)).- delta neutr.Liner d.36mm #m+ (part code 5885.54.259, lot number 24at0a7, sterilization (b)(4)).- bone screw ø6,5 h.30mm (part code 8420.15.030, lot number 2509960, sterilization (b)(4)).These components were replaced by the following new ones: - delta tt cup d.54mm (part code 5552.15.540, lot number 2304688, sterilization (b)(4)).- delta mobile liner (part code 5566.50.420, lot number 20at0y8, sterilization (b)(4)).- bone screw dia=6.5mm h=25mm (part code 8420.15.020, lot number 2411118, sterilization (b)(4)).- bone screw dia=6.5mm h=35mm (part code 8420.15.040, lot number 2201892, sterilization (b)(4)).- delta cup dual mobility liner #large (part code 5885.09.042, lot number 2017046, sterilization (b)(4)).Previous surgery was performed on (b)(6) 2025.The patient is a male, date of birth (b)(6)1953.The event happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lot number, no pre-existing anomaly was discovered in the items belonging to the following lot numbers: - lot number 2333067, sterilization (b)(4).- lot number 24at0a7, sterilization (b)(4).- lot number 2509960, sterilization (b)(4).The manufacturer will submit a final mdr as soon as the investigation is complete.

• Brand Name: DELTA LINERS & ACCESSORIES
• Common Device Name: NEUTRAL LIMAVIT LINER I.D. 36MM, SIZE MEDIUM+
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 22922803
• Report Number: 3008021110-2025-00110
• Device Sequence Number: 21121251
• Product Code: LPH
• UDI-Device Identifier: 08033390136105
• UDI-Public: 08033390136105
• Combination Product (Y/N): N
• PMA/510(K) Number: K182099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 08/29/2025

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: 5885.54.259
• Device Lot Number: 24AT0A7
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown