MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA DUAL MOBILITY SYSTEM; LINER #L FOR MOBILE LINER DIA. 42 MM

Model Number	5885.09.042
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
By checking the dhrs of the involved lot numbers no pre-existing anomalies were detected.A final report will be submitted at the end of investigations.This is the first complaint received on the lot numbers involved.
Event or Problem Description
During hip surgery performed on (b)(6) 2025, an issue was observed intraoperatively with the liner #l for mobile liner ø42 (product code: 5885.09.042, batch n° 2430719, sterilization n° 2400269).Despite being correctly positioned, the insert was mobilizing.Additionally, the component, although initially appearing stable, would disassemble from the cup when maneuvers were performed.Due to these issues, it was necessary to use another polyethylene insert.Patient: male.Event occurred in italy.
Event or Problem Description
During hip surgery performed on (b)(6) 2025, an issue was observed intraoperatively with the liner #l for mobile liner ø42 (product code: 5885.09.042, batch n° 2430719, sterilization n° 2400269) despite being correctly positioned, the insert was mobilizing.Additionally, the component, although initially appearing stable, would disassemble from the cup when maneuvers were performed.Due to these issues, it was necessary to use another polyethylene insert.Patient: male event occurred in italy.
Additional Manufacturer Narrative
By checking the dhrs of the involved lot numbers no pre-existing anomalies were detected on the (b)(4) manufactured with batch n° 2430719.According to our data at least 12 out of 18 pieces manufactured with batch n°2430719 - sterilization n° 2400269 were implanted and this is the first complaint received on the lot numbers involved.The device involved was returned to limacorporate for further investigation.From a dimensional check no anomalies were highlighted, the piece resulted in conformity with the specification requirements on the drawing.After the dimensional check, a functional test was performed, and the cup correctly assembled with the reported liner (product code: 5885.09.042, batch no: 2430719, sterilization no: 2400269).The exact root cause of the event could not be determined.However, it is presumed that the most likely cause was the presence of foreign material between the two components during the surgical procedure, which may have prevented proper assembly.Conclusion the device history records (dhrs) related to the involved lot number did not reveal any pre-existing anomalies.Dimensional inspections confirmed compliance with the applicable drawing specifications.During functional testing, the liner assembled correctly with the cup.Based on the above findings, we conclude that the event is not product-related.The most probable root cause appears to be the presence of foreign material between the two components during the surgical procedure.Pms data : according to limacorporate pms data the occurrence rate of similar events - intraoperative issues on assembling cup with liner for mobile liners (family code: 5885.09.040-042) - is nearly (b)(4).Based on the investigation performed, no corrective actions are required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr report.

• Brand Name: DELTA DUAL MOBILITY SYSTEM
• Common Device Name: LINER #L FOR MOBILE LINER DIA. 42 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 32; san daniele del friuli - udine, 33038
• MDR Report Key: 21459560
• Report Number: 3008021110-2025-00012
• Device Sequence Number: 7591486
• Product Code: LZO
• UDI-Device Identifier: 08033390020060
• UDI-Public: 08033390020060
• Combination Product (Y/N): N
• PMA/510(K) Number: K181491
• 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,Followup
• Report Date (Section B): 07/31/2025

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: 5885.09.042
• Device Catalogue Number: 5885.09.042
• Device Lot Number: 2430719
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 08/19/2025
• 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: Other
• Patient Sex: Unknown