MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA PROTR.LINER ØINT 36MM #L; PROTRUDED LINER (UHMWPE X-LIMA + TI6AL4V) I.D. 36MM - SIZE LARGE

Model Number 5886.51.260

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

By the check of the dhrs, no pre-existing anomaly was found on the 55 liners placed on the market with the same lot number (1920249).No other complaint received on this lot.We will submit a final mdr as soon as the investigation will be completed.

Event Description

During the surgery performed on (b)(6) 2019, soon after the impaction of the liner (code 5886.51.260, lot 1920249), the surgeon noted that it was unstable inside the acetabular cup.He then removed the liner from the cup and noticed that the titanium cap had moved from its correct position on the top of the liner peg.The cap was promptly recovered by the surgeon, who implanted another available liner without any further issue.The problem did not cause prolonged surgical time, nor other consequences for the patient.Event happened in (b)(6).

• Brand Name: DELTA PROTR.LINER ØINT 36MM #L
• Type of Device: PROTRUDED LINER (UHMWPE X-LIMA + TI6AL4V) I.D. 36MM - SIZE LARGE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 9544811
• MDR Text Key: 220796479
• Report Number: 3008021110-2019-00150
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K112898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5886.51.260
• Device Lot Number: 1920249
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability