MAUDE Adverse Event Report: LIMACORPORATE S.P.A. MOBILE LINER DIA.INT.28MM DIA.EXT.40MM

Model Number 5566.50.401

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 06/16/2023

Event Type  Injury  

Event Description

Hip revision surgery due to disassembly between the mobile liner and the humeral head.Based on the available information, the mobile liner is a lima device (code 5566.50.401, lot 21at0sv, ster.2100238), while the head is from a different manufacturer.It was reported that the same issue had already occurred for the same patient, but no further information is available at the moment.The previous surgery took place on (b)(6) 2018, the revision surgery on (b)(6) 2023.Patient is female, 77 years old.This event occurred in uk.

Manufacturer Narrative

No pre-existing anomalies were detected by the check of the device history records of the lot number involved (21at0sv ster.2100238).A final report will be submitted after the conclusion of the investigation.

• Brand Name: MOBILE LINER DIA.INT.28MM DIA.EXT.40MM
• Type of Device: MOBILE LINER DIA.INT.28MM DIA.EXT.40MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 17286019
• MDR Text Key: 318649734
• Report Number: 3008021110-2023-00081
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K181491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5566.50.401
• Device Catalogue Number: 5566.50.401
• Device Lot Number: 21AT0SV
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention