MAUDE Adverse Event Report: LIMACORPORATE S.P.A. MOBILE LINER ØINT 28 MM Ø42 MM; MOBILE LINER DIA.INT.28MM DIA.EXT.42MM

Model Number 5566.50.420

Device Problems Break (1069); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

Intra-operative issue occurred during hip surgery performed on the (b)(6) 2021.According to the information received, the mobile liner øint 28 mm ø42 mm (product code 5566.50.420 lot 20at5lh, ster.2100192) was damaged in the attempt to disassemble it from the head (fem.Modular head - m ø28mm, product code 5010.09.282, lot 1801390, ster.1800070).The liner-head construct had in fact been assembled incorrectly during the surgery.The consequence was a prolongation of the surgical time of approximately 45/60 minutes.Eventually it was decided to implant a 40mm mobile liner (product code 5566.50.401, lot 21at0sv, ster.2100243) and a ceramic head (product code 5010.42.282, lot 1780517, ster.1700135), with a spacer (product code 5885.15.510, lot 1511476, ster.2100161 - product not marketed in the us).In addition, it was reported that the metal liner for dual mobility was mistakenly not implanted and therefore the patient had to be revised few days later.The revision surgery was registered as medical complaint n.(b)(4) and reported to the fda by mfr #3008021110-2021-00104.Event occurred in (b)(6).

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the involved lot numbers: no pre-existing anomaly on the 60 mobile liners released with lot number 20at5lh, ster.2100192.No pre-existing anomaly on the 50 heads released with lot number 1801390, ster.1800070 thus we can state they have been manufactured up to specifications.This is the first and only complaint received on these lot numbers.A final mdr will be submitted after the conclusion of the investigation.

• Brand Name: MOBILE LINER ØINT 28 MM Ø42 MM
• Type of Device: MOBILE LINER DIA.INT.28MM DIA.EXT.42MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 13107553
• MDR Text Key: 289600304
• Report Number: 3008021110-2021-00108
• 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

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: 5566.50.420
• Device Catalogue Number: 5566.50.420
• Device Lot Number: 20AT5LH
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2021
• 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): Hospitalization