MAUDE Adverse Event Report: LIMACORPORATE S.P.A.; LINER FOR METAL-BACK (UHMWPE) LINER STANDARD

Catalog Number 1377.50.010

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

No pre-existing anomaly was detected by the check of the device history records of the lot numbers involved (1905063, 20at168).This is the first and only complaint received on these lot numbers.A final report will be submitted after the investigation.

Event Description

Intra-operative issue occurred during shoulder surgery: when the surgeon tried to implant the liner (code 1377.50.010, lot 20at168) into the metal back glenoid (code 1375.20.010, lot 1905063), it was unstable.The same issue occurred with a second available liner (belonging to the same code and lot of the first one).Eventually, the metal back and liner were replaced with a different size and the surgery was positively completed with about 40 minutes of delay.This event occurred in italy.

• Type of Device: LINER FOR METAL-BACK (UHMWPE) LINER STANDARD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 17806300
• MDR Text Key: 324113890
• Report Number: 3008021110-2023-00109
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K113254
• 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 Catalogue Number: 1377.50.010
• Device Lot Number: 20AT168
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2023
• 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