MAUDE Adverse Event Report: LIMACORPORATE SPA LINER HIGH WALL MEDIUM+ Ø36MM; LINER HIGH WALL MEDIUM+ Ø36MM (LPH, MBL)

Model Number 5887.54.259

Device Problem Positioning Problem (3009)

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

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing chart of the involved lot# no pre - existing anomaly was found.We will submit a final mdr once the investigation will be concluded.

Event Description

During surgery occurred on (b)(6) 2019 the delta pro liner (liner high wall medium+ ø36mm, code # 5887.54.259, lot # 1901920) did not engage the delta tt pro acetabular cup.At the end, a new delta pro liner was used and surgery was concluded without additional issues.

• Brand Name: LINER HIGH WALL MEDIUM+ Ø36MM
• Type of Device: LINER HIGH WALL MEDIUM+ Ø36MM (LPH, MBL)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: federica malvaso ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8733519
• MDR Text Key: 149795038
• Report Number: 3008021110-2019-00072
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K182099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/25/2019

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: No Information
• Device Model Number: 5887.54.259
• Device Catalogue Number: 5887.54.259
• Device Lot Number: 1901920
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1