MAUDE Adverse Event Report: LIMACORPORATE SPA FEM. MODULAR HEAD - M Ø36MM; FEM. MODULAR HEAD - M Ø36MM (LZO JDI KWY KWZ LPH MBL)

Model Number 5010.42.362

Device Problems Physical Resistance/Sticking (4012); Device Fell (4014)

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

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # involved (#1881436) did not show any anomaly on the products manufactured with this lot #.We will submit a final report once the investigation will be completed.

Event Description

During surgery performed on (b)(6) 2019, while the surgeon was impacting the ceramic head (code #5010.42.362, lot #1881436) to a stem, the head's plastic cover got stuck.When the head was removed to remove the stuck plastic, a tip of the cover fell into surgical field.The surgery was prolonged for 15 minutes due to the event.There were no consequences on the patient.Event occurred in (b)(6).

• Brand Name: FEM. MODULAR HEAD - M Ø36MM
• Type of Device: FEM. MODULAR HEAD - M Ø36MM (LZO JDI KWY KWZ LPH MBL)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA
• Manufacturer Contact: federica malvaso ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8415847
• MDR Text Key: 139211197
• Report Number: 3008021110-2019-00021
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K141327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 03/13/2019

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: 5010.42.362
• Device Lot Number: 1881436
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization