MAUDE Adverse Event Report: LIMACORPORATE SPA BONE SCREW Ø6,5 H.30MM; BONE SCREW Ø6,5 H.30MM (LPH, MBL, LZO, PHX, MBF)

Model Number 8420.15.030

Device Problem Device Slipped (1584)

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

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

Based on the first investigation, from the check of the manufacturing charts of the acetabular cup no dimensional anomalies were found on a total of (b)(4) delta pf cups manufactured with the same lot# (1813072, ster.1800292).Moreover, (b)(4) out of (b)(4) cups with the same lot# were already implanted without receiving additional/similar complaints.From the check of the manufacturing charts of the bone screw, no dimensional anomalies found on a total of (b)(4) screws manufactured with the same lot# (1807675, ster.1800172).Moreover, (b)(4) out of (b)(4) pieces with the same lot# were already implanted without receiving additional/similar complaints.We will proceed with further investigations and submit a final mdr once concluded.

Event Description

During total hip replacement surgery performed on (b)(6) 2019, a screw (code #8420.15.030, lot #1807675) passed through the hole of the delta pf acetabular cup (code #5551.25.521 lot #1813072).From reported info, it was unknown what had caused the event.Surgeon decided to keep the screw implanted.

• Brand Name: BONE SCREW Ø6,5 H.30MM
• Type of Device: BONE SCREW Ø6,5 H.30MM (LPH, MBL, LZO, PHX, MBF)
• 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: 8398347
• MDR Text Key: 138095047
• Report Number: 3008021110-2019-00018
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K172456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8420.15.030
• Device Lot Number: 1807675
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1