MAUDE Adverse Event Report: LIMACORPORATE S.P.A. BEATER - POSITIONER - ALIGNER; IMPACTOR - POSITIONER - ALIGNER

Model Number 9057.20.555

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

By the check of the dhr, no pre-existing anomaly was detected on the 20 instruments manufactured with lot #20ar0ag.This is the first and only complaint received on this lot# (20ar0ag).We will send a final mdr once the investigation will be concluded.

Event Description

During surgery performed on (b)(6) 2021, while implanting the definitive delta tt acetabular cup.The tip of the beater positioner aligner (product code 9057.20.555, lot #20ar0ag) extruded from the delta tt cup's surface.The cup was correctly threaded to the instrument.According to the complaint source, the instrument was used less than 10 times.Surgery was prolonged of about 30 minutes.Event occurred in (b)(6).

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #20ar0ag, no pre-existing anomaly was found on a total of 20 items manufactured with the same lot #.This is the only complaint received on this lot #.Additionally, checking the manufacturing charts of the involved delta tt cup with lot #2021581, no pre-existing anomaly was found on a total of 60 items manufactured with the same lot #.Items analysis the items involved were not available to be returned to limacorporate for further analysis.According to the surgical technique, following the acetabular reaming procedure, the trial cup is threaded onto the beater-positioner-aligner (product code 9057.20.555) or onto the multi-purpose handle (product code (9055.28.400) for visualization and assessment of fit, contact, congruency and orientation within the acetabulum.Then, the definitive cup with the same nominal diameter of the final trial cup used is impacted in the acetabulum.The definitive implant is placed onto the cup adaptor (size depends on cup's size) and to the wrench for delta cups (product code 9055.51.015).The definitive cup is so impacted.However, according to the received information, the reported issue was experienced during the surgery when the beater-positioner-aligner was used to impact the definitive acetabular cup (belonging to lot #2021581), therefore the instrument had been used off-label.Therefore, the reported issue refers to an off-label use of the instrument.Indeed, no extrusion of the tip of the beater - positioner - aligner (product code 9057.20.555) is observed when trial acetabular cups are threaded on it.Considering that: · check of the manufacturing charts highlighted no anomalies on the components manufactured with lot #20ar0ag; · the surgical technique states that the use of the beater - positioner - aligner (product code 9057.20.555) is intended with trial cups only, and that definitive acetabular cups should be implanted using its suitable instrument; we can state that the event was due to an off-label use of the instrument.Pms data.According to our pms data, we can estimate the occurrence rate of the malfunction of the instrument 9057.20.555 to be (b)(4) % (ww).Please note that this occurrence rate is overestimated because it does not consider the reuse of the instruments but only the total number of pieces manufactured.Limacorporate continues monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

During a hip surgery performed on (b)(6) 2021, while implanting the delta-tt acetabular cup ø50 mm (product code 5552.15.500, lot #2021581 - ster.2000401), the tip of the beater - positioner - aligner (product code 9057.20.555, lot #20ar0ag) extruded from the surface of the cup, eventually affecting the final implant fixation/stability.It was reported that the surgeon accepted the cup stability at last.According to the reported information, the cup was correctly threaded to the instrument.The complaint source reported that the instrument was used less than 10 times.Surgery was prolonged of about 30 minutes.Event occurred in south korea.

• Brand Name: BEATER - POSITIONER - ALIGNER
• Type of Device: IMPACTOR - POSITIONER - ALIGNER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11357250
• MDR Text Key: 241755102
• Report Number: 3008021110-2021-00008
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K112158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

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: 9057.20.555
• Device Lot Number: 20AR0AG
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization