MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DIA. 14 - TRIAL STEM WITH QUICK CONNECTION

Model Number 9013.02.141

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

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

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

We will send a final mdr once the investigation will be concluded.

Event Description

Smr trial stem pin welding defect noticed on (b)(6) 2017.According to the information reported, the trial stem d.14mm metal tips were protruding outwards leading to a failure in coupling the trial stem with the conical reamer guide.Prolonged surgery time sue to this issue: less than 5 minutes.Number of uses of the trial stem is unknown.Event happened in (b)(6).

Event Description

Smr trial stem pin welding defect noticed during a surgery on (b)(6) 2017.One of the two pins of the trial stem dia.14mm was protruding outwards leading to difficulty in coupling the trial stem with the conical reamer guide.Prolonged surgery time sue to this issue: less than 5 minutes.Surgery concluded successfully.Number of uses of the trial stem is unknown.Event happened in australia.

Manufacturer Narrative

No anomalies on the 50 trial stems released on the market with lot#: 14aa461 were found by checking the related manufacturing chart.This is the only intra-op issue reported on this specific lot#.We received the trial stem involved and confirmed that the cause for the intra-op issue reported is the partial shifting of one of the 2 pins which are welded on the male taper of the trial stem; the male taper of the trial stem is to be connected to the guide for the conical reamer.The partial shifting of one pin (due to welding failure of the pin) caused the impossibility to properly connect the trial stem to the guide for conical reamer.Pms data: a total of 12 similar intra-op issues were reported on smr trial stems with model#: 9013.02.141÷241, on a total of over (b)(4) usages of trial stems with these model#: since 2014.This gives an occurrence rate of (b)(4).As an improvement, lima corporate introduced on the market a new design of smr trial stems, with new coupling mechanism between the trial stems and the guide for conical reamer.In the new design, the pins are no more present on the trial stem, therefore there is no possibility that a similar issue occurs with the new design of trial stems.Lima corporate will keep monitored the market to confirm the effectiveness of the design improvement.

• Brand Name: DIA. 14 - TRIAL STEM WITH QUICK CONNECTION
• Type of Device: DIA. 14 - TRIAL STEM WITH QUICK CONNECTION
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 7081974
• MDR Text Key: 94978691
• Report Number: 3008021110-2017-00108
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.02.141
• Device Lot Number: 14AA461
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization