MAUDE Adverse Event Report: LIMACORPORATE SPA SMR - TRIAL STEM D.16 MM

Model Number 9013.02.161

Device Problem Positioning Failure (1158)

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

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

No anomaly emerged from the check of the dhr of the lot involved (trial stem: lot #2014aa473; std reverse humeral body: lot #2014aa176; short reverse humeral body: lot #2015aa015), thus indicating that the pieces released on the market were compliant to specifications.We will submit a final emdr when the investigation will be completed.

Event Description

During shoulder arthroplasty performed on (b)(6) 2016, the scrub nurse was setting up the trial stem (model #9013.02.161; lot #2014aa473) with the trial humeral reverse body and it was noticed that the instruments would not engage together.Both the standard (model #9013.52.021; lot #2014aa176) and short (model #9013.52.011; lot #2015aa015) trial humeral reverse bodies had the same problem with the trial stem.This issue did not affect the surgery since the trial stem could be properly engaged with the stem impactor.No reported consequences for the patient and no prolonged surgery time.Event happened in (b)(6).

Manufacturer Narrative

Check of the dhr: no anomaly emerged from the check of the dhr of the lot involved (trial stem: lot #14aa473; std reverse humeral body: lot #14aa176; short reverse humeral body: lot #15aa015), thus indicating that the pieces released on the market were up to specifications.The instruments were not returned to lima corporate for analysis; therefore it was not possible to investigate the root cause of the event.Internal analysis based on items returned from the market and affected by the same issue, revealed that root cause of the event is mostly related the manufacturing process of a specific lima corporate supplier.The involved supplier does not produce smr trial stems for limacorporate anymore.As an improvement, limacorporate 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.No smr trial stem with the new design have been produced by the involved supplier.Limacorporate is aware of 21 intra-operative similar issue on smr trial stem product code 9013.02.(b)(4) items manufactured.All the complaints involved trial stems with the old design.None of these complaints led to serious consequences on the patients.Limacorporate will keep monitored the market to confirm the effectiveness of the design improvement.

Event Description

During a shoulder arthroplasty performed on (b)(6) 2016, the scrub nurse was setting up the trial stem (product code #9013.02.161; lot #14aa473) with the trial humeral reverse body and it was noticed that the instruments did not engage together.Both the standard (product code #9013.52.021; lot #14aa176) and short (product code #9013.52.011; lot #15aa015) trial humeral reverse bodies had the same problem with the trial stem.This issue did not affect the surgery since the trial stem could be properly engaged with the stem impactor.No reported consequences for the patient and no prolonged surgery time.Event happened in new zealand.

• Brand Name: SMR - TRIAL STEM D.16 MM
• Type of Device: SMR - TRIAL STEM D.16 MM
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 6770376
• MDR Text Key: 82147732
• Report Number: 3008021110-2016-00129
• 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
• Report Date: 10/12/2020

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: Health Professional
• Device Model Number: 9013.02.161
• Device Lot Number: 14AA473
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2016
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 12/29/2016
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization