MAUDE Adverse Event Report: LIMACORPORATE SPA SMR CEMENTLESS FINNED STEM; SMR CEMENTLESS FINNED STEM (HSD-KWT)

Model Number 1304.15.230

Device Problem Defective Component (2292)

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

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing and sterilization charts of the lot #1709172, ster.1700246 no anomaly was found.This is the first and only complaint received on this lot#.We will submit a final report once the incident investigation will be concluded.

Event Description

Intra-operative issue performed on (b)(6) 2019.During smr reverse surgery, the pouches of the humeral stem code 1304.15.230 lot #1709172, ster.1700246 were found to be damaged, with potential loss of sterility.According to the info reported, the plan was to implant a 23 stem with a s liner.Since another stem of the same size was not available in theatre, the surgeon made a reposition with the trials using a 22 stem and l liner.The event prolonged the surgery of approximately 7 minutes.Event occurred in (b)(6).

Event Description

Intra-operative issue experienced on october 1st, 2019.During smr reverse surgery, the pouches of the humeral stem code 1304.15.230 lot #1709172, ster.1700246 were found to be damaged, with potential loss of sterility.According to the info reported, the plan was to implant a 23mm stem with a s size liner.Since another smr humeral stem of the same size was not available in theatre, the surgeon decided to implant a 22mm stem and l size liner.The event prolonged the surgery of approximately 7 minutes.Event happened in germany.

Manufacturer Narrative

By checking the manufacturing charts of the lot# 1709172 involved, no pre-existing anomaly was found on a total of 34 humeral stems manufactured with the same lot#.Moreover, at least 21 out of 34 humeral stems with the same lot# have already been implanted without receiving additional complaints on them.The humeral stem (and its packaging) involved in the complaint was not received by limacorporate for further analysis.By the pictures received, we could confirm the issue reported.We had the possibility to check 3 pieces with the same lot# available in a lima subsidiary warehouse: all the 3 pieces were ok, with no pouches damaged.Furthermore, by checking the packaging status of some pieces belonging to the same family codes (different lots), no similar problems affecting the packaging were found.Based on the analysis performed, we can conclude that the reported packaging issue was a single item issue, limited to this single piece, as confirmed by the absence of similar problems on the other stems we could check (same lot# and same family with different lot#s).A possible contributory factor to this damage could be related to innacurate handling during transport/movements of the device.In 2012 limacorporate introduced an additional pouch that physically separates the stem from the internal vacuumed pouch.This additional pouch is not vacuumed and it is in direct contact with the component to protect the external vacuumed pouches.The stems are therefore packaged in two vacuumed pouches + one internal not vacuumed pa pouch.As a further improvement, a new type of external box was introduced in 2016, the new box contains protective sponges and further reduces the risk of damages to the packaging.Pms data: according to our pms data, the global occurence rate of this kind of packaging issues is (b)(4) (occurence rate estimated as the number of similar complaints received on smr cementless stems with codes 1304.15.Xxx, on the total number of stems with codes 1304.15.Xxx sold ww since 2002).This is the first and only similar intra-operative complaint received on smr cementless stems involving the last packaging version (internal pa pouch + 2 vacuumed pouches + improved box with protective sponges), thus the occurence rate for smr cementless stems with the last version of packaging is (b)(4).No specific action for this case.Limacorporate will continue monitoring the market to promptly detect any further similar event.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: SMR CEMENTLESS FINNED STEM (HSD-KWT)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9196449
• MDR Text Key: 199911622
• Report Number: 3008021110-2019-00119
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K101263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1304.15.230
• Device Lot Number: 1709172
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization