MAUDE Adverse Event Report: LIMACORPORATE SPA SMR GLENOID PEG TT SMALL-R #XL; SMR GLENOID PEG TT SMALL-R #XL (KWS-KWT)

Model Number 1375.14.654

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Staphylococcus Aureus (2058)

Event Type  Injury  

Manufacturer Narrative

Check of the dhrs: by checking the sterilization charts of the components involved, no anomaly was found: on a total of (b)(4) smr connector small r manufactured with lot # 1606802, ster.1600152.On a total of (b)(4) smr glenoid peg tt small-r # xl manufactured with lot # 1409286, ster.1400245.On a total of (b)(4) bone screw ø6,5 h.35 mm manufactured with lot # 1511994, ster.1500317.On a total of (b)(4) bone screw ø6,5 h.35 mm manufactured with lot # 1519625, ster.1600018.Therefore, we can state that all the components have been properly sterilized before being placed on the market.Stating that: no additional info related to patient conditions; no x-ray images except a single post op image referring to first stage revision surgery showing all the components were explanted; no explanted component were provided by the complaint source to the manufacturer, there is no possibility at this stage to perform a deeper investigation.No certain root cause can be estimated for this case but, based on the check of the sterilization charts performed we can speculate infection was not product related.Should we receive additional info in the future, we will provide an updated final incident report about this case.Pms data: according to our pms data, revision rate of smr reverse system due to infection is (b)(4).None of the cases we could investigate were classified as product related.No corrective actions planned for this case.Lima corporate will keep monitored the market.Please, consider this mdr as a combined initial-final report.

Event Description

First stage revision surgery of a smr reverse performed in (b)(6) 2018 due to infection.Primary surgery was performed on the (b)(6) 2016.According to the info reported, bacterium responsible for infection was staphylococcus epidermidis.During the revision surgery, the following components were explanted: smr reverse humeral body short (not marked in usa), smr rev.Hp lat.Liner medium (not marked in usa), smr connector small r, code 1374.15.305, lot # 1606802, ster.1600152, smr rev.Hp correct.Glenosph.(not marked in usa), smr glenoid peg tt small-r # xl, code 1375.14.654, lot #1409286, ster.1400245, smr glenoid baseplate small-r (not marked in usa), bone screw ø6,5 h.35 mm, code 8420.15.040, lot # 1511994, ster.1500317, bone screw ø6,5 h.35 mm, code 8420.15.040, lot # 1519625, ster.1600018.According to the info reported, patient will receive a custom made implant during the second stage revision planned for (b)(6) 2019.No additional info received by the complaint source.Event occurred in (b)(6).

• Brand Name: SMR GLENOID PEG TT SMALL-R #XL
• Type of Device: SMR GLENOID PEG TT SMALL-R #XL (KWS-KWT)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, 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: 9129558
• MDR Text Key: 166398092
• Report Number: 3008021110-2019-00109
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K133349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1375.14.654
• Device Lot Number: 1409286
• Date Manufacturer Received: 09/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention