MAUDE Adverse Event Report: LIMACORPORATE S.P.A ECCENTRICAL GLENOSPHERE DIA. 40 MM

Model Number 1376.09.041

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

Investigation by checking the sterilization charts of the involved lots, no pre-existing anomaly was found on the overall number.Therefore, we can ensure that all the products placed on the market with these lots have been properly sterilized before being placed on the market.We will send a final mdr once the investigation will be completed.

Event Description

Revision surgery of prima humeral system performed on (b)(6) 2022 due to infection.Explanted components: · prima stem #4, product code: 1357.14.034, lot: 2200584, ster.2200054.· prima rev.Insert #short d.40mm, product code: 1367.15.010, lot: 2200832, ster.2200062.· prima rev.Insert #short d.40mm, product code: 1367.54.200, lot: 2124968, ster.2200071.· smr connector small r, product code: 1374.15.305, lot: 2208437, ster.2200119.· smr glenoid peg tt small-r #m, product code: 1375.14.652, lot: 2204905, ster.2200097.· smr eccent.Glenosphere ø 40mm, product code: 1376.09.041, lot: 2203272, ster.2200079.According to the information received, patient presented with infection, caused by c-acne, on date unknown.Prima implants originally implanted on (b)(6) 2022 were removed and so was smr eccent.Glenosphere ø 40mm.Event happened in us.

Manufacturer Narrative

By checking the sterilization charts of the involved lots, no pre-existing anomaly was found on the overall number.Therefore, we can ensure that all the products placed on the market with these lots have been properly sterilized before being placed on the market.The items involved were not available to be returned to limacorporate for further analysis.Further information was requested to the complaint source but none was available.Based on the very few information received, we are not able to further investigate the root cause of the event.In conclusion: - the check of the dhr highlights no pre-existing anomalies on the components involved; - according to the information received, patient presented with infection, caused by c-acne.For these reasons, we can state that the event was not product related.Pms data.According to limacorporate pms data, revision rate of smr reverse prosthesis due to infection is 0.078% for prima stem #4, product code 1357.14.Xxx prothesis this is the first complaint for infection involving this component marketed from 2022.No specific corrective action is needed for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issues.

Event Description

Revision surgery of prima humeral system performed on 06 october 2022 due to infection.Explanted components: · prima stem #4, product code 1357.14.034, lot 2200584, ster.2200054; · prima rev.Insert #short d.40mm, product code 1367.15.010, lot 2200832, ster.2200062; · prima rev.Insert #short d.40mm, product code 1367.54.200, lot 2124968, ster.2200071; · smr connector small r, product code 1374.15.305, lot 2208437, ster.2200119; · smr glenoid peg tt small-r #m, product code 1375.14.652, lot 2204905, ster.2200097; · smr eccent.Glenosphere ø 40mm, product code 1376.09.041, lot 2203272, ster.2200079.According to the information received, patient presented with infection, caused by c-acne, on date unknown.Prima implants originally implanted on 19th august 2022 were removed and so was smr eccent.Glenosphere ø 40mm.Patient -male.Date of birth - (b)(6) 1936.Event happened in us.

• Brand Name: ECCENTRICAL GLENOSPHERE DIA. 40 MM
• Type of Device: ECCENTRICAL GLENOSPHERE DIA. 40 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale, 52; villanova di san daniele, udine 33038
• MDR Report Key: 16003946
• MDR Text Key: 305695666
• Report Number: 3008021110-2022-00135
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K163397
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1376.09.041
• Device Catalogue Number: 1357.14.034
• Device Lot Number: 2203272
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male