MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GLENOSPHERE Ø 36MM; GLENOSPHERE DIA. 36 MM

Model Number 1374.09.111

Device Problem Patient Device Interaction Problem (4001)

Event Date 09/15/2022

Event Type  Injury  

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the components sterilized with the same lot #s.We submit a final mdr as soon as the investigation is completed.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2022, due to infection.The following components were explanted and replaced: smr reverse liner standard (product code 1360.50.010, lot #19at31h - ster.1900453) - product not sold in the us, smr glenosphere ø 36mm (product code 1374.09.111, lot #1912815 - ster.1900325), smr connector small r (product code 1374.15.305, lot #2103804 - ster.2100093), smr uncemented glenoid #small-r (product code 1375.20.005, lot #2101474 - ster.2100078) - product not sold in the us, bone screw ø6,5 h.30mm (product code 8420.15.030, lot #2101695 - ster.2100068), bone screw ø6,5 h.35mm (product code 8420.15.040, lot #2020452 - ster.2000401), it was reported that specimen was taken during surgery, however the results are not available and the pathogen responsible for the infection is not known.Previous surgery took place on (b)(6) 2021.Patient is a female.Event happened in australia.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2022, due to infection.The following components were explanted and replaced: · smr reverse liner standard (product code 1360.50.010, lot #19at31h - ster.1900453) - product not sold in the us · smr glenosphere ø 36mm (product code 1374.09.111, lot #1912815 - ster.1900325) · smr connector small r (product code 1374.15.305, lot #2103804 - ster.2100093) · smr uncemented glenoid #small-r (product code 1375.20.005, lot #2101474 - ster.2100078) - product not sold in the us · bone screw ø6,5 h.30mm (product code 8420.15.030, lot #2101695 - ster.2100068) · bone screw ø6,5 h.35mm (product code 8420.15.040, lot #2020452 - ster.2000401) it was reported that specimen was taken during surgery, however the results are not available and the pathogen responsible for the infection is not known.Previous surgery took place on (b)(6), 2021.Patient is a female.Event happened in australia.

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the components.Therefore, all the products with these lot #s have been properly sterilized before being placed on the market.Explants analysis the items involved were not available to be returned to limacorporate for further analysis.X-rays analysis limacorporate received one x-ray referring to pre-operative revision surgery.The x-ray received - dated 01/09/2022 - and a couple of pictures of the explanted items have been evaluated by a medical consultant.Following, the medical consultant comments: "there is obvious infection; the glenoid explant shows suspicious tissue for infection at the glenoid side.The radiograph otherwise looks unremarkable; the explants otherwise are unremarkable.There is no implant-related problem here.This is infection as the reason for revision, a fateful course of events".Considering that: · check of the sterilization charts highlighted no anomalies on the components manufactured with the involved lot #s - ster; · the pathogen responsible for the infection is not known; · according to the medical consultant "there is obvious infection; the glenoid explant shows suspicious tissue for infection at the glenoid side.The radiograph otherwise looks unremarkable"; we can state that the event was not product related.Pms data according to limacorporate pms data, the revision rate of smr reverse prosthesis due to infection is 0.075%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

• Brand Name: SMR GLENOSPHERE Ø 36MM
• Type of Device: GLENOSPHERE DIA. 36 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 15457444
• MDR Text Key: 300266207
• Report Number: 3008021110-2022-00085
• Device Sequence Number: 1
• Product Code: KWS
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1374.09.111
• Device Lot Number: 1912815
• 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