MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR FINNED HUMERAL BODY; FINNED HUMERAL BODIES WITH LOCKING SCREW

Model Number 1350.15.110

Device Problem Patient Device Interaction Problem (4001)

Event Date 10/12/2023

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6), 2023, due to possible infection and lump removal.The following components got explanted: · smr finned humeral body (product code 1350.15.110, lot #1214461 - ster.(b)(4)).· neutral adaptor taper standard (product code 1330.15.270, lot #1300542 - ster.(b)(4)).· liner for metalback glenoid small-r (product code 1377.50.005, lot #1203958 - ster.(b)(4)).· smr humeral head ø42 mm (product code 1322.09.420, lot #1008212 - ster.(b)(4)).· bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1306492 - ster.(b)(4)).· bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1306495 - ster.(b)(4)).The humeral stem and the metalback were well fixed and left in situ.A cement spacer was placed in, and specimens taken for analysis.It was reported that this was the first-stage surgery of a 2-stage revision.New implants will be implanted within a few weeks.Patient is a female.Primary surgery took place on (b)(6), 2013.Event happened in australia.

Manufacturer Narrative

Checking the sterilization charts of involved lot #s, no pre-existing anomalies were found on the components manufactured with those lot #s.We submit a final mdr as soon as the investigation is complete.

Manufacturer Narrative

Checking the sterilization charts of involved lot #s, no pre-existing anomalies were found on the components manufactured with those lot #s.Therefore, all the products with those lot #s have been properly sterilized before being placed on the market.Device analysis devices involved were not available to be returned to limacorporate for further analysis.X-rays analysis no x-ray was accessible for evaluation.Other information analysis surgeon's notes were shared: they are dated (b)(6) 2023 (pre-operative notes) and (b)(6) 2023 (surgical note).The notes have been shared to a medical consultant, who commented as follows: "this is a clear case of late infection, proven by microbiology and histopathology.This is a course of fateful event, there is no sign for implant-related problems here".Considering that: · check of sterilization charts highlighted no anomalies on components sterilized with the involved lot #s; · specimen were reported to be positive for propionibacterium acnes; · according to the medical consultant "this is a clear case of late infection, proven by microbiology and histopathology"; we can state that the event was not product related.Pms data according to limacorporate pms data, the revision rate of smr anatomic prostheses (total and hemi) due to infection is (b)(6).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.

Event Description

Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2023, due to possible infection and lump removal.The following components got explanted: · smr finned humeral body (product code 1350.15.110, lot #1214461 - ster.1300104).· neutral adaptor taper standard (product code 1330.15.270, lot #1300542 - ster.1300170).· liner for metalback glenoid small-r (product code 1377.50.005, lot #1203958 - ster.1200179).· smr humeral head ø42 mm (product code 1322.09.420, lot #1008212 - ster.1000281).· bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1306492 - ster.1300171).· bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1306495 - ster.1300171).The humeral stem and the metalback were well fixed and left in situ.A cement spacer was placed in, and specimens taken for analysis.Specimen were reported to be positive for propionibacterium acnes.The second-stage revision surgery was performed on (b)(6) 2023, to remove the cement spacer and place in the definitive implant.Patient is a female.Primary surgery took place on (b)(6) 2013.Event happened in australia.

• Brand Name: SMR FINNED HUMERAL BODY
• Type of Device: FINNED HUMERAL BODIES WITH LOCKING SCREW
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 17972057
• MDR Text Key: 326124259
• Report Number: 3008021110-2023-00116
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1350.15.110
• Device Lot Number: 1214461
• 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