MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.18MM

Model Number 1304.15.180

Device Problem Patient Device Interaction Problem (4001)

Event Date 08/04/2023

Event Type  Injury  

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.

Event Description

Shoulder revision surgery performed on (b)(6) 2023, due to infection.The whole prothesis was removed: · smr cementless finned stem (product code 1304.15.180, lot #1901311 - ster.1900112) · smr reverse humeral body (product code 1352.20.010, lot #1908268 - ster.1900242) - product not sold in the us.· smr reverse hp lateralized liner medium (product code 1362.09.115, lot #1819258 - ster.1900031) - product not sold in the us.· smr connector small std (product code 1374.15.310, lot #1905867 - ster.1900134) · smr reverse hp corrective glenosphere (product code 1374.50.444, lot #1817870 - ster.1800391) - product not sold in the us.· smr uncemented glenoid # std (product code 1375.20.010, lot #1906992 - ster.1900206) - product not sold in the us.· bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1907875 - ster.1900203) · bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1907875 - ster.1900203) a cement spacer was implanted.The patient got then revised on (b)(6) 2023, due to persistent infection.During it a fragment of the bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1907875 - ster.1900203) was removed.The fragment was left in during the revision surgery on (b)(6) 2023, because digging it out and removing it would have created more damage to the glenoid than necessary.The event was registered as complaint #350_23 and reported to the tga.Primary surgery was performed on (b)(6) 2019.Patient is a male, 64 years old.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.All the products placed on the market with these lots have been properly sterilized before being placed on the market.No additional details were available on this post-operative issue, specifically the following information was requested to the complaint source, but it was not available: pre-operative x-rays related to the revision surgery; clinical data for the patient; results from specimen testing.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that the check of sterilization charts highlighted no anomalies on the components manufactured with the involved lot #s, we can state that the event was not product related.Pms data: according to limacorporate pms data, the revision rate of smr reverse prostheses due to infection is 0.08%.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 reverse prosthesis performed on (b)(6) 2023 due to infection.The whole prothesis was removed: smr cementless finned stem (product code 1304.15.180, lot #1901311 - ster.1900112).Smr reverse humeral body (product code 1352.20.010, lot #1908268 - ster.1900242) - product not sold in the us.Smr reverse hp lateralized liner medium (product code 1362.09.115, lot #1819258 - ster.1900031) - product not sold in the us.Smr connector small std (product code 1374.15.310, lot #1905867 - ster.1900134).Smr reverse hp corrective glenosphere (product code 1374.50.444, lot #1817870 - ster.1800391) - product not sold in the us.Smr uncemented glenoid # std (product code 1375.20.010, lot #1906992 - ster.1900206) - product not sold in the us.Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1907875 - ster.1900203).Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1907875 - ster.1900203).It was as well reported that the cement from the primary surgery was removed from the humeral canal.A cement spacer was implanted.Specimen were taken however the results were not available.The patient got then revised on (b)(6) 2023 due to persistent infection.During it a fragment of the bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1907875 - ster.1900203) was removed.The fragment was left in during the revision surgery on (b)(6) 2023 because digging it out and removing it would have created more damage to the glenoid than necessary.The event was registered as complaint #350_23 and reported to the fda by mfr 3008021110-2023-00119.Primary surgery was performed on (b)(6) 2019.Patient is a male, 64 years old.No other clinical information was shared.Event happened in australia.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.18MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18012989
• MDR Text Key: 326630875
• Report Number: 3008021110-2023-00120
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.180
• Device Lot Number: 1901311
• 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): Other