MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM

Model Number 1304.15.160

Device Problem Patient Device Interaction Problem (4001)

Event Date 01/27/2021

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2021, due to suspected infection.The following components got explanted and replaced with new devices: · smr cementless finned stem (product code 1304.15.160, lot #1914651 - ster.1900379).· smr reverse finned humeral body (product code 1352.15.050, lot #1907049 - ster.1900191).· smr reverse hp liner medium (product code 1365.09.015, lot #1919049 - ster.1900463) - product not sold in the us.· smr connector small r (product code 1374.15.305, lot #1920749 - ster.2000011).· smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2003718 - ster.2000072) - product not sold in the us.The patient was then revised on (b)(6), 2023, due to implant loosening (the event was registered as complaints #359_23 and reported to the fda by mfr 3008021110-2023-00123).Primary surgery took place on (b)(6) 2020.Patient is a female, 69 years old.Event happened in australia.

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the devices.Therefore, products with those lot #s have been properly sterilized before being placed on the market.The item involved was not available to be returned to lima-corporate for further analysis.No additional details were available on this post-operative issue, specifically pre-operative nor post-operative x-rays related to this revision surgery were accessible.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 the 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 lima-corporate pms data, revision rate of smr reverse prosthesis due to infection is 0.079%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Lima-corporate continues monitoring the market to promptly detect any similar issue.Note: this is a combined initial-final mdr.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18084999
• MDR Text Key: 327541351
• Report Number: 3008021110-2023-00122
• 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
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.160
• Device Lot Number: 1914651
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2023
• 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