MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.23MM

Model Number 1304.15.230

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of the products involved, no anomalies were found on the overall number of components.Thus, we can state that all components had been properly sterilized before being placed on the market.Limacorporate received some explants pictures and a total of two x-rays referring to pre-op revision surgery.The x-rays received - dated (b)(6) 2021 have been evaluated by a medical consultant.Following, the medical consultant comments: "as far as i can see this is a straightforward infectious case.I don't see any implant-related issues here, everything looks normal".Stating that: the surgeon responsible for the revision believed the patient had an infected joint; infection was confirmed even by our medical consultant; checking the sterilization charts, no anomalies were found.We can state that the event is not product related.Pms data: according to limacorporate pms data, revision rate of smr anatomic system due to infection is (b)(4).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 combined initial-final report.

Event Description

Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2021 due to suspected infection.According to the complaint source, patient developed redness and swelling on the effected shoulder.It was reported that the patient experienced soreness and consulted the surgeon.Then, surgeon suspected of an infected joint suggesting for the revision surgery.All the components previously implanted on (b)(6) 2018 were removed.In details: smr cementless finned stem (product code 1304.15.230, lot# 1412042 - ster.1400326).Smr humeral head ø54 mm (product code 1322.09.540, lot# 1403206 - ster.1400126).Smr ecc.Adaptor taper standard (product code 1330.15.272, lot# 1502809 - ster.1500137).Smr finned humeral body (product code 1350.15.110, lot# 1614144 - ster.1700001).Smr uncement.Glenoid # std (product code 1375.20.010, lot# 1710624 - ster.1700304) - product not marketed in the us.Liner f.Met.Back glen.Standard (product code 1377.50.010, lot# 16at0cr - ster.1600179).Bone screw ø6,5 h.25mm (product code 8420.15.020, lot# 1705914 - ster.1700199).Bone screw ø6,5 h.30mm (product code 8420.15.030, lot# 1709462 - ster.1700309).It was reported that this is a staged revision.According to the complaint source, patient will be treated with antibiotics and assessed for a future revision procedure when the infection has been successfully treated.Patient info: male, bmi around 30.Event happened in (b)(6).

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.23MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12007717
• MDR Text Key: 266410299
• Report Number: 3008021110-2021-00041
• 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
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1304.15.230
• Device Lot Number: 1412042
• 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