MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM

Model Number 1304.15.200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the components that were released on the market with the same lot #s.We will submit a final mdr as soon as the investigation will be completed.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6), 2022, due to infection.It was reported that all implanted components were removed: smr cementless finned stem (product code 1304.15.200, lot #1908653 - ster.1900323).Smr reverse humeral body (product code 1352.20.010, lot #2013105 - ster.2000294) - product not sold in the us.Smr reverse hp liner medium (product code 1365.09.015, lot #2009844 - ster.2000220) - product not sold in the us.Smr connector small std (product code 1374.15.310, lot #1921914 - ster.2000039).Smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2014685 - ster.2000265) - product not sold in the us.Smr uncemented glenoid # std (product code 1375.20.010, lot #2002260 - ster.2000079) - product not sold in the us.Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2014543 - ster.2000923).Bone screw ø6,5 h.35mm (product code 8420.15.040, lot #2006390 - ster.2000206).A temporary bone cement was placed in.Specimen were taken for analysis.According to the complaint source, the revision surgery will be performed once the infection is treated.Previous surgery took place on (b)(6) 2020.Patient is a male, (b)(6).Event happened in (b)(6).

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found.Therefore, the products 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 a total of two x-rays referring to pre-operative revision surgery.The x-rays received - dated september 2021 - have been evaluated by a medical consultant.Following, the medical consultant comments: "the radiographs look unremarkable.The clinical reason for revision was infection, negative cultures do not rule out infection, it is the surgeon's diagnosis that counts.I do not see any implant related issue here.It is all a fateful cause of events".Considering that: · check of the sterilization charts highlighted no anomalies on the components manufactured with the involved lot #s; · no growth was observed over 14 days incubation on specimen taken from glenoid components; · according to the medical consultant "the clinical reason for revision was infection, negative cultures do not rule out infection"; we can state that the event was not product related.Pms data according to limacorporate pms data, revision rate of smr reverse due to infection is 0.069%.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) 2022, due to infection.It was reported that all implanted components were removed: · smr cementless finned stem (product code 1304.15.200, lot #1908653 - ster.1900323) · smr reverse humeral body (product code 1352.20.010, lot #2013105 - ster.2000294) - product not sold in the us · smr reverse hp liner medium (product code 1365.09.015, lot #2009844 - ster.2000220) - product not sold in the us · smr connector small std (product code 1374.15.310, lot #1921914 - ster.2000039) · smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2014685 - ster.2000265) - product not sold in the us · smr uncemented glenoid # std (product code 1375.20.010, lot #2002260 - ster.2000079) - product not sold in the us · bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2014543 - ster.2000293) · bone screw ø6,5 h.35mm (product code 8420.15.040, lot #2006390 - ster.2000206) a temporary bone cement was placed in.Specimen were taken for analysis.According to the complaint source, the revision surgery will be performed once the infection is treated.No growth was observed over 14 days incubation on swabs taken from glenoid components.Previous surgery took place on (b)(6) 2020.Patient is a male, 65 years old.He has a bmi of 27.1.Event happened in australia.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 13730227
• MDR Text Key: 287107371
• Report Number: 3008021110-2022-00013
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.200
• Device Lot Number: 1908653
• 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