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 08/02/2023

Event Type  Injury  

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly were found on the devices sterilized with the same lot #s.We submit a final mdr when the investigation is complete.

Event Description

Shoulder revision surgery performed on (b)(6) 2023, due to infection.All implants were removed: smr cementless finned stem (product code 1304.15.180, lot #2103237 - ster.2100099) smr reverse finned humeral body (product code 1352.15.050, lot #2024179 - ster.2100038).Smr reverse hp liner short (product code 1365.09.010, lot #2105019 - ster.2100136) - product not sold in the us.Smr connector small r (product code 1374.15.305, lot #2107186 - ster.2100158).Smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2107672 - ster.2100153) - product not sold in the us.Smr uncemented glenoid #small-r (product code 1375.20.005, lot #2107322 - ster.2100180) - product not sold in the us.Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2108139 - ster.2100163).Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2108139 - ster.2100163).A cemented spacer was inserted.Previous surgery took place on (b)(6) 2021.Patient is a female, 63 years old.Event happened in (b)(6).

Event Description

Shoulder revision surgery performed on (b)(6) 2023, due to infection.All implants were removed: smr cementless finned stem (product code 1304.15.180, lot #2103237 - ster.2100099).Smr reverse finned humeral body (product code 1352.15.050, lot #2024179 - ster.2100038).Smr reverse hp liner short (product code 1365.09.010, lot #2105019 - ster.2100136) - product not sold in the us.Smr connector small r (product code 1374.15.305, lot #2107186 - ster.2100158).Smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2107672 - ster.2100153) - product not sold in the us.Smr uncemented glenoid #small-r (product code 1375.20.005, lot #2107322 - ster.2100180) - product not sold in the us.Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2108139 - ster.2100163).Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2108139 - ster.2100163).A cemented spacer was inserted.Previous surgery took place on (b)(6) 2021.Patient is a female, 63 years old.Event happened in new zealand.

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly were found on the devices sterilized with the same lot #s.Therefore, products placed on the market with those lot #s 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 of specimen analysis.Based on the very few information received, we are not able to further investigate the root cause of the event.Considering that check of sterilization charts highlighted no anomalies on components manufactured with involved lot #s, we can state that the event was not product related.Pms data according to limacorporate pms data, revision rate of smr reverse prosthesis 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 final mdr.

• 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: 17487294
• MDR Text Key: 320666588
• Report Number: 3008021110-2023-00100
• 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: 12/06/2023

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: 1304.15.180
• Device Lot Number: 2103237
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2023
• 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): Required Intervention