MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM

Model Number 1304.15.150

Device Problem Patient Device Interaction Problem (4001)

Event Date 08/15/2023

Event Type  Injury  

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the devices.Therefore, the products with these lot#s have been properly sterilized before being placed on the market.The items involved were not available to be returned to lima corporate for further analysis.No additional details were available on this post-operative issue, specifically no pre-operative or post-operative x-rays related to the 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: (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Lima corporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2023, due to infection.It was reported that all implants were loose and got easily explanted: smr cementless finned stem (product code: 1304.15.150, lot#: 2208628 - ster.2200146).Smr reverse finned humeral body (product code 1352.15.050, lot#: 2206829 - ster.2200113).Smr reverse hp liner short (product code: 1365.09.010, lot#: 2211966 - ster.2200172) - product not sold in the us.Smr connector small r (product code: 1374.15.305, lot#: 2213987 - ster.2200168).Smr reverse hp glenosphere 40 mm (product code: 1374.50.400, lot#: 2212450 - ster.2200167) - product not sold in the us.Smr uncemented glenoid#: small-r (product code: 1375.20.005, lot#: 2212986 - ster.2200188) - product not sold in the us.Bone screw ø6,5 h.20mm (product code: 8420.15.010, lot#: 2104282 - ster.2100115).· bone screw ø6,5 h.25mm (product code: 8420.15.020, lot#: 2210836 - ster.2200164).A cemented spacer was placed in, and a second surgery is going to be planned.Specimen samples were taken however the results aren't yet available.Previous surgery took place on (b)(6) 2022.Patient is a female.Event happened in new zealand.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 17630220
• MDR Text Key: 322023985
• Report Number: 3008021110-2023-00104
• 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: 08/23/2023

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: 1304.15.150
• Device Lot Number: 2208628
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2023
• 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