MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.17MM

Model Number 1304.15.170

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of the involved products, no pre-existing anomalies were found, thus we can state that all the components had been regularly sterilized before being placed on the market.Explants not available to be returned to limacorporate for further analysis.X-rays were not available for evaluation by the medical consultant.Based on the very few info received about this case, we are not able to further investigate it.We cannot go back with certainty to the root cause of the event reported, however, considering that no anomalies were found on the sterilization charts of the components involved in the complaint, it cannot be classified as product related.Pms data: according to limacorporate pms data, we can estimate a revision rate of smr reverse prosthesis due to infection to be 0,06%.No specific corrective actions for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is an initial-final combined mdr.

Event Description

Shoulder revision surgery of an smr reverse prosthesis due to infection performed on (b)(6) 2017.Previous surgery took place on (b)(6) 2015.According to the complaint source, the event was due to other internal joint prosthesis.The following components were explanted: smr cementless finned stem (product code 1304.15.170, lot# 1415092 - ster.1500068).Smr reverse humeral body (product code 1352.15.010, lot# 1503179 - ster.1500119).Smr reverse liner +3mm d.40mm (product code 1365.50.815, lot# 14l0402 - ster.1400350) smr glenosphere ø40mm small-r (product code 1374.09.115, lot# 1412310 - ster.1400290) smr glenoid peg tt small-r #l (product code 1375.14.653, lot# 1501339 - ster.1500070) smr glenoid baseplate small-r (product code 1375.15.605, lot# 1412124 - ster.1500089) bone screw ø6,5 h.35mm (product code 8420.15.040, lot# 1411468 - ster.1400292).Bone screw ø6,5 h.35mm (product code 8420.15.040, lot# 1409728 - ster.1400263).An antibiotic spacer was placed in.Since then, the patient has undergone multiple revisions with competitor's shoulder products and it was requested a patient-matched glenoid (promade 21-1038) to be implanted soon.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.17MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11705396
• MDR Text Key: 247197472
• Report Number: 3008021110-2021-00032
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1304.15.170
• Device Lot Number: 1415092
• 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