MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GLENOID BASEPLATE SMALL-R; SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R

Model Number 1375.15.605

Device Problems Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); Discomfort (2330)

Event Date 01/02/2021

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr reverse implant performed on (b)(6) 2021, due to infection.According to the complaint source, patient was doing well until (b)(6) 2020, when they went to after-hours clinic with increased discomfort.It was reported that x-rays taken a few days later (on (b)(6) 2020) showed signs of glenoid component loosening with infection.The entire prosthesis was removed: · smr glenoid baseplate small-r (product code 1375.15.605, lot #2011657 - ster.(b)(4)) · smr glenoid peg tt small-r #m (product code 1375.14.652, lot #2013552 - ster.(b)(4)) · smr finned short stem d.14 (product code 1304.15.014, lot #1921374 - ster.(b)(4)) · smr reverse humeral body short (product code 1352.15.005, lot #2011651 - ster.(b)(4)) · smr reverse liner +3mm d.40mm (product code 1365.50.815, lot #20at0r0 - ster.(b)(4)) · smr glenosphere ø 40mm (product code 1374.09.121, lot #1814202 - ster.(b)(4)) · smr small-r connector +2 (product code 1374.15.312, lot #2008543 - ster.(b)(4)) · bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2013278 - ster.(b)(4)) · bone screw ø6,5 h.30mm (product code 8420.15.030, lot #2012113 - ster.(b)(4)) culture samples were taken during revision surgery: they indicated pathogen to be (b)(6).A cemented antibiotic spacer was placed in.A long course of antibiotic therapy was given to the patient.According to the reported information, the glenoid is severely eroded.Surgeon has requested a patient-matched glenoid component to reconstruct the glenoid (surgery not yet planned).Previous surgery took place on (b)(6) 2020.Patient is a female, (b)(6).It was reported she has lupus.Event happened in the us.

Manufacturer Narrative

By checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the components with the same lot #s.Therefore, all the products placed on the market with these lots have been regularly sterilized before being placed on the market.No additional details were available on this post-operative issue, specifically pre-operative x-rays related to the revision surgery were requested to the complaint source, but they were not available.Explants not available to be returned to limacorporate for further analysis.Based on the very few information received, we are not able to further investigate the root cause of the event.However, stating that the check of the sterilization charts highlighted no anomalies on the components manufactured with the same lot #s of the items involved in the event, we can conclude 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 combined initial-final mdr.

• Brand Name: SMR GLENOID BASEPLATE SMALL-R
• Type of Device: SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12369956
• MDR Text Key: 280587177
• Report Number: 3008021110-2021-00059
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K133349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/03/2021

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 Operator: No Information
• Device Model Number: 1375.15.605
• Device Lot Number: 2011657
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other