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 Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Laxity (4526)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of the involved lots #1811413 and #2003258, no pre-existing anomaly was found on the components manufactured with those lot #s.We submit a final mdr when the investigation is completed.

Event Description

Shoulder revision surgery performed on (b)(6) 2022, due to loosening of the baseplate.It was reported that the event could have been possibly caused by infection, and swabs and samples were taken.According to the received information, glenoid components came out as one construct and were all removed: smr glenoid baseplate small-r (product code 1375.15.605, lot #1811413 - ster.1800266).Smr glenoid peg tt small-r #m (product code 1375.14.652, lot #2003258 - ster.2000130).Smr connector small r (product code 1374.15.305, lot #2005409 - ster.2000172).Smr eccentric glenosphere ø 36mm (product code 1376.09.031, lot #2000442 - ster.2000028).Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2006423 - ster.2000209).Bone screw ø6,5 h.30mm (product code 8420.15.030, lot #2005315 - ster.2000181).The prosthesis was converted to cta hemi.Previous surgery took place on (b)(6) 2020.Patient is a female, 69 years old.Event happened in new zealand.

Manufacturer Narrative

Checking the manufacturing charts of the involved lots #1811413 and #2003258, no pre-existing anomaly was found on the components manufactured with those lot #s.Further checking the sterilization charts of all involved devices, no pre-existing anomaly was found on the components.Therefore, the products placed on the market with those lot #s have been properly sterilized before being placed on the market.The items involved were not available to be returned to limacorporate for further analysis.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; · pathogen responsible for the infection; · clinical data for the patient.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that: · check of the manufacturing charts highlighted no anomalies on the components manufactured with lots #1811413 and #2003258; · it was confirmed that infection was present; · check of the sterilization charts of all involved devices highlighted no anomalies on the components; 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 loosening is 0.09%.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 loosening of the baseplate.It was reported that the event could have been possibly caused by infection, thus swabs and samples were taken.It was then reported that infection was present (pathogen not known).According to the received information, glenoid components came out as one construct and were all removed: · smr glenoid baseplate small-r (product code 1375.15.605, lot #1811413 - ster.1800266).· smr glenoid peg tt small-r #m (product code 1375.14.652, lot #2003258 - ster.2000130).· smr connector small r (product code 1374.15.305, lot #2005409 - ster.2000172).· smr eccentric glenosphere ø 36mm (product code 1376.09.031, lot #2000442 - ster.2000028).· bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2006423 - ster.2000209).· bone screw ø6,5 h.30mm (product code 8420.15.030, lot #2005315 - ster.2000181).The prosthesis was converted to cta hemi.Previous surgery took place on (b)(6), 2020.Patient is a female, 69 years old.Event happened in new zealand.

• 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: 15649313
• MDR Text Key: 302170566
• Report Number: 3008021110-2022-00101
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

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: 1375.15.605
• Device Lot Number: 1811413
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2023
• 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