MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM

Model Number 1304.15.200

Device Problem Patient Device Interaction Problem (4001)

Event Date 07/06/2018

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2018, due to infection.It was reported that patient presented with pain and loss of rom, and the x-rays showed possible infection and loose glenoid implant.The following components were removed: smr cementless finned stem (product code 1304.15.200, lot #1412622 - ster.1400326).Smr reverse humeral body short (product code 1352.15.005, lot #1413216 - ster.1400340).Smr reverse liner std d.40mm (product code 1365.50.810, lot #14l0392 - ster.1400352).Smr glenosphere ø40mm (product code 1374.09.120, lot #1412273 - ster.1400290).Smr glenoid peg tt s/std/l #l (product code 1375.14.663, lot #1405963 - ster.1400148).Smr glenoid baseplate small (product code 1375.15.620, lot #1408132 - ster.1400214).Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1412757 - ster.1400352).· bone screw ø6,5 h.30mm (product code 8420.15.030, lot #1404849 - ster.1400150) according to the received information, a moderate amount of fluid was noted, and on (b)(6) 2018, cultures came back positive for p.Acnes.A third-party cement hemiarthroplasty spacer placed in.After healing, a competitor's customized glenoid was implanted due to significant bone loss.Patient is a male, 70 years old.It was reported he has a bmi of 32.Patient's history of shoulder surgeries is the following: primary surgery took place on (b)(6) 2015.First revision surgery took place on (b)(6) 2015, and it was due to rotator cuff failure.The event was registered as (b)(4).In 2016 patient had initial difficulty with load-based pain and diagnosed osteomyelitis.Based on the provided information, no component was revised.At that time patient finished oral antibiotics and showed to be clear of infection.Second revision surgery performed on (b)(6) 2018, and it was due to infection (hereby reported).Third revision surgery took place on (b)(6) 2020, and it was due to pain and instability.The event was registered as (b)(4) and reported to the fda by mfr.Fourth revision surgery performed on (b)(6) 2021, and it was due pain and bone screw migration due to patient having an injury.The event was registered as (b)(4).

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the components sterilized with the same lot #s - ster.Therefore, all the products with these lot #s have been properly sterilized before being placed on the market.No additional details were available on this post-operative issue, specifically pre-operative x-rays of the revision surgery were requested to the complaint source, however they were not available.Based on the very few information received, we are not able to further investigate the root cause of the event.Stating that: check of the sterilization charts highlighted no anomalies on the components sterilized with the involved lot #s - ster; according to the provided information, on (b)(6) 2018 cultures were positive for p.Acnes; 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.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 15673940
• MDR Text Key: 302425167
• Report Number: 3008021110-2022-00103
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.200
• Device Lot Number: 1412622
• 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