MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.19MM

Model Number 1304.15.190

Device Problem Unstable (1667)

Patient Problem Implant Pain (4561)

Event Date 09/11/2020

Event Type  Injury  

Event Description

Shoulder revision surgery of smr reverse prosthesis performed on (b)(6) 2020, due to pain and instability.The following components were explanted: smr cementless finned stem (product code: 1304.15.190, lot number: 1714284, sterilization: 1700397); smr reverse humeral body short; (product code: 1352.15.005, lot number: 1809052, sterilization: 1800222).Smr reverse liner standard (product code:1360.50.810, lot number: 18at1ha, sterilization: 1800252).According to the received information, patient had no overt signs of infection and no significant fluid.Frozen sections resulted in no acute inflammation.Cultures were taken.There was some subtle instability of the shoulder, joint had some subluxation anteriorly and posteriorly.Humeral and glenosphere were removed.The patient shows good rom and stability.Upon follow up on (b)(6) 2020, the notes say that there was a finding on infection but is not specific.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.The event was registered as (b)(4) and reported to the fda by mfr: 3008021110-2022-00103.During the second stage surgery performed on (b)(6) 2018, a competitor's glenoid component and lima's humeral components were implanted.- third revision surgery took place on (b)(6) 2020, and it was due to pain and instability (hereby reported) - 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

The manufacturing and the sterilization charts of the involved products were checked with the following results: no pre-existing anomaly was found on the 34 smr cementless finned stem that belong to product code: 1304.15.190, lot number: 1714284, sterilization: 1700397.No pre-existing anomaly was found on the 57 smr reverse humeral body short that belong to product code: 1352.15.005, lot number: 1809052, sterilization: 1800222.No pre-existing anomaly was found on the 62 smr reverse liner standard that belong to product code: 1360.50.810, lot number: 18at1ha, sterilization: 1800252.Therefore, all the products have been properly sterilized before being placed on the market.We will submit a final report as soon as the investigation is completed.

Manufacturer Narrative

Investigation: the manufacturing and the sterilization charts of the involved products were checked with the following results: no pre-existing anomaly was found on the 34 smr cementless finned stems that belong to product code 1304.15.190, lot number 1714284, sterilization 1700397.No pre-existing anomaly was found on the 57 smr reverse humeral bodies short that belong to product code 1352.15.005, lot number 1809052, sterilization 1800222.No pre-existing anomaly was found on the 62 smr reverse liners standard that belong to product code 1360.50.810, lot number 18at1ha, sterilization 1800252.Therefore, all the products have been properly sterilized before being placed on the market.Explants analysis and further information: the items involved were not available to be returned to limacorporate for further analysis.Further information was requested to the complaint source, in particular x-rays, but they were not available.Moreover, the complaint source confirmed that during the previous surgery a competitor's customized glenoid was implanted.Based on the very few information received, we are not able to further investigate the root cause of the event.In conclusion: the check of the dhr highlights no pre-existing anomalies on the components involved.According to the complaint source, during the previous surgery a competitor's glenoid component and lima's humeral components were implanted.Intraoperative lab cultures were positive lab findings (infection type not stated) so being followed by infectious disease service.For these reasons, we can suppose that the event was not product related.Pms data: according to limacorporate pms data, revision rate of smr reverse prosthesis due to instability or pain is 0.027%.No specific corrective action is needed for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final report.

Event Description

Shoulder revision surgery of smr reverse prosthesis performed on (b)(6) 2020, due to pain and instability.The following components were explanted: · smr cementless finned stem (product code 1304.15.190, lot number 1714284, sterilization 1700397).· smr reverse humeral body short (product code 1352.15.005, lot number 1809052, sterilization 1800222).· smr reverse liner standard (product code 1360.50.810, lot number 18at1ha, sterilization 1800252).According to the received information, patient had no overt signs of infection and no significant fluid.Frozen sections resulted in no acute inflammation.Cultures were taken.There was some subtle instability of the shoulder, joint had some subluxation anteriorly and posteriorly.Humeral and glenosphere were removed and replaced with the following components: · smr reverse humeral body short (product code 1352.15.005, lot number 1923280, sterilization number 2000051).· smr finned stem (product code 1304.15.190, lot number 2009886, sterilization number 2000210).· smr reverse liner (product code 1365.50.815, lot number 20at0gw, sterilization number 2000204).The patient shows good rom and stability.Upon follow up of september 23rd, 2020, the notes say that there was a finding on infection but is not specific.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 complaint #266_22.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.The event was registered as complaint #267_22 and reported to the fda by mfr 3008021110-2022-00103.During the second stage surgery performed on (b)(6) 2018, a competitor's glenoid component and lima's humeral components were implanted.Third revision surgery took place on (b)(6) 2020, and it was due to pain and instability (hereby reported) 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 complaint #270_22.Event happened in us.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.19MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 15697161
• MDR Text Key: 302701137
• Report Number: 3008021110-2022-00104
• 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,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.190
• Device Lot Number: 1714284
• Is the Reporter a Health Professional?: No
• 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