MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR REVERSE HUMERAL BODY; SMR SHOULDER SYSTEM - 140° REVERSE HUMERAL BODY

Model Number 1352.15.011

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Arthralgia (2355)

Event Date 08/06/2021

Event Type  Injury  

Event Description

Revision surgery performed on (b)(6) 2021, due to pain.There was no evidence of gross infection and no significant fluid.Frozen cultures also came back negative.The limacorporate humeral components and third-party glenoid components were removed.Again, extensive irrigation and debridement was performed.Components explanted: smr reverse humeral body (product code 1352.15.011, lot 2021464, sterilization 2100020).Smr reverse liner + 3 mm (product code 1360.50.815, lot 20at463, sterilization 2000405).During the follow up performed on (b)(6) 2021, the surgeon noted that cultures did grow out one colony of p.Acnes.During the follow up performed on (b)(6) 2021, a ct scan and x-ray taken indicated broken screws and loosening of the custom-made portion of the implant (not limacorporate).The surgeon was not sure if the loosening was septic or aseptic.The patient was a female, 59 years old.Patient's shoulder clinical history is the following: the primary implant took place in on (b)(6) 2016 using third-party components.The implant using components of limacorporate was performed on (b)(6) 2019.First revision surgery of the lima implant took place on (b)(6) 2019, due to infection, registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00086.Second revision surgery of the lima implant took place on (b)(6) 2020, due to infection, registered with the internal complaint 242/22 and reported with the mfr 3008021110-2022-00089.Third revision surgery of the lima implant took place on (b)(6) 2020, due to bruising and arm pain, registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00087.Fourth revision surgery of the lima implant took place on (b)(6) 2021, due to pain and loss of range of motion, registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00088.Fifth revision surgery of the lima implant took place on (b)(6) 2021, due to pain (hereby reported).Sixth revision surgery of the lima implant took place on (b)(6) 2021, due to broken screw (not limacorporate) and infection, registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00091.

Manufacturer Narrative

The sterilization and manufacturing charts of the involved devices were checked with the following results: no pre-existing anomaly on the 63 smr reverse humeral body that belong to product code 1352.15.011, lot 2021464, sterilization 2100020.No pre-existing anomaly on the 58 smr reverse liner + 3 mm that belong to product code 1360.50.815, lot 20at463, sterilization 2000405.Therefore, we can state that the involved components were regularly sterilized before being placed on the market.We will submit a final report after the conclusion of the investigation.According to the fda communication received on (b)(6) 2022 by email, this report was delayed due to the enrollment process.

Manufacturer Narrative

Investigation the sterilization and manufacturing charts of the involved devices were checked with the following results: - no pre-existing anomaly on the 63 smr reverse humeral body that belong to product code 1352.15.011, lot 2021464, sterilization 2100020 - no pre-existing anomaly on the 58 smr reverse liner + 3 mm that belong to product code 1360.50.815, lot 20at463, sterilization 2000405 therefore, we can state that the involved components have followed the regular procedures before being placed on the market.Explants and x-rays analysis while the explants were not available to be returned, the complaint source shared the x-rays taken on (b)(6) 2021, and on (b)(6) 2021, and these documents were sent to a medical consultant, in order to ask for his evaluation.According to the medical expert's opinion, the provided radiographs show osteolysis at the proximal humerus and the amount of possible malalignment of the humeral component can be only guessed because of the missing landmarks.No sign of implant-related problem is visible looking at the x-rays and the most likely reason for the revision(s) is infection and therefore a fateful cause of events.In conclusion, considering that: - no pre-existing anomaly was found by checking the manufacturing and sterilization charts of the products belonging to the lot numbers involved.- according to the evaluation performed by the medical expert, no sign of implant-related problem is visible looking at the x-rays and the most likely reason for the revision(s) is infection and therefore a fateful cause of events.We can suppose that the event was not product related.Pms data according to the pms data, the revision rate of the smr reverse prostheses due to pain is around (b)(4)%.No corrective actions are required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final report.

Event Description

Revision surgery performed on b)(6), 2021, due to pain.There was no evidence of gross infection and no significant fluid.Frozen cultures also came back negative.The limacorporate humeral components and third-party glenoid components were removed.Again, extensive irrigation and debridement was performed.Components explanted: - smr reverse humeral body (product code 1352.15.011, lot 2021464, sterilization 2100020) - smr reverse liner + 3 mm (product code 1360.50.815, lot 20at463, sterilization 2000405) during the follow up performed on (b)(6) 2021, the surgeon noted that cultures did grow out one colony of p.Acnes.During the follow up performed on (b)(6) 2021, a ct scan and x-ray taken indicated broken screws and loosening of the custom-made portion of the implant (not limacorporate).The surgeon was not sure if the loosening was septic or aseptic.The patient was a female, 60 years old.Patient's shoulder clinical history is the following: the primary implant took place in 2016 using third-party components.The implant using components of limacorporate was performed on (b)(6) 2019.First revision surgery of the lima implant took place on (b)(6) 2019, due to infection, registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00086 second revision surgery of the lima implant took place on (b)(6) 2020, due to infection, registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00089.Third revision surgery of the lima implant took place (b)(46 2020, due to bruising and arm pain, registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00087 fourth revision surgery of the lima implant took place on (b)(6) 2021, due to pain and loss of range of motion, registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00088.Fifth revision surgery of the lima implant took place on (b)(6) 2021, due to pain (hereby reported).Sixth revision surgery of the lima implant took place on (b)(6) 2021, due to broken screw (not limacorporate) and infection, registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00091.After the sixth revision surgery, the patient underwent a custom-made implant surgery, but after the surgery the custom implant was found loose, and the seventh revision surgery will be performed.Event happened in united states.

• Brand Name: SMR REVERSE HUMERAL BODY
• Type of Device: SMR SHOULDER SYSTEM - 140° REVERSE HUMERAL BODY
• 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: 15650649
• MDR Text Key: 302248132
• Report Number: 3008021110-2022-00090
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K201905
• 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: 08/09/2023

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: 1352.15.011
• Device Catalogue Number: 1352.15.011
• Device Lot Number: 2021464
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 08/09/2023
• 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