MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR REVERSE HUMERAL BODY; SMR SHOULDER SYSTEM - REVERSE HUMERAL BODY FOR ELECTIVE SURGERY

Model Number 1352.15.010

Device Problem Patient Device Interaction Problem (4001)

Event Date 09/14/2021

Event Type  Injury  

Event Description

Revision surgery performed on september 14th, 2021, due to broken screw (not limacorporate) and infection.Both the humeral components (lima), glenoid components (third-party), and custom-made portion (third-party) were explanted.Surgeon then proceeded with an extensive irrigation and debridement.A third-party cement spacer was then placed.Components explanted: smr finned stem short d.15 (product code 1304.15.015, lot 1917010, sterilization 2000019).Smr reverse humeral body (product code 1352.15.010, lot 2105139, sterilization 2100133).Smr reverse liner + 3 mm (product code 1360.50.815, lot 20at463, sterilization 2000405).During the follow up performed on december 9th,2021, cultures from (b)(6) 2021, show no infection and has completed infectious medication.The patient was a female, 59 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 surg.Ery 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)(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 registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00090.Sixth revision surgery of the lima implant took place on (b)(6) 2021, due to broken screw (not limacorporate) and infection (hereby reported).

Manufacturer Narrative

The sterilization charts of the involved devices were checked with the following results: no pre-existing anomaly on the 15 smr finned stem short d.15 that belong to product code 1304.15.015, lot 1917010, sterilization 2000019.No pre-existing anomaly on the 63 smr reverse humeral body that belong to product code 1352.15.010, lot 2105139, sterilization 2100133.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 charts of the involved devices were checked with the following results: no pre-existing anomaly on the 15 smr finned stem short d.15 that belong to product code 1304.15.015, lot 1917010, sterilization 2000019.No pre-existing anomaly on the 63 smr reverse humeral body that belong to product code 1352.15.010, lot 2105139, sterilization 2100133.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.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 infection is around 0,06%.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 broken screw (not limacorporate) and infection.Both the humeral components (lima), glenoid components (third-party), and custom-made portion (third-party) were explanted.Surgeon then proceeded with an extensive irrigation and debridement.A third-party cement spacer was then placed.Components explanted: smr finned stem short d.15 (product code 1304.15.015, lot 1917010, sterilization 2000019).Smr reverse humeral body (product code 1352.15.010, lot 2105139, sterilization 2100133).Smr reverse liner + 3 mm (product code 1360.50.815, lot 20at463, sterilization 2000405).During the follow up performed on (b)(6) 2021, cultures from (b)(6) 2021, show no infection and has completed infectious medication.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 239/22 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 (b)(6) 2020, due to bruising and arm pain, registered with the internal complaint 240/22 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 241/22 and reported with the mfr 3008021110-2022-00088.Fifth revision surgery of the lima implant took place on (b)(6) 2021, due to pain registered with the internal complaint 243/22 and reported with the mfr 3008021110-2022-00090.Sixth revision surgery of the lima implant took place on (b)(6) 2021, due to broken screw (not limacorporate) and infection (hereby reported).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 - REVERSE HUMERAL BODY FOR ELECTIVE SURGERY
• 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: 15650646
• MDR Text Key: 302197556
• Report Number: 3008021110-2022-00091
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K110598
• 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

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1352.15.010
• Device Lot Number: 2105139
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2022
• 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