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 02/21/2020

Event Type  Injury  

Manufacturer Narrative

The sterilization 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 1352.15.010, lot 1906044, sterilization 1900197.No pre-existing anomaly on the 15 smr reverse liner +6 mm that belong to product code 1360.50.820, lot 18at292, sterilization 1900164.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.

Event Description

Revision surgery took place on (b)(6) 2020, due to infection.The surgeon noted that she does have a previous history of prosthetic joint infection.During the surgery the surgeon noted there was mild straw-colored fluid deep in her shoulder but that the shoulder was well located.Cultures were taken and the shoulder was copiously irrigated and debrided.Any devitalized tissue was removed.The following lima humeral components were removed: smr reverse humeral body (product code 1352.15.010, lot 1906044, sterilization 1900197).Smr reverse liner +6 mm (product code 1360.50.820, lot 18at292, sterilization 1900164).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 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 (hereby reported).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, registered with the internal complaint 244/22 and reported with the mfr 3008021110-2022-00091.

Manufacturer Narrative

Investigation the sterilization charts of the involved devices were checked with the following results: - no pre-existing anomaly on the 63 smr reverse humeral body belonging to product code 1352.15.010, lot 1906044, sterilization 1900197.- no pre-existing anomaly on the 15 smr reverse liner +6 mm that belong to product code 1360.50.820, lot 18at292, sterilization 1900164.Therefore, we can state that the involved components were regularly sterilized before being placed on the market.According to our information, all the (b)(4) items belonging to the product code 1352.15.010, lot 1906044, sterilization 1900197 and at least 11 out of the (b)(4) items belonging to product code 1360.50.820, lot 18at292, sterilization 1900164 have been implanted and this is the first and only complaint received on these lot numbers.Explants and x-rays analysis: no explant nor x-rays were available to be analysed, therefore we were not able to perform any further investigation.In conclusion, considering that: - no pre-existing anomaly was found by checking the sterilization and manufacturing charts of the products belonging to the lot numbers involved.- no further analysis can be performed due to the unavailability of the explants and of the x-rays.We cannot determine with certainty the root cause of this event.Nevertheless, 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 took place on (b)(6) 2020, due to infection.The surgeon noted that she does have a previous history of prosthetic joint infection.During the surgery the surgeon noted there was mild straw-colored fluid deep in her shoulder but that the shoulder was well located.Cultures were taken and the shoulder was copiously irrigated and debrided.Any devitalized tissue was removed.The following lima humeral components were removed: - smr reverse humeral body (product code 1352.15.010, lot 1906044, sterilization 1900197).- smr reverse liner +6 mm (product code 1360.50.820, lot 18at292, sterilization 1900164).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 (hereby reported).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, 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 - 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: 15650623
• MDR Text Key: 302250497
• Report Number: 3008021110-2022-00089
• 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: 1906044
• 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