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 03/22/2022

Event Type  Injury  

Manufacturer Narrative

The sterilization charts were checked with the following results: no pre-existing anomaly was found on the 35 items, belonging to product code 1304.15.140, lot number 1505441, sterilization number 1500151.No pre-existing anomaly was found on the 63 items, belonging to product code 1352.15.010, lot number 2109883, sterilization number 2100196.No pre-existing anomaly was found on the 36 items, belonging to product code 1360.50.810, lot number 20at4uy, sterilization number 2100137.We will submit a final report as soon as the investigation is completed.

Event Description

Shoulder revision surgery performed on (b)(6) 2022, due to infection.Right reverse shoulder replacement excisional arthroplasty of both humeral and glenoid components with reimplantation of an antibiotic cement hemiarthroplasty because of "presumed infection." during the revision surgery the following components were explanted: smr cementless finned stem (product code 1304.15.140, lot number 1505441, sterilization number 1500151).Smr reverse humeral body (product code 1352.15.010, lot number 2109883, sterilization number 2100196).Reverse liner standard d.36mm (product code 1360.50.810, lot number 20at4uy, sterilization number 2100137).The patient was a female, 65 years old.Primary surgery took place in 2018, after dislocation/separation, without any implant.The total shoulder arthroplasty, using lima implants, took place on (b)(6) 2019.At the end of recovery, the patient got t-boned in a car accident that caused fractures of the right shoulder as well as a frozen shoulder.The patient was followed for one year following accident.The first revision surgery took place on (b)(6) 2021, probably due to car accident.This revision was registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-00116.The second revision surgery took place on (b)(6) 2021.This revision was registered with the internal complaint (b)(4) and reported with the mfr 3008021110-2022-000119.The third revision surgery took place on (b)(6) 2022, due to infection, hereby reported.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: 15820941
• MDR Text Key: 303906263
• Report Number: 3008021110-2022-00120
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1352.15.010
• Device Lot Number: 2109883
• 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