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 Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Insufficient Information (4580)

Event Date 04/13/2021

Event Type  Injury  

Event Description

Shoulder revision surgery performed on (b)(6) 2021, potentially due to car accident post-surgery.During the revision surgery, the patient was revised to an anatomic configuration with a bone graft and unknown glenoid side and hemi lima humeral side.During the revision surgery the following components were explanted: smr reverse humeral body (product code: 1352.15.010, lot number: 1703055, sterilization number: 1700136); smr reverse liner standard (product code: 1360.50.810, lot number: 16at14n, sterilization number: 1700036); smr glenosphere ø36mm small-r (product code: 1374.09.105, lot number: 1814560, sterilization number: 1800315); smr glenoid peg tt small-r #m (product code: 1375.14.652, lot number: 1804710, sterilization number: 1800179); smr glenoid baseplate small-r (product code: 1375.15.605, lot number: 1814813, sterilization number: 1800317).The patient was a female, 65 years old.Patient's clinical history: 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, hereby reported.The second revision surgery took place on (b)(6) 2021.This revision was registered with the internal complaint (b)(6) and reported with the mfr 3008021110-2022-000119.The third revision surgery took place on (b)(6) 2022, due to infection.This revision was registered with the internal complaint (b)(6) and reported with the mfr 3008021110-2022-00120 event happened in united states.

Manufacturer Narrative

The manufacturing charts were checked with the following results: no pre-existing anomaly was found on the (b)(4), belonging to product code: 1352.15.010, lot number: 1703055, sterilization number: 1700136; no pre-existing anomaly was found on the (b)(4), belonging to product code: 1360.50.810, lot number: 16at14n, sterilization number: 1700036; no pre-existing anomaly was found on the (b)(4), belonging to product code: 1374.09.105, lot number: 1814560, sterilization number: 1800315; no pre-existing anomaly was found on the (b)(4), belonging to product code: 1375.14.652, lot number: 1804710, sterilization number: 1800179; no pre-existing anomaly was found on the (b)(4), belonging to product code: 1375.15.605, lot number: 1814813, sterilization number: 1800317.We will submit a final report as soon as the investigation is completed.

Manufacturer Narrative

Investigation the manufacturing charts were checked with the following results: - no pre-existing anomaly was found on the 63 items, belonging to product code 1352.15.010, lot number 1703055, sterilization number (b)(6).- no pre-existing anomaly was found on the 60 items, belonging to product code 1360.50.810, lot number 16at14n, sterilization number (b)(6).- no pre-existing anomaly was found on the 72 items, belonging to product code 1374.09.105, lot number 1814560, sterilization number (b)(6).- no pre-existing anomaly was found on the 63 items, belonging to product code 1375.14.652, lot number 1804710, sterilization number (b)(6).- no pre-existing anomaly was found on the 42 items, belonging to product code 1375.15.605, lot number 1814813, sterilization number (b)(6).No x-rays nor explants were available to be returned.However, the whole patient's history has been shared with the medical expert, asking for his evaluation.Based on his assessment: "in retrospect, all surgeries seem to be carried out in a reasonable way with good intentions and indications.The first implantation failed because of trauma, no further information about fracture pattern available.To step back to cta situation and glenoid bone grafting is a common option.To convert the hemi to rtsa in a second stage is also a reasonable indication, because of less expected pain with rtsa and better function compared to hemi.The revision for infection is a fateful course of event, a negative risk that did get realized.There is no sign of implant-related failure." therefore, considering that: - checking the manufacturing charts of the lot numbers involved in the complaint, no pre-existing anomaly was found - according to the information received by the medical expert, there is no sign of implant-related failure we can conclude that the event was not product related.Pms data: according to the relevant pms data, the revision rate of the smr reverse humeral body belonging to the family code 1352.15.Xxx and 1352.20.Xxx due to trauma is around 0.03%.No corrective action is required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further case.This is a final mdr.

Event Description

Shoulder revision surgery performed on april 13th, 2021, potentially due to car accident post-surgery.During the revision surgery, the patient was revised to an anatomic configuration with a bone graft and unknown glenoid side and hemi lima humeral side.During the revision surgery the following components were explanted: - smr reverse humeral body (product code 1352.15.010, lot number 1703055, sterilization number (b)(6)).- smr reverse liner standard (product code 1360.50.810, lot number 16at14n, sterilization number (b)(6)).- smr glenosphere ø36mm small-r (product code 1374.09.105, lot number 1814560, sterilization number (b)(6)).- smr glenoid peg tt small-r #m (product code 1375.14.652, lot number 1804710, sterilization number (b)(6)) - smr glenoid baseplate small-r (product code 1375.15.605, lot number 1814813, sterilization number (b)(6)).The patient was a female, 65 years old.Patient's clinical history: - 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, hereby reported.- the second revision surgery took place on (b)(6) 2021.This revision was registered with the internal complaint 298/22 and reported with the mfr 3008021110-2022-000119.- the third revision surgery took place on (b)(6) 2022, due to infection.This revision was registered with the internal complaint 300/22 and reported with the mfr 3008021110-2022-00120.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: 15823012
• MDR Text Key: 303903124
• Report Number: 3008021110-2022-00116
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1352.15.010
• Device Lot Number: 1703055
• 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