MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR GLENOSPHERE Ø 40MM

Model Number 1374.09.121

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 10/21/2022

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #'s, 20at1k8 and #2209387 no pre-existing anomaly was found.This is the first and only complaint received on these lot #'s.We will submit a final report when the investigation is complete.

Event Description

A shoulder revision surgery was performed on (b)(6) 2022.Intraoperatively, there was a mild amount of fluid which was cultured (no results); extensive irrigation and debridement were performed.Greater tuberosity was noted to be devoid due to previous surgery and injuries.Humeral stem, body, liner was removed, and humeral shaft was debrided.The glenosphere was then removed (baseplate wasn't) followed by another i&d.New lateralized components were placed.Excellent range of motion and stability in all planes was achieved, including axial loading and traction.Previous surgery - (b)(6) 2022.Patient - male.Date of birth - (b)(6) 1952.Age - 71.Event happened in the u.S.The following component s were explanted: reverse #short hum.Body 140°, commercial code 1352.15.015 - lot #2208107 - ster.#2200121.Smr reverse liner +3mm d.40mm, commercial code 1365.50.815 - lot #20at1k8 - ster.#2000309.Smr glenosphere ø 40mm, commercial code 1374.09.121 - lot #2209387 - ster.#2200121.Smr small-r connector +4, commercial code 1374.15.314 lot #2114865 ster.#2100298.

• Brand Name: SMR GLENOSPHERE Ø 40MM
• Type of Device: SMR GLENOSPHERE Ø 40MM
• 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: 17132905
• MDR Text Key: 317212478
• Report Number: 3008021110-2023-00066
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K163397
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1374.09.121
• Device Lot Number: 2209387
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male