MAUDE Adverse Event Report: LIMACORPORATE SPA SMR GLENOSPHERE Ø36MM SMALL-R

Model Number 1376.09.025

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of the involved lot#s no pre - existing anomaly was found.We will submit a final report once the investigation will be concluded.

Event Description

Primary shoulder reverse arthroplasty was performed on (b)(6) 2018.Since the primary surgery took place, the patient has been suffering of swelling and pus of unknown cause.Test resulted to be negative for exposure to bacteria and infection source has not been identified yet.It has been reported that probably the patient is allergic to metal.Revision surgery will be performed as soon a solution for the patient will be define.The component implanted during the primary surgery are the following: smr cementless finned stem, code 1304.15.160, lot #1800893, ster.1800107.Smr reverse humeral body, code 1352.15.010, lot #1802167, ster.1800073.Smr reverse liner + 3 mm, code 1360.50.015, lot #17at25u, ster.1800011.Smr metal-back glenoid small r, code 1375.21.005, lot #1801431, ster.1800073.Smr glenosphere ø36mm small-r, code 1376.09.025, lot #1704993, ster.1700150.Bone screw ø6,5 h.25mm, code 8420.15.020, lot #1714960, ster.1800028.Bone screw ø6,5 h.40mm, code 8420.15.050, lot #1518227, ster.1500396.Event occurred in (b)(6).

• Brand Name: SMR GLENOSPHERE Ø36MM SMALL-R
• Type of Device: SMR GLENOSPHERE Ø36MM SMALL-R
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: federica malvaso ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8627569
• MDR Text Key: 145650068
• Report Number: 3008021110-2019-00060
• 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
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1376.09.025
• Device Lot Number: 1704993
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention